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NCT04997174 Clinical Trial

Comparison of Postoperative Pain Management in Patients Undergoing Laparoscopic Colorectal Surgery Under Enhanced Recovery After Surgery (ERAS) Program, Laparoscopic Colorectal Surgery Without ERAS and Open Colorectal Surgery

Postoperative Pain Clinical Trial

Official title:
Comparison of Postoperative Pain Management in Patients Undergoing Laparoscopic Colorectal Surgery Under Enhanced Recovery After Surgery (ERAS) Program, Laparoscopic Colorectal Surgery Without ERAS and Open Colorectal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04997174
Other study ID # REC.64-290-8-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2021
Est. completion date December 2022

Study information
Verified date October 2021
Source Prince of Songkla University
Contact Sasikaan Nimmaanrat, MD
Phone +66887907842
Email snimmaanrat@yahoo.com.au
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective study to compare postoperative pain intensity in patients going laparoscopic colorectal surgery with Enhanced Recovery after Surgery (ERAS), without ERAS and open colorectal surgery.

Description:

This study is a matched case-control study. Control patients will be matched to ERAS cases in a 1:1:1 ratio (laparoscopic surgery with ERAS protocol : laparoscopic surgery without ERAS protocol : open surgery).

Recruitment information / eligibility
Status Recruiting
Enrollment 162
Est. completion date December 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients undergoing colorectal surgery under ERAS program and those with the same sort of laparoscopic surgery without ERAS program as well as those with open colorectal surgery with complete required recorded data. Exclusion Criteria: - 1. Patients with incomplete required data on record. - 2. Those with any major intraoperative or postoperative complications.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Celecoxib
Patients in ERAS group received celecoxib

Locations
Country Name City State
Thailand Sasikaan Nimmaanrat Hat Yai Songkhla

Sponsors (1)
Lead Sponsor Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Tan SJ, Zhou F, Yui WK, Chen QY, Lin ZL, Hu RY, Gao T, Li N. Fast track programmes vs. traditional care in laparoscopic colorectal surgery: a meta-analysis of randomized controlled trials. Hepatogastroenterology. 2014 Jan-Feb;61(129):79-84. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pain intensity Pain score (Verbal Numerical Rating Scale: VNRS) after surgery, VNRS consists of 0-10, where 0 means no pain and 10 means worst pain imaginable Until discharge (5-7 days)
Secondary Opioid Amount of postoperative opioid consumption Until discharge (5-7 days)
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