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

NCT03433014 | Completed

• 1 other identifier: 2016/200
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Laparoscopic Colorectal Surgery; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• measure pain scores (Visual Analog Scale) in the postoperative period

  After the operation, the inpatient ward nurse will record the patients' pain score at 4 hours after surgery using the VAS score and record the results in the study data recording form attached to each patient's medical record chart.standardized plan for postoperative analgesia is prepared. All patients will receive one 500 mg tablet of oral paracetamol every 6 hours when postoperative oral intake is allowed by the attending doctor. In patients with VAS scores \>3, parenteral opioid (Morphine) is given.

  4 hours after surgery using the VAS score

Secondary Outcomes (1)

• objective is to compare the VAS scores between the two types of technique used for specimen retrieval incision

  4 hours after surgery using the VAS score

Study Arms (2)

0.5% Levobupivacaine

ACTIVE COMPARATOR

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.

Procedure: 0.5% Levobupivacaine

Control

OTHER

The control group will not receive any local infiltrative agent.

Other: Control

Interventions

0.5% Levobupivacaine PROCEDURE

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.

0.5% Levobupivacaine

Control OTHER

No infiltration

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective laparoscopic colorectal surgery under general anesthesia.
• ASA (American Society of Anesthesiologists) classification 1 and 2
• Laparoscopic colorectal surgery including Laparoscopic segmental colonic resection, laparoscopic anterior resection and laparoscopic low anterior resection

You may not qualify if:

• Conversion to open surgery.
• Patients receive epidural anesthesia.
• Patients have history allergy to aminoamides.

Sponsors & Collaborators

• Mahidol University: lead
• Ramathibodi Hospital: collaborator

Study Sites (1)

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Chairat Supsamutchai, MD

  Ramathibodi Hospital, Mahidol University

  STUDY CHAIR

• Chumpon Wilasrusmee, MD

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 control group will not receive any local infiltrative agent.

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 14, 2018
• Study Start: March 31, 2018
• Primary Completion: August 1, 2020
• Study Completion: December 30, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)