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

September 1, 2021 updated by: Mahidol University

A Prospective Randomized Controlled Trial of Postoperative Analgesic Effects of Local Wound Infiltration With 0.5% Levobupivacaine in Laparoscopic Colorectal Surgery.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bankok
      • Bangkok, Bankok, Thailand, 10400
        • Chairat Supsamutchai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
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
The control group will not receive any local infiltrative agent.
Other: Control
No infiltration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
measure pain scores (Visual Analog Scale) in the postoperative period
Time Frame: 4 hours after surgery using the VAS score
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
objective is to compare the VAS scores between the two types of technique used for specimen retrieval incision
Time Frame: 4 hours after surgery using the VAS score
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.
4 hours after surgery using the VAS score

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ramathibodi Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Chairat Supsamutchai, MD, Ramathibodi Hospital, Mahidol University
  • Principal Investigator: Chumpon Wilasrusmee, MD, Faculty of Medicine Ramathibodi Hospital, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016/200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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