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

Primary Purpose

Laparoscopic Colorectal Surgery, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
0.5% Levobupivacaine
Control
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Laparoscopic Colorectal Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Chairat Supsamutchai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

0.5% Levobupivacaine

Control

Arm Description

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.

The control group will not receive any local infiltrative agent.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 31, 2018
Last Updated
September 1, 2021
Sponsor
Mahidol University
Collaborators
Ramathibodi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03433014
Brief Title
Local Wound Infiltration With 0.5% Levobupivacaine for Postoperative Pain After Laparoscopic Colorectal Surgery.
Official Title
A Prospective Randomized Controlled Trial of Postoperative Analgesic Effects of Local Wound Infiltration With 0.5% Levobupivacaine in Laparoscopic Colorectal Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 31, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
Ramathibodi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
During a preoperative visit, the patients are introduced to the concept of the visual analogue scale (VAS), which ranges from 0 = no pain to 10 = worst pain. Once given general anesthesia in the operating room, the patient will be randomly selected into one of the two arms of this report's diagram (1:1 ratio) through the drawing of a sealed, opaque envelope by one of the surgical residents in charge or by the attending surgeon. 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.After induction, the pneumoperitoneum will be created via the Open Hasson Technique and using a 10-12-mm trocar. During surgery, intraabdominal pressure is maintained at 12-15 mmHg. In addition to the Hasson trocar, one 10-mm and two to three 5-mm trocars will be used. 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. A 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. The hospital volunteer nurses caring for the patients during the preoperative and postoperative course are given standard pain evaluation protocols. All study pain evaluators and patients are blinded to treatment assignments throughout the pain assessment process. 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. Additional morphine usage data is also recorded. All side effects, such as tinnitus, nausea, vomiting, headache, dizziness, seizure, cardiovascular instability, and local wound complication will be recorded and treated by the attending resident or consultant doctor. All data is collected by the main investigator from the patient chart and data recording form. Data is expressed as mean ± SD. Parametric data is compared between groups. Statistical significance is set at a level of p< 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Colorectal Surgery, Colorectal Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5% Levobupivacaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
The control group will not receive any local infiltrative agent.
Intervention Type
Procedure
Intervention Name(s)
0.5% Levobupivacaine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No infiltration
Primary Outcome Measure Information:
Title
measure pain scores (Visual Analog Scale) in the postoperative period
Description
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.
Time Frame
4 hours after surgery using the VAS score
Secondary Outcome Measure Information:
Title
objective is to compare the VAS scores between the two types of technique used for specimen retrieval incision
Description
The secondary objective is to compare the VAS scores between the two types of technique used 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.
Time Frame
4 hours after surgery using the VAS score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Conversion to open surgery. Patients receive epidural anesthesia. Patients have history allergy to aminoamides.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chairat Supsamutchai, MD
Organizational Affiliation
Ramathibodi Hospital, Mahidol University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chumpon Wilasrusmee, MD
Organizational Affiliation
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chairat Supsamutchai
City
Bangkok
State/Province
Bankok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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

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