Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy

September 3, 2022 updated by: Hanan Ibrahim Mansour, University of Jordan

Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial

The purpose of this study is to assess the effect of low-pressure pneumoperitoneum on post operative pain and inflammation in patients undergoing elective laparoscopic cholecystectomy by comparing it to standard practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After obtaining informed consent from eligible study participants. patients were randomized into one of two masked groups, labelled red and green. The red-label group was operated at standard-pressure pneumoperitoneum, while the green-label group was operated at low-pressure pneumoperitoneum. Baseline blood samples were obtained pre-operatively for ten inflammatory markers, patients' demographics and intra-operative details collected, then post-operative pain and change in inflammatory markers were followed.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
    • Jubaiha
      • Amman, Jubaiha, Jordan, 13046
        • Jordan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Elective admission for laparoscopic cholecystectomy

Exclusion Criteria:

  • Current or previous diagnosis of acute cholecystitis confirmed by ultrasound
  • previous GI surgeries, except bariatric and anti-reflux surgeries
  • Currently on immunosuppressant agents
  • Pregnancy
  • Breastfeeding
  • Currently diagnosed with drug addiction
  • American Society of Anesthesiologists (ASA) score 3 and more

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-pressure pneumoperitoneum
Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg
Procedure: low-pressure pneumoperitoneum
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
Active Comparator: Standard-pressure pneumoperitoneum
Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg
Procedure: standard-pressure pneumoperitoneum
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of pain with SPS-11 at 6hr post-op
Time Frame: pre-op to 6 hours post op

measure difference in pain on the 11-point short pain scale (SPS-11) at 6-hour post-op compared to baseline at pre-op, minimum score of 0 , maximun score of 10

= pain at 6 hour post op - pain at pre-op
pre-op to 6 hours post op
change in IL-6
Time Frame: pre op to 24 hours post -op

measure differance of inflammatory marker from baseline

= baseline value- post op value (calculated in pg/mL) post-op collected at 24 hours from end of surgery
pre op to 24 hours post -op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of difficulty of surgery
Time Frame: start to end of the study, 1 year

to measure difference in surgery difficulty between the two groups using a scale of 1; easy, 2; moderate, 3; difficult.

analysis done using Chi-square cross table on SPSS V 1.0.0.1406
start to end of the study, 1 year
assessment of difference in operation time
Time Frame: start to end of the study, 1 year

to look for difference in operation time between the two groups, calculated in minutes.

analysis done using Student's 2-tailed t-test on SPSS V 1.0.0.1406
start to end of the study, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

January 30, 2021

Study Completion (Actual)

January 30, 2021

Study Registration Dates

First Submitted

August 27, 2022

First Submitted That Met QC Criteria

September 3, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 3, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/2019/1115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on low-pressure pneumoperitoneum

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe