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Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain

Primary Purpose

Pneumoperitoneum, Recruitment, Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Pulmonary recruitment
No pulmonary recruitment
Sponsored by
General Hospital Groeninge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pneumoperitoneum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I and II

Exclusion Criteria:

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

Sites / Locations

  • AZ groeningeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Low pressure pneumoperitoneum

low pressure peritoneum and pulmonary recruitment

Arm Description

Surgery on low pressure pneumoperitoneum (8 - 10 mmHg).

Surgery on low pressure pneumoperitoneum (8 - 10 mmHg) and at the end of surgery a manual pulmonary recruitment manoeuver (2 x 5sec max 40cmH2O) will be done

Outcomes

Primary Outcome Measures

pain relief during the first 24 hours
VAS (0-10)

Secondary Outcome Measures

Total analgesic use during the first 24 hours
Length of hospital stay
Recovery after 48 hours
quality of recovery scale

Full Information

First Posted
February 10, 2016
Last Updated
February 27, 2017
Sponsor
General Hospital Groeninge
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1. Study Identification

Unique Protocol Identification Number
NCT03069586
Brief Title
Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain
Official Title
The Effect of Low Pressure Pneumoperitoneum and Pulmonary Recruitment Manoeuvre on Postoperative Pain After Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital Groeninge

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumoperitoneum, Recruitment, Postoperative Pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low pressure pneumoperitoneum
Arm Type
Other
Arm Description
Surgery on low pressure pneumoperitoneum (8 - 10 mmHg).
Arm Title
low pressure peritoneum and pulmonary recruitment
Arm Type
Active Comparator
Arm Description
Surgery on low pressure pneumoperitoneum (8 - 10 mmHg) and at the end of surgery a manual pulmonary recruitment manoeuver (2 x 5sec max 40cmH2O) will be done
Intervention Type
Procedure
Intervention Name(s)
Pulmonary recruitment
Intervention Description
At the end of surgery a manual pulmonary recruitment (5 sec, max 40 cmH2O) is given to the patiënt
Intervention Type
Procedure
Intervention Name(s)
No pulmonary recruitment
Intervention Description
At the end of surgery no intervention was completed
Primary Outcome Measure Information:
Title
pain relief during the first 24 hours
Description
VAS (0-10)
Time Frame
24hours
Secondary Outcome Measure Information:
Title
Total analgesic use during the first 24 hours
Time Frame
24hours
Title
Length of hospital stay
Time Frame
2 days
Title
Recovery after 48 hours
Description
quality of recovery scale
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
AZ groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Casier
Email
isabelle.casier@azgroeninge.be

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain

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