Multimodal Analgesia for Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04788654
• Other study ID #: 3-2020-0494
• Status: Completed
• Phase: Phase 3
• Start date: March 17, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: October 2023
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 31, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

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

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.

Locations

Country	Name	City	State
Korea, Republic of	Do-Hyeong Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under curve of postoperative pain for 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	Postoperative pain score,	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
Secondary	Analgesic requirements,	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
Secondary	Sleep quality	Sleep quality will be measured using sleep quality questionnare at postoperative 24 hour.; using sleep quality questionnare.	At postoperative 24 hour