Multimodal Analgesia for Cholecystectomy

Phase 3

Completed

• Conditions: Laparoscopic Cholecystectomy
• Interventions: Drug: Celebrex, acetaminophen, and dexamethasone; Procedure: Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum

• Registration Number: NCT04788654
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-03-07
• Study First Posted: 2021-03-09
• Study Start: 2021-03-17
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacological group	Celebrex, acetaminophen, and dexamethasone	Pharmacological analgesia will be performed
Pharmacologican and surgical group	Celebrex, acetaminophen, and dexamethasone	Pharmacological and surgical analgesia will be performed.
Pharmacologican and surgical group	Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum	Pharmacological and surgical analgesia will be performed.

Primary Outcome Measures

Name	Time	Method
Area under curve of postoperative pain for 24 hour	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 Outcome Measures

Name	Time	Method
Analgesic requirements,	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.
Postoperative pain score,	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).
Sleep quality	At postoperative 24 hour	Sleep quality will be measured using sleep quality questionnare at postoperative 24 hour.; using sleep quality questionnare.

Trial Locations

Locations (1)

Do-Hyeong Kim; 🇰🇷 Seoul, Korea, Republic of