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Clinical Trials/NCT04788654
NCT04788654
Completed
Phase 3

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

Gangnam Severance Hospital1 site in 1 country60 target enrollmentMarch 17, 2021

Overview

Phase
Phase 3
Intervention
Celebrex, acetaminophen, and dexamethasone
Conditions
Laparoscopic Cholecystectomy
Sponsor
Gangnam Severance Hospital
Enrollment
60
Locations
1
Primary Endpoint
Area under curve of postoperative pain for 24 hour
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 17, 2021
End Date
July 31, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Do-Hyeong Kim

Associate professor

Gangnam Severance Hospital

Eligibility Criteria

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

Arms & Interventions

Pharmacological group

Pharmacological analgesia will be performed

Intervention: Celebrex, acetaminophen, and dexamethasone

Pharmacologican and surgical group

Pharmacological and surgical analgesia will be performed.

Intervention: Celebrex, acetaminophen, and dexamethasone

Pharmacologican and surgical group

Pharmacological and surgical analgesia will be performed.

Intervention: Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum

Outcomes

Primary Outcomes

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

  • Analgesic requirements,(At postoperative 24 hour)
  • Postoperative pain score,(At postoperative 0, 2, 6, and 24 hour)
  • Sleep quality(At postoperative 24 hour)

Study Sites (1)

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