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Clinical Trials/NCT03069586
NCT03069586
Unknown
Not Applicable

The Effect of Low Pressure Pneumoperitoneum and Pulmonary Recruitment Manoeuvre on Postoperative Pain After Laparoscopic Cholecystectomy

General Hospital Groeninge1 site in 1 country80 target enrollmentMay 2015
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ConditionsPneumoperitoneumRecruitmentPostoperative Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumoperitoneum
Sponsor
General Hospital Groeninge
Enrollment
80
Locations
1
Primary Endpoint
pain relief during the first 24 hours
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The investigators want to test the hypothesis that the addition of a recruitment manoeuvre to a low pressure pneumoperitoneum will lead to an additional reduction in postoperative pain. Therefore the investigators will conduct a prospective randomized controlled, single blind trial.

Detailed Description

Two groups: 1. A cholecystectomy at a low pressure pneumoperitoneum (8-10 mmHg) 2. A cholecystectomy at a lowpressure pneumoperitoneum (8-10mmhg) and at the end a pulmonary recruitment manoeuvre (5 sec at max 40 cmH2O).

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
April 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
General Hospital Groeninge
Responsible Party
Principal Investigator
Principal Investigator

Casier Isabelle

Doctor

General Hospital Groeninge

Eligibility Criteria

Inclusion Criteria

  • •ASA I and II

Exclusion Criteria

  • •refusal to give consent
  • •cholecystitis
  • •BMI above 35
  • •intolerance to one of the pain medication
  • •pregnancy

Outcomes

Primary Outcomes

pain relief during the first 24 hours

Time Frame: 24hours

VAS (0-10)

Secondary Outcomes

  • Total analgesic use during the first 24 hours(24hours)
  • Length of hospital stay(2 days)
  • Recovery after 48 hours(48 hours)

Study Sites (1)

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