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Analgesia in Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens
ClinicalTrials.gov Identifier:
NCT01388946
First received: June 29, 2011
Last updated: July 5, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Pain, Postoperative
Chronic Postoperative Pain
Drug: Ropivacaine 0.75
Drug: Normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy. A Randomized Controlled Double-blind Trial

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • VAS Score Changes ( Cough) During 24 h Postoperatively [ Time Frame: 24 h ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Pain Scores in the Postoperative Care Unit (PACU) at Rest [ Time Frame: in PACU ] [ Designated as safety issue: Yes ]
    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.

  • Pain Scores at Rest 2 h Postoperatively [ Time Frame: 2 h postoperatively ] [ Designated as safety issue: Yes ]
    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.

  • Pain Scores at Rest 4 h Postoperatively [ Time Frame: 4 h ] [ Designated as safety issue: Yes ]
    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.

  • Pain Scores at Rest 8 h Postoperatively [ Time Frame: 8 h ] [ Designated as safety issue: Yes ]
    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.

  • Pain Scores at Rest 24 h Postoperatively [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
    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.

  • Pain Scores at Rest 48 h Postoperatively [ Time Frame: 48 h ] [ Designated as safety issue: Yes ]
    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.

  • Pain Scores During Cough in the PACU [ Time Frame: PACU ] [ Designated as safety issue: Yes ]
    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.

  • Pain Scores During Cough 2 h Postoperatively [ Time Frame: 2 h ] [ Designated as safety issue: Yes ]
    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.

  • Pain Scores During Cough 4 h Postoperatively [ Time Frame: 4 h ] [ Designated as safety issue: Yes ]
    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.

  • Pain Scores During Cough 8 h Postoperatively [ Time Frame: 8 h ] [ Designated as safety issue: Yes ]
    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.

  • Pain Scores During Cough 48 h Postoperatively [ Time Frame: 48 h ] [ Designated as safety issue: Yes ]
    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.

  • Chronic Pain [ Time Frame: one month postoperatively ] [ Designated as safety issue: Yes ]
    Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively

  • Chronic Pain [ Time Frame: three months ] [ Designated as safety issue: Yes ]
    Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively


Enrollment: 110
Study Start Date: May 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ropivacaine 0.75
Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Drug: Ropivacaine 0.75
Other Name: Naropeine
Placebo Comparator: Normal saline
Continuous infusion of normal saline 2 ml/h for 24 hours
Drug: Normal saline
Other Name: 0.9% saline

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388946

Locations
Greece
Department of Anesthesia, St Savas Hospital
Athens, Greece, 11522
Aretaieio Hospital
Athens, Greece, 11528
Sponsors and Collaborators
University of Athens
Investigators
Principal Investigator: Emilia Vassi St Savvas Hospital
  More Information

Responsible Party: Argyro Fassoulaki, MD, PhD, DEAA, University of Athens
ClinicalTrials.gov Identifier: NCT01388946     History of Changes
Other Study ID Numbers: 149/27.5.10 & Σ-147/03-08-10 
Study First Received: June 29, 2011
Results First Received: May 6, 2015
Last Updated: July 5, 2016
Health Authority: Greece: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No plan to share data. The study has been published

Keywords provided by University of Athens:
acute postoperative pain
late pain
chronic pain
wound irrigation with local anesthetic

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 29, 2016