Analgesia in Laparoscopic Cholecystectomy

NCT01388946 | Completed Results

• 1 other identifier: 149/27.5.10 & Σ-147/03-08-10
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain, Postoperative; Chronic Postoperative Pain

Keywords

acute postoperative pain; late pain; chronic pain; wound irrigation with local anesthetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Pain Scores in the Postoperative Care Unit (PACU) at Rest

  in PACU

• Pain Scores at Rest 2 h Postoperatively

  2 h postoperatively

• Pain Scores at Rest 4 h Postoperatively

  4 h

• Pain Scores at Rest 8 h Postoperatively

  8 h

• Pain Scores at Rest 24 h Postoperatively

  24h

Study Arms (2)

Ropivacaine 0.75

ACTIVE COMPARATOR

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

Drug: Ropivacaine 0.75

Normal saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Ropivacaine 0.75 DRUG

Also known as: Naropeine

Ropivacaine 0.75

Normal saline DRUG

Also known as: 0.9% saline

Normal saline

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (2)

Department of Anesthesia, St Savas Hospital

Athens, 11522, Greece

Location

Aretaieio Hospital

Athens, 11528, Greece

Location

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Argyro Fassoulaki
• Organization: Aretaieo Hospital University of Athens

fassoula@aretaieio.uoa.gr

+30 6936701333

Study Officials

• Emilia Vassi

  St Savvas Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, DEAA

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 7, 2011
• Study Start: May 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 6, 2016
• Results First Posted: July 6, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)