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OpenTrials
Completed

NCT Number: NCT04609033

Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

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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Key information

Conditions

Perioperative Pain

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospitals

Asyut, 71515, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

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

Isotonic saline

Drug

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

Bupivacaine + morphine

Drug

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

Bupivacaine + morphine + ketamine

Drug

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

Primary outcomes

  1. postoperative level of ACTH hormone

    Time frame: 6 hours

    a stress marker that increase with pain and surgery

Secondary outcomes

  1. VISUUEAL ANALOGE SCORE

    Time frame: 24 hours

    to assess postoperative pain

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2020
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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