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OpenTrials
Completed

NCT Number: NCT06535256

Compare Intraperitoneal Instillation of Bupivacaine+dexmedetomidine Versus Bupivacaine+dexamethasone on Postoperative Pain After Lap Cholecystectomy

Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zaher

Cairo, Egypt

About this study

Laparoscopy has become the preferred mode for many diagnostic and operative procedures. It has the advantage better cosmetic results, faster recovery, short post-operative hospital stays, and early resumption of normal activities. Post-laparoscopic pain results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity is very annoying to the patients.

Although the severity of pain after a laparoscopic procedure is less compared to laparotomy, but it is acute and can lead to increased analgesic requirements and prolonged hospital stays.

Several studies have evaluated post-laparoscopic pain relief methods such as intravenous analgesics analgesic patches, steroids, and intra-peritoneal instillation of local anaesthetics alone or with additives.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients scheduled for laparoscopic cholecystectomy
  • Age 18-60 years
  • American Society of Anesthesiologists (ASA) physical status I-II

Exclusion criteria

  • Patients with diabetes mellitus
  • Allergy to the study drugs
  • Patients on steroids
  • Pregnant females
  • Patients with cardiac, pulmonary, hepatic or renal disorders

Treatment and study plan

bupivacaine with dexamethasone

Combination Product

intra-peritoneal instillation of bupivacaine with dexamethasone (received 40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline).

bupivacaine with dexmedetomidine

Combination Product

intra-peritoneal instillation of bupivacaine with dexmedetomidine (received 40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml).

Primary outcomes

  1. incidence and severity of postoperative pain for 24 hours

    Time frame: severity of postoperative pain measured at 1, 2, 4, 8, 16, and 24 hours. postoperatively, using Visual Analogue Scale

    using VAS pain score

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

Comparison of Intraperitoneal Instillation of Bupivacaine with Dexmedetomidine Versus Bupivacaine with Dexamethasone on Postoperative Pain After Laparoscopic Cholecystectomy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2024
Registry last updated
Mar 11, 2025

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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