NCT01388946

Analgesia in Laparoscopic Cholecystectomy

Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy. A Randomized Controlled Double-blind Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University of Athens · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients undergoing laparoscopic cholecystectomy may modify the intensity of postoperative pain or the analgesic consumption during the first 24 hours.

Detailed description

Patients scheduled for laparoscopic cholecystectomy were randomly assigned to receive via a subcutaneous catheter 2 ml per hour of 0.75 ropivacaine or same volume of normal saline. The catheter was inserted after induction of general anesthesia and before beginning of surgery and continued for the first 24 postoperative hours. The solutions were administered by means of an elastomeric pump. Before induction of anesthesia metoclopramide 10 mg, ranitidine 50 mg and droperidol 0.75 mg were given intravenously. In the operating room the routine monitoring was applied. Anesthesia was induced with thiopental 5-6 mg/kg, fentanyl 2 μg/kg, and rocuronium 0.6 mg/kg, and maintained with sevoflurane 1-1.5 Minimum Alveolar Concentration (MAC) in a nitrous oxide/oxygen mixture. After induction of anesthesia diclofenac 75 mg I.V was given within 30 min. Before wound closure each hole was infiltrated with 2 ml of ropivacaine 0.75 or normal saline. At the end of surgery neuromuscular block was reversed with sugammadex 2 mg/kg., the patient was extubated and transferred to the Post-anesthesia Care Unit (PACU). Intra-operatively, the intra-abdominal pressure, the rate of carbon dioxide insufflation and the total amount of carbon dioxide insufflated are recorded every 5 minutes. Besides the ropivacaine infusion in the operative site, postoperative analgesia is assured in the PACU with paracetamol 1 gr and tramadol 100 mg if Visual Analogue Scale (VAS) score is above 40 mm.In the ward Lonarid tablets are given instead. VAS values and analgesic consumption are recorded in the PACU, and 2, 4, 8, 24 and 48 hours after surgery. The catheter is removed 24 hours after surgery. One and three months after surgery patients are interviewed by phone for the presence of pain due to surgery.

Conditions

• Pain, Postoperative
• Chronic Postoperative Pain

Interventions

Type	Name	Description
DRUG	Ropivacaine 0.75
DRUG	Normal saline

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-07-07
• Last updated: 2016-07-06
• Results posted: 2016-07-06

Locations

2 sites across 1 country: Greece