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OpenTrials
Completed

NCT Number: NCT05547659

Multimodal and Unimodal Analgesia in Cholecystectomy

Many surgical procedures are accompanied by postoperative pain with severity moderate, severe or extreme and insufficient postoperative pain control may cause risk of post-surgical complications and risk of chronic post-surgical pain The targets of preoperative pain management are to relieve patient suffering, reduce length of hospital stay and achieve early mobilization after surgery, decreasing opioid consumption and its side effects that are constipation, nausea, vomiting, dizziness, respiratory depression which is the most feared complication being life-threatening and some less common side effects as sedation

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Key information

Conditions

Compare Unimodal and Multimodal Analgesics

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beni suef University hospital, Banī Suwayf, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing laparoscopic cholecystectomy
  • Patients older than 18 years old

Exclusion criteria

  • Renal or hepatic or cardiac impairment patients
  • Patients with chronic pain history
  • Allergic patients after taking aspirin or other NSAIDs
  • patients with active gastrointestinal bleeding, ulcer and inflammatory bowel diseases or cerebrovascular bleeding

Treatment and study plan

Pregabalin 150mg

Drug

Pregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group

Acetaminophen 1 G Oral Tablet

Drug

Acetaminophen 1 G Oral Tablet preoperative in multi-modal group

Celecoxib 400Mg Oral Capsule

Drug

Celecoxib 400Mg Oral Capsule preoperative in multi-modal group

Primary outcomes

  1. Postoperative visual analogue scale (VAS)

    Time frame: 24 hour postoperative

    The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.

  2. Amount of post operative Needed opioid analgesia

    Time frame: 24 hour postoperative

    ampules of opioid analgesia needed after operation

Secondary outcomes

  1. Type and amount of prescribed post operative non opioid analgesia

    Time frame: 24 hour postoperative

    Type and amount of prescribed post operative non opioid analgesia

Other outcomes

  1. Reported opioid side effects

    Time frame: 24 hour postoperative

    Side effects reported after opioid administration eg. nausea, vomiting, respiratory depression etc..

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Collaborators

  • Beni-Suef University

Registry information

Official study title

Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2022
Registry last updated
Sep 21, 2022

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.