Analgesia in Laparoscopic Cholecystectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Chronic Postoperative Pain
• Intervention / Treatment: Drug: Normal saline; Drug: Ropivacaine 0.75

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11528
    • Aretaieio Hospital
  • Athens, Greece, 11522
    • Department of Anesthesia, St Savas Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ropivacaine 0.75; Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours	Drug: Ropivacaine 0.75; Other Names: Naropeine
Placebo Comparator: Normal saline; Continuous infusion of normal saline 2 ml/h for 24 hours	Drug: Normal saline; Other Names: 0.9% saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Score Changes ( Cough) During 24 h Postoperatively	Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.	24 h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores in the Postoperative Care Unit (PACU) at Rest	Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.	in PACU
Pain Scores at Rest 2 h Postoperatively	Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.	2 h postoperatively
Pain Scores at Rest 4 h Postoperatively	Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.	4 h
Pain Scores at Rest 8 h Postoperatively	Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.	8 h
Pain Scores at Rest 24 h Postoperatively	Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.	24h
Pain Scores at Rest 48 h Postoperatively	Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.	48 h
Pain Scores During Cough in the PACU	Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.	PACU
Pain Scores During Cough 2 h Postoperatively	Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.	2 h
Pain Scores During Cough 4 h Postoperatively	Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.	4 h
Pain Scores During Cough 8 h Postoperatively	Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.	8 h
Pain Scores During Cough 48 h Postoperatively	Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.	48 h
Chronic Pain	Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively	one month postoperatively
Chronic Pain	Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively	three months

Collaborators and Investigators

• Sponsor: University of Athens
• Investigators: Principal Investigator: Emilia Vassi, St Savvas Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 7, 2011

Study Record Updates

• Last Update Posted (Estimate): July 6, 2016
• Last Update Submitted That Met QC Criteria: July 5, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: chronic pain; acute postoperative pain; late pain; wound irrigation with local anesthetic
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 149/27.5.10 & Σ-147/03-08-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share data. The study has been published