Multimodal Analgesia for Cholecystectomy

October 4, 2023 updated by: Do-Hyeong Kim, Gangnam Severance Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  1. Recent gastric ulcer disease
  2. Hepatic or renal insufficiency
  3. Opioid dependency
  4. Coagulopathy
  5. Pre-existing neurologic or anatomic deficits in the lower extremities
  6. Severe psychiatric illness
  7. pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pharmacological group
Pharmacological analgesia will be performed
Drug: Celebrex, acetaminophen, and dexamethasone
Pharmacological intervention will be performed. Celebrex 200mg, acetaminophen 1g, and dexamethasone 7 mg will be infused perioperatively.
Other Names:
  • Pharmacological
Experimental: Pharmacologican and surgical group
Pharmacological and surgical analgesia will be performed.
Drug: Celebrex, acetaminophen, and dexamethasone
Pharmacological intervention will be performed. Celebrex 200mg, acetaminophen 1g, and dexamethasone 7 mg will be infused perioperatively.
Other Names:
  • Pharmacological
Procedure: Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum
Surgical intervention will be performed. Saline irrigation, aspiration of pneumoperitoneum, and low pressure pneumoperitoneum will be performed.
Other Names:
  • Surgical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At postoperative 24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At postoperative 0, 2, 6, and 24 hour
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.
At postoperative 24 hour
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.
At postoperative 24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

March 7, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2020-0494

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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