A comparison of ultrasound guided bilateral single injection shot Erector Spinae Plane blocks versus wound infiltration for post-operative analgesia in laparoscopic assisted colonic surgery- a prospective randomised study.

BACKGROUND: Both wound infiltration (WI) with local anaesthetic and Erector Spinae Plane block (ESPB) have been described for post-operative analgesia after abdominal surgery. This study compared the efficacy of WI versus ESPB for post-operative analgesia after laparoscopic assisted colonic surgery. METHODS: Seventy-two patients between 18 and 85 years of age undergoing elective surgery were randomised to receive either WI or ESPB. In the WI group a 40 ml bolus of 0.5% Ropivacaine, infiltrated at the ports and minimally invasive wound at subcutaneous and fascia layers. In the ESPB group at T8 level, under ultrasound guidance, a 22-gauge nerve block needle was passed through the Erector Spinae muscle to reach its fascia. A dose up to 40 ml of 0.5% Ropivacaine, divided into two equal volumes, was injected at each side. Both groups had a multimodal analgesic regime, including regular Paracetamol, dexamethasone and patient-controlled analgesia (PCA) with Fentanyl. The primary end point was a post-operative pain score utilising a verbal Numerical Rating Score (NRS, 0-10) on rest and coughing in the post anaesthetic care unit (PACU) and in the first 24 h. Secondary outcomes measured were: opioid usage, length of stay and any clinical adverse events. RESULTS: There was no significant treatment difference in PACU NRS at rest and coughing (p-values 0. 382 and 0.595respectively). Similarly, there were no significant differences in first 24 h NRS at rest and coughing (p-values 0.285 and 0.431 respectively). There was no significant difference in Fentanyl use in PACU or in the first 24 h (p- values 0.900 and 0.783 respectively). Neither was there a significant difference found in mean total Fentanyl use between ESPB and WI groups (p-value 0.787). CONCLUSION: Our observations found both interventions had an overall similar efficacy. TRIAL REGISTRATION: The study was registered with the Australian New Zealand Clinical Trial Registry (ACTRN: 12619000113156 ).

Comparison of ultrasound-guided transmuscular quadratus lumborum block catheter technique with surgical pre-peritoneal catheter for postoperative analgesia in abdominal surgery: a randomised controlled trial.

Following abdominal surgery, the provision of postoperative analgesia with local anaesthetic infusion through both transmuscular quadratus lumborum block and pre-peritoneal catheter have been described. This study compared these two methods of postoperative analgesia following laparotomy. Eighty-two patients 18-85 years of age scheduled to undergo elective surgery were randomly allocated to receive either transmuscular quadratus lumborum block or pre-peritoneal catheter block. In the transmuscular quadratus lumborum group, an 18-gauge Tuohy needle was passed through the quadratus lumborum muscle under ultrasound guidance to reach its anterior aspect. A 20-ml bolus of ropivacaine 0.375% was administered and catheters placed bilaterally. In the pre-peritoneal catheter group, 20 ml of ropivacaine 0.375% was infiltrated at each of three subcutaneous sub-fascial levels, and pre-peritoneal plane catheters were placed bilaterally. Both groups received an infusion of ropivacaine 0.2% at 5 ml.h-1 , continued up to 48 h along with a multimodal analgesic regime that included regular paracetamol and patient-controlled analgesia with fentanyl. The primary end-point was postoperative pain score on coughing, assessed using a numerical rating score (0-10). Secondary outcomes were pain score at rest, fentanyl usage until 48 h post-operation, satisfaction scores and costs. There was no treatment difference between the two groups for pain score on coughing (p = 0.24). In the transmuscular quadratus lumborum group, there was a reduction in numerical rating score at rest (p = 0.036) and satisfaction scores on days 1 and 30 (p = 0.004, p = 0.006, respectively), but fentanyl usage was similar. In the transmuscular quadratus lumborum group, the highest and lowest blocks observed in the recovery area were T4 and L1, respectively. The transmuscular quadratus lumborum technique cost 574.64 Australian dollars more per patient than the pre-peritoneal catheter technique.

The effect of sevoflurane on the transmural dispersion of repolarisation in patients with type 2 diabetes mellitus: a prospective observational study.

