- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03433014
Local Wound Infiltration With 0.5% Levobupivacaine for Postoperative Pain After Laparoscopic Colorectal Surgery.
A Prospective Randomized Controlled Trial of Postoperative Analgesic Effects of Local Wound Infiltration With 0.5% Levobupivacaine in Laparoscopic Colorectal Surgery.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bankok
-
Bangkok, Bankok, Thailand, 10400
- Chairat Supsamutchai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
No infiltration
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Collaborators
Investigators
- Study Chair: Chairat Supsamutchai, MD, Ramathibodi Hospital, Mahidol University
- Principal Investigator: Chumpon Wilasrusmee, MD, Faculty of Medicine Ramathibodi Hospital, Mahidol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Levobupivacaine
Other Study ID Numbers
- 2016/200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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