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Local Wound Infiltration With 0.5% Levobupivacaine for Postoperative Pain After Laparoscopic Colorectal Surgery.

NCT03433014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-09-02

No results posted yet for this study

Summary

The study design is a prospective randomized, double-blind, controlled trial of patients who are due to have elective laparoscopic colorectal surgery in Ramathibodhi Hospital. The primary objective is to measure pain scores (Visual Analog Scale) in the postoperative period. The secondary objective is to compare the VAS scores between the two types of technique used for specimen retrieval incision.After approval by the ethics committee, patients scheduled for elective laparoscopic colorectal surgery under general anesthesia who are eligible for inclusion criteria were recruited for this study after informed consent by surgical residents or surgical staff at the Outpatient Department (OPD). Patients who meet the exclusion criteria will be excluded.

Conditions

Interventions

PROCEDURE

0.5% Levobupivacaine

The infiltration group will receive local infiltration with 0.5% Levobupivacaine. The trocar insertion sites are infiltrated before the skin incision is made. Using the Lap-Assist Transversus Abdominis Plane Block Technique, the total volume of infiltrated 0.5% Levobupivacaine is 20 ml, divided proportionally according to the length of the skin incision (2 ml for the 5-mm trocar and 3 ml for the 10-mm trocars, and 10 mL for specimen retrieval incision). The specimen retrieval incision will be performed in one of two techniques, depending on the surgeon's preference, a 4-6 cm length midline incision (extending from the Hasson trocar incision) or a 4-6 cm length Pfanensteil incision.

OTHER

Control

No infiltration

Sponsors & Collaborators

  • Ramathibodi Hospital

    collaborator OTHER

  • Mahidol University

    lead OTHER

Principal Investigators

  • Chairat Supsamutchai, MD · Ramathibodi Hospital, Mahidol University

  • Chumpon Wilasrusmee, MD · Ramathibodi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-31
Primary Completion
2020-08-01
Completion
2020-12-30

Countries

  • Thailand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03433014 on ClinicalTrials.gov