Efficacy and safety of sclerotherapy with polidocanol foam in comparison with fluid sclerosant in the treatment of first-grade haemorrhoidal disease: a randomised, controlled, single-blind, multicentre trial.

PURPOSE: Sclerotherapy is the treatment of choice for first-grade haemorrhoidal disease. Numerous studies have shown that sclerotherapy with foamed sclerosants is more efficacious than liquid in the treatment of varicose veins. The aim of this study was to assess the efficacy and safety of polidocanol foam in comparison with liquid for haemorrhoidal disease. METHODS: A total of 130 patients were randomised to foam or liquid sclerotherapy (polidocanol 3%). Patients with first-grade haemorrhoidal disease were included and blinded to treatment assignment. The primary endpoint was the stopping of perianal bleeding after one sclerotherapy session. Sclerotherapy was repeated until patients were free of bleeding (2-week intervals). The final follow-up was 12 weeks after the last sclerotherapy session. RESULTS: In the foam group, significantly more patients (88%) were treated successfully after one sclerotherapy session compared to the liquid group (69%; p = 0.01). There was high patient satisfaction in both groups, but significantly more patients were satisfied with their treatment in the foam group than in the liquid group (99 vs. 84%; p = 0.009). Additionally, in the foam group, significantly less treatment sessions were required (p < 0.001), and the total amount of injected polidocanol was reduced (p < 0.001). CONCLUSION: In the therapy of first-grade haemorrhoidal disease, polidocanol 3 % foam is more effective and equally safe compared to liquid polidocanol. The results of this trial show that foam sclerotherapy is a new, innovative, effective and safe non-surgical treatment option for haemorrhoidal disease.

Randomised clinical trial of pilonidal sinus operations performed in the prone position under spinal anaesthesia with hyperbaric bupivacaine 0.5 % versus total intravenous anaesthesia.

PURPOSE: The aim of this randomised clinical trial was to determine whether spinal anaesthesia (SPA) is superior to total intravenous anaesthesia (TIVA) in patients undergoing pilonidal sinus (PS) operations in the prone position. METHODS: After approval of the local ethics committee, suitable patients aged 19-49 years were randomised to SPA (7.5 mg hyperbaric bupivacaine) or TIVA (Propofol and Fentanyl). Cumulative consumption of analgesics, postoperative recovery, complications and patient satisfaction were evaluated. RESULTS: A total of 50 patients were randomised within a 24-month period. Median monitoring time in the recovery room was 0 (0-11) min for SPA versus 40 (5-145) min for TIVA (p < 0.0001). Patients in the SPA group were able to drink (40.5 (0-327) min versus TIVA 171 (72-280) min, p < 0.0001) and eat (55 (0-333) min versus TIVA 220 (85-358), p < 0.0001) earlier. More patients with a TIVA needed analgesics in the recovery room (SPA n = 0 versus TIVA n = 6, p = 0.0023) and suffered more frequently from a sore throat (SPA n = 0 versus TIVA n = 11, p = 0.0001). Two patients with a TIVA suffered from nausea and vomiting. Patients of both groups were equally satisfied with the anaesthesia technique offered. CONCLUSIONS: SPA with 7.5 mg hyperbaric bupivacaine is superior to TIVA in patients undergoing PS operations in the prone position in terms of analgesia consumption in the recovery room, recovery times and postoperative complications.

Influence of the pre-operative time in upright sitting position and the needle type on the incidence of post-dural puncture headache (PDPH) in patients receiving a spinal saddle block for anorectal surgery.

BACKGROUND: A spinal saddle block can be a safe method for anorectal surgery with a low rate of complications when performed with the right technique. A dreaded complication is the post-dural puncture headache (PDPH), which can be decreased by the use of non-cutting spinal needles. Regrettably, cutting Quincke (Q)-type needles are still widely used for economic reasons. Besides size and design of a spinal needle, the pre-operative time in upright sitting position may also influence the incidence of PDPH after spinal saddle block. METHODS: Within 4 months, 363 patients undergoing anorectal surgery in saddle block technique were randomised to receive either a 27-gauge (G) pencil-point (PP) or a 27-G Q spinal needle and were pre-operatively left in upright sitting position for 10 or 30 min, respectively. The incidence of PDPH was assessed 1 week after the operation via a telephone interview. RESULTS: Three hundred sixty three patients (219 males/144 females) were analysed. Fifteen patients (4.1%) developed PDPH. Patients receiving spinal anaesthesia with a Q needle suffered significantly more frequently from PDPH [Q: n = 12 (6.6%) vs. PP: n = 3 (1.7%), p = 0.02], but there was no association between PDPH and pre-operative time in the upright position (p = 0.20). CONCLUSIONS: These data prove that using 27-G PP needles is the method with the fewest side effects caused by spinal saddle block, and suggest that the time spent sitting in the upright position is not clinically relevant.

