Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04609033

Enrollment

110

Registered

2020-10-30

Start date

2020-10-24

Completion date

2021-03-30

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Pain

Brief summary

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

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

Interventions

DRUGBupivacaine

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

DRUGisotonic saline

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

DRUGBupivacaine + morphine

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

DRUGBupivacaine + morphine + ketamine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
VISUUEAL ANALOGE SCORE	24 hours	to assess postoperative pain

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026