Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

August 27, 2021 updated by: Esam Hamed, Assiut University
Postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The incidence of pain after laparoscopy may be as high as 36 to 63 percent and is attributed to the carbon dioxide gas (CO2) used to induce pneumo-peritoneum1.

The residual part of CO2 remains in the peritoneal cavity for several days after the operation and causes stretching of the phrenic nerve endings, local hypothermia, and diaphragmatic irritation by carbonic acid formation

Study Type

Interventional

Enrollment (Actual)

110

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

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut university hospitals

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

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for Laparoscopic cholecystectomy.
  • Age spectrum of 18 - 55 years
  • ASA I, II
  • Have no comorbid chronic medical diseases

Exclusion Criteria:

  • Patients with co morbid medical diseases
  • Age outside the specified range
  • Acute inflammation of the gall bladder
  • Critically ill patient
  • Emergency operations
  • Patient refusal

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: bupivacaine group
Drug: Bupivacaine
instillation of local anaesthetic in the abdominal cavity at the end of the procedure
ACTIVE_COMPARATOR: bupivacaine + morphine
Drug: Bupivacaine + morphine
instillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure
ACTIVE_COMPARATOR: bupivacaine + morphine + ketamine
Drug: Bupivacaine + morphine + ketamine
instillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure
PLACEBO_COMPARATOR: isotonic saline
Drug: isotonic saline
instillation of local anaesthetic in the abdominal cavity at the end of the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative level of ACTH hormone
Time Frame: 6 hours
a stress marker that increase with pain and surgery
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VISUUEAL ANALOGE SCORE
Time Frame: 24 hours
to assess postoperative pain
24 hours

Collaborators and Investigators

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

Sponsor

Assiut University

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)

October 24, 2020

Primary Completion (ACTUAL)

March 1, 2021

Study Completion (ACTUAL)

March 30, 2021

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

October 23, 2020

First Posted (ACTUAL)

October 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17300477

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.

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