Analgesia in Laparoscopic Cholecystectomy

NCT ID: NCT01388946

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2014-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ropivacaine 0.75

Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.75

Intervention Type: DRUG

Normal saline

Continuous infusion of normal saline 2 ml/h for 24 hours

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Interventions

Ropivacaine 0.75

Intervention Type: DRUG

Normal saline

Intervention Type: DRUG

Other Intervention Names

Naropeine; 0.9% saline

Eligibility Criteria

Inclusion Criteria

• Patients aged 30-70 years American Society of Anesthesiology (ASA) physical status I-III
• Scheduled for laparoscopic cholecystectomy

Exclusion Criteria

• Patients with chronic pain and/or on analgesics for the last month,
• Patients with central nervous, kidney and liver disease, or allergy to local anesthetics

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Argyro Fassoulaki

MD, PhD, DEAA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emilia Vassi

Role: PRINCIPAL_INVESTIGATOR

St Savvas Hospital

Locations

Department of Anesthesia, St Savas Hospital

Athens, , Greece

Aretaieio Hospital

Athens, , Greece

Countries

Greece

Other Identifiers

149/27.5.10 & Σ-147/03-08-10

Identifier Type: -

Identifier Source: org_study_id