The 'torsadogenic' property of a drug is linked to its ability to increase the transmural dispersion of repolarisation, represented by the interval between the peak of, and the end of, the T-wave (Tp-e interval) in an electrocardiogram. Reports have consistently shown that sevoflurane does not increase the Tp-e interval. Type 2 diabetes is a risk factor for increased QTc (rate-corrected QT interval), QTcd (rate-corrected QTc dispersion: difference between the maximum and the minimum QTc interval), and Tp-e, as well as the rate-corrected Tp-e (Tp-e/QTc ratio). The study aimed to ascertain whether sevoflurane increased the Tp-e interval and Tp-e/QTc ratio in patients with diabetes, thereby increasing their risk of torsades. We enrolled 35 female patients; 17 with type 2 diabetes and 18 controls undergoing non-laparoscopic surgery under sevoflurane anaesthesia. The Tp-e interval, Tp-e/QTc ratio, QTc and QTcd were recorded after intubation, 5, 10, 30 and 60 minutes into the anaesthetic, and were compared between the groups. No significant increase in the Tp-e interval or Tp-e/QTc was observed between or within the groups (a 13 ms increase was considered significant). In the control group, the QTc was significantly increased from baseline immediately after intubation (449 versus 414 ms, P <0.001); at 5 minutes (434 versus 414 ms, P=0.01); at 10 minutes (444 versus 414 ms, P=0.002); at 30 minutes (439 versus 414 ms, P=0.001) and at 60 minutes (442 versus 414 ms; P <0.001) (a 20 ms increase was considered significant). No significant increase in QTc was observed in the diabetic group. There were no between or within group differences observed for QTcd. Our findings suggest that sevoflurane does not have a significant predictable pro-arrhythmic effect in type 2 diabetic patients in the absence of other factors affecting ventricular repolarisation.

Efficacy and tolerability of treatment with single doses of diethylcarbamazine (DEC) and DEC plus albendazole (ABZ) for three consecutive years in lymphatic filariasis: a field study in India.

Lymphatic filariasis (LF) affects 73 countries, causes morbidity and impedes socioeconomic development. We had found no difference in safety and micro (Mf) and macro filarial action of single-dose diethylcarbamazine (DEC) and DEC + albendazole (ABZ) in an F01 study done in India (year 2000). There was a programmatic need to evaluate safety and efficacy of multiple annual treatments (F02). Subjects (155) from the F01 study, meeting inclusion-exclusion criteria, were enrolled in F02 and treated with further two annual doses of DEC or DEC + ABZ. Efficacy was evaluated for Mf positivity by peripheral smear (PS) and nucleopore (NP) filter, circulating filarial antigen (CFA) and filarial dance sign (FDS) positivity and Mf count at yearly follow-up. Safety was assessed for 5 days after drug administration. Total of 139 subjects evaluated for efficacy (69 DEC and 70 DEC + ABZ group). Mf positivity prevalence declined progressively by 95% (PS), 66% (NP), and 95% (PS) and 86% (NP); CFA positivity prevalence declined by 15% and 9%; FDS by 100% each; Mf count declined by 75.5 and 76.9% with three annual treatment of DEC and DEC + ABZ, respectively. Addition of ABZ did not show any advantage over DEC given as three annual rounds for LF. DEC and DEC + ABZ were well tolerated. There was no correlation between result of CFA and FDS, (both claimed to be indicative of adult worm). Analysis of published studies and our data indicate that macrofilaricidal effect of DEC/DEC + ABZ may be seen in children and not adults, with three or more annual dosing.

Risk-based approach for systematic development of gastroretentive drug delivery system.

The research envisioned was the development of diltiazem hydrochloride effervescent floating matrix tablet using a risk-based approach. Preliminarily, the in vitro drug release profile was derived which theoretically simulated the in vivo condition after oral administration. Considering this as a rationale, the formulation development was initiated with defining the quality target product profile (QTPP) and critical quality attributes (CQAs). The preliminary studies were conducted to screen material attributes and process parameters followed by their risk assessment studies to select the plausible factors affecting the drug product CQAs, i.e., floating lag time and drug release profile. A 3(2) full factorial design was used to estimate the effect of the amount of swelling polymer (X 1) and gas-generating agent (X 2) on percent drug release (Q t1h and Q t8h) and floating lag time. Response and interaction plots were generated to examine the variables. Selection of an optimized formulation was done using desirability function and further validated. The model diagnostic plots represent the absence of outliers. The optimized formula obtained by the software was further validated, and the result of drug release and floating lag time was close to the predicted values. In a clear and concise way, the current investigations report the successful development of an effervescent floating matrix tablet for twice daily administration of diltiazem hydrochloride.

Evaluation of postoperative pain scores following ultrasound guided transversus abdominis plane block versus local infiltration following day surgery laparoscopic cholecystectomy-retrospective study.

