NCT02002663.

Trial name or title	Continuous wound infusion of local anaesthetic and steroid after major abdominal surgery: study protocol for a randomized controlled trial
Methods	Double‐blinded (participant and outcome assessor) clinical RCT Sequence via computer‐generated list follow‐up: 3 months
Participants	Participants: 120 men and women at university hospital in Italy Operation: major abdominal surgery by laparotomy 2 groups, size: 60/60 Age: 18‐85 years old Men/women: not reported Exclusion criteria: regular use of opioid analgesics, history of drugs or alcohol abuse (or both), postoperative hospitalisation in intensive care with sedation or mechanical ventilation (or both), neurological disorders, any heart conduction disease, any cognitive or mental disorder hindering a participant from providing informed consent, BMI > 30, diabetes (type I or II), allergy to study drugs, and use of epidural analgesia
Interventions	Group 1 (ropivacaine infusion): GA is given using propofol and midazolam (as deemed appropriate by the anaesthesiologist), opioids (fentanyl 0.2 μg/kg or remifentanil 0.1‐0.25 mg/kg/min or both), and muscle relaxants (cisatracurium/rocuronium) and maintained with sevoflurane. A morphine bolus of 0.15 mg/kg is given 30‐45 min before the end of surgery. An infusion catheter is placed by the surgeon in the fascial plane between peritoneum and fascia transversalis, and a 10 mL bolus of 0.2% ropivacaine is administered immediately after muscular plane closure; the catheter is then connected to an electronic pump to give a continuous infusion of pain medications. During the first 24 h, all participants receive ropivacaine 0.2% + methylprednisolone 1 mg/kg, 10 mL/h (total volume of 240 mL in 24 h) continuous wound infusion; additionally, either paracetamol (acetaminophen) 1000 mg or ketorolac 30 mg every 8 h is prescribed. Rescue analgesia in the first 48 h is provided by PCA pump with morphine (0.5 mg/mL, bolus 1 mg, lock‐out 5 min, 20 mg limit every 4 h) Group 2 (control): exactly the same as above, except after 24 h, 10 mL/h continuous infusion of saline 0.9% given to control group Adjuvants: methylprednisolone Immediate post‐op pain control: not reported
Outcomes	Dichotomous: none Continuous: NRS Other reported: acute postoperative pain, use of morphine equivalents, analgesic consumption, side effects (postoperative nausea and vomiting, sedation, and any signs of LA or steroid systemic toxicity), and differences in terms of wound healing or wound infections.
Starting date	October 2013
Contact information	Dario Bugada, M.D. Email: dariobugada@gmail.com
Notes	ClinicalTrials.gov Identifier: NCT02002663