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OpenTrials
Completed

NCT Number: NCT04788654

Multimodal Analgesia for Cholecystectomy

It is important to decrease the postoperative pain in patients undergoing laparoscopic cholecystectomy. We will compare the pharmacologic analgesia with the parmacologic and surgical analgesia in patients undergoing laparoscopic cholecystectomy.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Do-Hyeong Kim

Seoul, seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective laparoscopic cholecystectomy

Exclusion criteria

  • Recent gastric ulcer disease
  • Hepatic or renal insufficiency
  • Opioid dependency
  • Coagulopathy
  • Pre-existing neurologic or anatomic deficits in the lower extremities
  • Severe psychiatric illness
  • pregnancy

Treatment and study plan

Celebrex, acetaminophen, and dexamethasone

Drug

Pharmacological intervention will be performed. Celebrex 200mg, acetaminophen 1g, and dexamethasone 7 mg will be infused perioperatively.

Other names: Pharmacological

Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum

Procedure

Surgical intervention will be performed. Saline irrigation, aspiration of pneumoperitoneum, and low pressure pneumoperitoneum will be performed.

Other names: Surgical

Primary outcomes

  1. Area under curve of postoperative pain for 24 hour

    Time frame: At postoperative 24 hour

    Area under curve will be measured using Postoperative pain score at postoperative 24 hour using visual anlogue scale (0: no pain, 10: most imaginable pain).

Secondary outcomes

  1. Postoperative pain score,

    Time frame: At postoperative 0, 2, 6, and 24 hour

    Postoperative pain score: postoperative pain score will be measured at postoperative 0, 2, 6, and 24 hour using visual anlogue scale (0: no pain, 10: most imaginable pain).

  2. Analgesic requirements,

    Time frame: At postoperative 24 hour

    Analgesic requirements will be measured at postoperative 24 hour. Total dose of tramadol, ketorolac, and pethidine will be assessed at postoperative 24 hour.

  3. Sleep quality

    Time frame: At postoperative 24 hour

    Sleep quality will be measured using sleep quality questionnare at postoperative 24 hour.

    using sleep quality questionnare.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

The Comparison of Multimodal Analgesic Protocols for Laparoscopic Cholecystectomy: Pharmacologic Interventions and Combination of Pharmacologic and Operative Interventions

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2021
Registry last updated
Oct 6, 2023

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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