Analgesia in Laparoscopic Cholecystectomy

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388946
• Other study ID #: 149/27.5.10 & S-147/03-08-10
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: July 5, 2016
• Start date: May 2010
• Est. completion date: January 2014

Study information

• Verified date: July 2016
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine 0.75

• Normal saline

Locations

Country	Name	City	State
Greece	Aretaieio Hospital	Athens
Greece	Department of Anesthesia, St Savas Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Chronic Pain	Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively	one month postoperatively	Yes
Secondary	Chronic Pain	Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively	three months	Yes