Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-24

Study Completion Date

2021-03-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Perioperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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bupivacaine group

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

instillation of local anaesthetic in the abdominal cavity at the end of the procedure

bupivacaine + morphine

Group Type ACTIVE_COMPARATOR

Bupivacaine + morphine

Intervention Type DRUG

instillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure

bupivacaine + morphine + ketamine

Group Type ACTIVE_COMPARATOR

Bupivacaine + morphine + ketamine

Intervention Type DRUG

instillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure

isotonic saline

Group Type PLACEBO_COMPARATOR

isotonic saline

Intervention Type DRUG

instillation of local anaesthetic in the abdominal cavity at the end of the procedure

Interventions

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Bupivacaine

instillation of local anaesthetic in the abdominal cavity at the end of the procedure

Intervention Type DRUG

isotonic saline

instillation of local anaesthetic in the abdominal cavity at the end of the procedure

Intervention Type DRUG

Bupivacaine + morphine

instillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure

Intervention Type DRUG

Bupivacaine + morphine + ketamine

instillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No