BACKGROUND AND AIMS: Postoperative pain for day surgery laparoscopic cholecystectomy has traditionally been managed with the surgeon infiltrating the wound with local anesthetic (LA). However, transversus abdominis plane (TAP) block has recently been used, although its superiority over LA remains uncertain. The primary aim was to compare LA and TAP block pain scores and analgesia used. The secondary aim was to assess satisfaction score and cost. MATERIAL AND METHODS: This retrospective study was commenced after ethics committee approval and ANZ clinical trial registry (ACTRN: 12612000737831). The data were collected from the theatre database and medical records of patients presenting for day case laparoscopic cholecystectomy. The sample included patients who received either bilateral port site LA infiltration with 20 ml of 0.25% Bupivacaine or bilateral TAP block with 20 ml of 0.5% ropivacaine and fentanyl postoperative pain protocol. The patients with incomplete medical records were excluded as were those admitted to an inpatient ward. Demographics and clinical characteristics were obtained from the hospital record along with pain score and postsurgery analgesia use. Postoperative pain satisfaction scores were collected by telephonic interview 30-180 days postsurgery. RESULTS: Of 51 patients analyzed, 19 were in TAP group 29 in LA group. There were no significant differences between the LA and TAP groups with respect to postoperative pain scores (P = 0.31) or patient satisfaction scores (1 and 2+) (P = 0.36). However, fentanyl consumption in the recovery room was significantly lower in TAP group (P = 0.0079.). The consumables cost were >3 times higher in the TAP when compared to LA group. CONCLUSION: The performance of the TAP block with respect to pain management was comparable to LA. However, LA remains more cost effective.

Forced Degradation Studies of Aloe Emodin and Emodin by HPTLC.

Anthraquinones are natural phenolic compounds, which are reported to act as anti-aging, anti-inflammatory, antioxidant, anti-cancer, laxative and antitumor agents. They are abudant in plants like candle bush, aloes, cascara bark and rhubarb. The present work was to observe the effect of different forced degradation conditions by high-performance thin layer chromatography on potential markers i.e. aloe emodin and emodin. Both aloe emodin and emodin were subjected to various forced degradation studies such as oxidation, acid and alkaline hydrolysis, photolysis, hydrolytic and thermal degradation. Aloe emodin, was more susceptible to acid hydrolysis and degradation was found to a lesser extent under thermal degradation whereas significant degradation was observed under acid hydrolysis, lesser extent was observed under alkali hydrolysis for emodin. Forced degradation studies on aloe emodin and emodin gives information about its storage and intrinsic stability conditions considering the advanced pharmaceutical aspects of formulation.

Antirelapse Efficacy of Various Primaquine Regimens for Plasmodium vivax.

Background. Efficacy of standard dose of primaquine (PQ) as antirelapse for P. vivax has decreased. We aimed to assess efficacy of different PQ regimens. Methods. It was an open label, randomized, controlled, parallel group, assessor blind study comparing antirelapse efficacy of 3 PQ regimens (B = 15 mg/day × 14 days, C = 30 mg/day × 7 days, and D = 30 mg/day × 14 days) with no PQ group (A) in P. vivax patients. Paired primary and recurrence samples were subjected to 3 methods: (i) month of recurrence and genotyping, (ii) by PCR-RFLP, and (iii) PCR sequencing, to differentiate relapse and reinfection. The rates of recurrence relapse and reinfection were compared. Methods were compared for concordance between them. Results. The recurrence rate was 16.39%, 8.07%, 10.07%, and 6.62% in groups A, B, C, and D, respectively (P = 0.004). The relapse rate was 6.89%, 1.55%, 4%, and 3.85% as per the month of recurrence; 8.2%, 2%, 4.58%, and 3.68% (P = 0.007) as per PCR-RFLP; and 2.73%, 1.47%, 1.55%, and 1.53% as per PCR sequencing for groups A, B, C, and D, respectively. The concordance between methods was low, 45%. Conclusion. The higher recurrence rate in no PQ as compared to PQ groups documents PQ antirelapse activity. Regimens tested were safe. However, probable resistance to PQ warrants continuous monitoring and low concordance and limitations in the methods warrant caution in interpreting.

Development and Validation of High-performance Thin Layer Chromatographic Method for Ursolic Acid in Malus domestica Peel.

Ursolic acid, a pentacyclic triterpenoid possess a wide range of pharmacological activities. It shows hypoglycemic, antiandrogenic, antibacterial, antiinflammatory, antioxidant, diuretic and cynogenic activity. It is commonly present in plants especially coating of leaves and fruits, such as apple fruit, vinca leaves, rosemary leaves, and eucalyptus leaves. A simple high-performance thin layer chromatographic method has been developed for the quantification of ursolic acid from apple peel (Malus domestica). The samples dissolved in methanol and linear ascending development was carried out in twin trough glass chamber. The mobile phase was selected as toluene:ethyl acetate:glacial acetic acid (70:30:2). The linear regression analysis data for the calibration plots showed good linear relationship with r(2)=0.9982 in the concentration range 0.2-7 µg/spot with respect to peak area. According to the ICH guidelines the method was validated for linearity, accuracy, precision, and robustness. Statistical analysis of the data showed that the method is reproducible and selective for the estimation of ursolic acid.

