Pilot double-blinded study to assess efficacy and tolerability of morphine sulphate oral solution (Oramorph®) given preoperatively as add-on therapy within a multimodal postoperative pain approach in patients undergoing laparoscopic cholecystectomy.

BACKGROUND: This study aims at investigating the effect of a single pre-operative oral administration of morphine sulphate (Oramorph®) on pain after laparoscopic cholecystectomy (LC). METHODS: Forty-one ASA I-III patients, aged 18-65 years, undergoing LC were randomly, double-blindly allocated to treatment (N.=20, 30mg Oramorph®, group M) or placebo (N.=21, group P). General anesthesia was maintained with propofol and remifentanil. All patients received ketamine 0.2 mg/kg iv at induction, intraoperative ketorolac 30mg iv and tramadol postoperatively (iv PCA: bolus 50 mg, lock-out 30 min, max 100 mg/4 hours). Numerical rating scale for pain (NRS), White's fast track and PADSS scores, tramadol consumption and adverse events were recorded for the first 24h. All patients underwent State Trait Anxiety Inventory (STAI) and Mini Mental State Examination (MMSE). RESULTS: Anthropometric characteristics, MMSE, STAI, ASA status, NRS rest, White's and PADDS scores, PONV incidence were similar. Group M showed significantly lower NRS on movement during the first 3 hours after awakening. Cumulative tramadol consumption was lower in group M than in group P (185±142 mg versus 263±199 mg, P=0.199). CONCLUSION: Within a multimodal approach, a single preoperative oral administration of 30 mg of morphine sulphate in patients undergoing LC did not improve pain at rest, but improved NRS on movement during the first 3 hours after awakening. Group P required a higher mean dose of tramadol compared to Group M, although not significantly. The safety profile of Oramorph® allowed fast extubation and awakening times as well as prompt home discharge within 6 hours from surgery.

Tramadol and 0.5% levobupivacaine for single-shot interscalene block: effects on postoperative analgesia in patients undergoing shoulder arthroplasty.

BACKGROUND: The aim of this study was to evaluate the efficacy of tramadol as an adjuvant to the local anaesthetic solution in patients undergoing shoulder arthroscopy for rotator cuff tear after middle interscalene block (MIB). METHODS: We enrolled 120 patients (ASA I-II), scheduled for arthroscopic surgery for rotator cuff tear. The patients were sedated with midazolam 0.02 mg/kg and haloperidol 2 mg i.v. before performing MIB. All subjects underwent a MIB with 0.4 mL/kg of 0.5% levobupivacaine. After computerized randomization, all patients were allocated in 1 of 3 groups, each including 40 subjects. Group Placebo (Group P) received 0.4 mL/kg of 0.5% levobupivacaine plus isotonic sodium chloride for MIB and isotonic sodium chloride i.m. Group "Perineural Tramadol" (Group TPN) received 0.4 ml/Kg of 0.5% levobupivacaine plus 1.5 mg/kg of tramadol perineurally and isotonic sodium chloride i.m. Group "Intramuscular Tramadol" (Group TIM) received 0.4 ml/Kg of 0.5% levobupivacaine plus isotonic sodium chloride perineurally and 1.5 mg/kg of tramadol i.m. RESULTS: The MIB onset times were not statistically different in the three groups. The duration of analgesia was significantly longer in Groups TPN and TIM, where tramadol was administered, either i.m. or perineurally, compared with the placebo group. A significant statistical difference was found in the duration of analgesia between the group TPN and TIM. CONCLUSION: The addition of tramadol to the local anaesthetic solution administered for MIB provided a longer duration of analgesia compared with placebo and i.m tramadol administration in patients undergoing arthroscopic surgery for rotator cuff tear.