High incidence of post-dural puncture headache in patients with spinal saddle block induced with Quincke needles for anorectal surgery: a randomised clinical trial.

PURPOSE: Spinal saddle block represents nearly the ideal anaesthesia technique for anorectal surgery. Post-dural puncture headache (PDPH) is a dreaded complication but can be decreased by the use of non-cutting spinal needles to rates less than 1%. Though, cutting Quincke type needles are still widely used for economic reasons, leading to a higher rate of PDPH. We performed this study to demonstrate a reduction of PDPH by the use of very small 29-G compared with commonly used 25-G Quincke type spinal needles. METHODS: Two hundred sixteen adult patients (male/female, 19-83 years, ASA status I-III) were randomised 1:1 to groups, in which either a 25-G or a 29-G Quincke type spinal needle was used for a spinal saddle block. The incidence of PDPH was assessed during 1 week after surgery. RESULTS: Thirty-nine of 216 patients developed PDPH but there was no difference between the two needle sizes (25-G, n = 18/106 vs. 29-G, n = 21/110, p = 0.6870). Women suffered significantly more from PDPH than men (23/86 vs. 16/130, p = 0.0069). Ambulatory patients had a later onset of PDPH than in-patients (24 h [0.5-72] vs. 2 h [0.2-96], p = 0.0002) and the headache was more severe in these patients (NRS 7 [2-10] vs. NRS 3 [1-8], p = 0.0009). CONCLUSIONS: The use of 29-G compared with 25-G Quincke needles led to no reduction of PDPH and is considerably higher compared with data from pencil-point needles. The use of non-cutting or pencil-point spinal needles should become the standard for performing spinal saddle block.

Influence of sedation on patients' perceptions and recovery in patients undergoing minor perianal procedures under spinal saddle block.

OBJECTIVES: Additional intra-operative sedation may help improve acceptability and comfort of anaesthesia in patients undergoing minor anorectal (perianal) procedures under spinal saddle block. This observational study was done to determine which patients request sedatives and to what extent sedatives affect the patients' recovery. SUBJECTS AND METHODS: During a 6-month period, 500 patients undergoing minor perianal procedures received 1.0 ml hyperbaric bupivacaine (0.5%). On request, a light sedation with propofol in bolus application was provided. Patients were evaluated postoperatively using a standardized questionnaire about their perceptions before, during and 48 h after the administration of anaesthesia. RESULTS: More female (91/143, 63.6%) than male (136/259, 52.5%) patients (p = 0.0312) received sedation. Patients with sedation were significantly younger (46.7 +/- 13.8 vs. 50 +/- 13.8 years, p = 0.0171) and had a lower body mass index (BMI; 25.6 +/- 4.3 vs. 27.5 +/- 5.1, p < 0.0001). Time to mobilization and first micturition was significantly longer in patients with sedation (4.8 vs. 4.4 h, p = 0.0194 and 5.8 vs. 5.4 h, p = 0.0188), which was associated with a higher incidence of nausea (7.5 vs. 1.7%, p = 0.0083). CONCLUSIONS: Female gender, younger age, lower body weight and lower BMI were associated with higher subjective requirements for sedation. The use of sedation showed prolongation of time to first mobilization and micturition and a higher incidence of nausea.

Practicability and patients' subjective experiences of low-dose spinal anaesthesia using hyperbaric bupivacaine for transanal surgery.

PURPOSE: The safety, effectiveness and long lasting post-operative analgesia make spinal anaesthesia in saddle block technique an "ideal" method for transanal surgery. To improve patient satisfaction and offer reliable operation conditions to surgeons, this study quantifies practicability and patients' subjective experiences with this technique. METHODS: Within a 5-month period, 400 consecutive patients undergoing transanal surgery in saddle block technique were evaluated by a standardised questionnaire. RESULTS: The success rate of spinal anaesthesia was 99.5%. Side effects occurred far less frequently as mentioned in the literature. The duration of the sensory block was about twice as long as the time until first mobilisation and micturition. Despite some negative experiences during the procedure, 92% of the investigated patients would choose a saddle block again. CONCLUSIONS: Both from reasons of practicability and from patients' view, spinal anaesthesia in saddle block technique can be thoroughly recommended for transanal surgery. Patients undergoing a stapler haemorrhoidectomy should receive additional opioids.