A Validated High-performance Liquid Chromatograhy Method for Estimation of Ferulic Acid in Asafoetida and Polyherbal Preparation.

A high-performance liquid chromatography method was developed for the estimation of ferulic acid from asafoetida and a polyherbal preparation. The separation was carried out on HiQSil ODS C-18 column with a mobile phase of acetonitrile: 10% acetic acid (20:80 v/v). The developed method was validated as per International Conference of Harmonization guidelines for various parameters such as accuracy, precision, linearity, limit of detection, limit of quantification and specificity; and found to be reliable. Linear regression analysis showed a good corelation between peak area and concentration with a corelation coefficient r(2)=0.996 in the range 200-7000 ng/ml. The developed method can be utilized for standardization of herbal formulation comprising asafoetida.

Synthesis, Characterization and In Vitro Antimicrobial Evaluation of Novel Pyrazolothiazol-4(5H)-one Derivatives.

Antimicrobial screening of several novel pyrazolothiazol-4(5H)-one derivatives (3a-3j) has been performed. Reaction of aromatic aldehydes with aromatic ketones yielded starting chalcones (1a-1j) which have been subsequently reacted with thiosemicarbazide for obtaining N-thiocarbamoylpyrazole derivatives (2a-2j). These were further cyclized to pyrazolothiazol-4(5H)-one derivatives (3a-3j) in the presence of ethylbromoacetate. The structures of newly synthesized compounds were confirmed by FTIR and (1)H NMR and/or MS. The in vitro antimicrobial activity of these compounds was evaluated against Gram positive bacteria, Gram negative bacteria and fungi. Their minimum inhibitory concentration was determined by tube dilution method. The results showed that most of the compounds have promising antimicrobial activity as compared to standard drugs. Among the test compounds, 2-[5(4-chlorophenyl)-3-phenyl-4,5-dihydropyrazol-1-yl]-thiazol-4(5H)-one (3e) was found to show the most potent antimicrobial activity.

Epidural versus continuous transversus abdominis plane catheter technique for postoperative analgesia after abdominal surgery.

Transversus abdominis plane block is an effective postoperative analgesic technique after abdominal surgery, but no study has compared continuous transversus abdominis plane block with continuous epidural analgesia. We designed a randomised controlled trial comparing these techniques for major abdominal surgery. Patients in the epidural group received a bolus of 8 to 15 ml of ropivacaine 0.2% and an infusion of 5 to 15 ml/hour and the transversus abdominis plane block group a bolus dose of 20 ml of ropivacaine 0.375% bilaterally and an infusion of 0.2% ropivacaine 8 ml/hour bilaterally, for three days. Both groups received paracetamol and patient controlled analgesia with fentanyl for three days. Primary outcomes were numerical rating scores for pain (rest and dynamic over 72 hours) and total fentanyl use; complications and satisfaction scores were also noted. The study was terminated early after 42 patients had been randomised (epidural n=19; transversus abdominis plane block n=22; one excluded). No differences were found in regards to point pain scores or scores over time, either immediately postoperatively or in surgical wards; total fentanyl requirement and Likert satisfaction scores were also similar in both groups. In this underpowered study we found comparable results between continuous transversus abdominis plane technique and epidural analgesia in regard to pain, analgesic use and satisfaction after abdominal surgery. To confirm this finding, randomised trials with larger numbers of participants are needed.

Local responses to the Maharashtra gutka and pan masala ban: a report from Mumbai.

BACKGROUND: The Maharashtra government has banned the production, sale, distribution and storage of gutka, and pan masala in the Maharashtra State due to the increasing burden of cancer and reproductive health problems attributable to the use of these products. In view of this, it is important to understand the way producers', sellers' and users' are adapting to the ban. OBJECTIVE: During the two months following the ban (July 19 th through Sept 30, 2012), a research team studying smokeless tobacco use and promotion in a low income community of Mumbai conducted rapid surveillance to assess the impact of the ban in the study community. MATERIALS AND METHODS: Assessment involved documenting new points of sale, informal observations of tobacco use, and interviews with thirteen shop owners and eight gutka users'. Overall changes in accessibility, availability, patterns of use of tobacco products, perception of ban, social norms and surveillance activities were assessed. RESULTS: Tobacco companies were marketing new products that resembled gutka, under similar brand logos. Surveillance, financial and social cost of selling gutka or using it in public have had an immediate effect on reducing local supply, demand and use and increasing stigma associated with its use. There was an increased recognition of ill-effects of gutka on cancer among sellers' but not overall. CONCLUSIONS: To reduce the overall consumption of tobacco in the community, it is critical to include programs that create awareness about effects of smokeless tobacco on health and sustain surveillance levels. This would maintain requirements of the ban, and sustain limits on accessibility, availability and use of these products in the community and other similar communities.