Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery
Primary Purpose
Analgesia, Ropivacaine, Laparoscopic Abdominal Surgery
Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Ropivacaine in Transversus abdominis plane
Ropivacaine in Local infiltration at port site
Sponsored by
About this trial
This is an interventional supportive care trial for Analgesia focused on measuring Ropivacaine, TAP Block, Analgesia, Laparoscopic abdominal surgery
Eligibility Criteria
Inclusion Criteria: Adult patients of either sex aged 25-70 years ASA physical status I or II Patient posted for elective abdominal laparoscopic surgery. Exclusion Criteria: Any absolute contraindications to peripheral nerve blockade History of Hypersensitivity to Drugs Uncontrolled Diabetes Mellitus, Renal Failure, Hepatic failure History of neuromuscular or psychiatric disease Patient receiving psychotropic drug, chronic analgesic therapy Pregnancy Patient weight less than 50 kg
Sites / Locations
- National Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group I
Group II
Arm Description
Transversus Abdominis Plane block
Local infiltration
Outcomes
Primary Outcome Measures
Duration of analgesia
Visual analog scale at rest
Secondary Outcome Measures
Duration of analgesia
Visual analog scale on movement
Full Information
NCT ID
NCT05995301
First Posted
August 9, 2023
Last Updated
August 24, 2023
Sponsor
National Academy of Medical Sciences, Nepal
1. Study Identification
Unique Protocol Identification Number
NCT05995301
Brief Title
Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery
Official Title
Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 12, 2022 (Actual)
Primary Completion Date
November 12, 2022 (Actual)
Study Completion Date
February 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Academy of Medical Sciences, Nepal
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 goal of this clinical trial is to compare the postoperative analgesic efficacy of ultrasound-guided TAP block with Local Anesthetic Infiltration of ropivacaine in patients undergoing laparoscopic surgery. The main question it aims to answer is:
• If Transversus Abdominis Plane block with Ropivacaine will produce long duration of analgesia than the Local Anesthetic Infiltration with ropivacaine after laparoscopic abdominal surgery .
Detailed Description
Pain is a natural phenomenon. Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Pain is distressing and detrimental in post-operative patients. Management of post-operative pain has been a challenge to anesthetists. Pain treatment increase speed of recovery, minimum patient suffering, decrease length of stay, reduced hospital costs, increased patient satisfaction, increase productivity and quality of life.
Peripheral nerve blockade or field block with local anesthesia is helpful in managing postoperative pain effectively whilst avoiding complication associated with intravenous narcotics or neuraxial blockade. Regional block will help in reduction of dose and frequency of intravenous narcotics used in postoperative period, hence minimizing the side effects of narcotics.
Ultrasound guided abdominal nerve blocks are increasingly being used for anaesthesia and analgesia. The Transversus Abdominis Plane (TAP) block is a peripheral nerve block that results in anesthesia of the abdominal wall. This plane represents an anatomical potential space with nerves leaving the plane to innervate the abdominal muscles and skin. Transversus abdominis plane block (TAP block) is a novel procedure to provide postoperative analgesia following laparoscopic surgery.
Ropivacaine has a greater degree of motor sensory differentiation. Ropivacaine has been safely used up to the dose of 200 mg (100 ml of 0.2% ropivacaine) as a field block for post operative analgesia. We are giving a larger volume of ropivacaine (20 ml on each side) expecting to cover the upper abdomen when TAP block is performed via posterior approach.
NULL HYPOTHESIS There is no difference in post operative analgesia with Transversus Abdominis Plane block and local anesthetic infiltration after laparoscopicabdominal surgery
General objective
1. To compare the efficacy of Transversus Abdominal plane block and local anesthetic infiltration after laparoscopic abdominal surgery
Specific objective
To compare the visual analog score (VAS) between two groups
To compare time to first analgesic requirement between two groups.
To compare the total dose of analgesia in 24 hours between the two groups
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Ropivacaine, Laparoscopic Abdominal Surgery, Local Infiltration
Keywords
Ropivacaine, TAP Block, Analgesia, Laparoscopic abdominal surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomly assigned to two groups having 50patients in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesia assistant who was not involved in the study.
Masking
ParticipantCare Provider
Masking Description
Patients were randomly assigned to two groups having 50patients in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesia assistant who was not involved in the study.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
Transversus Abdominis Plane block
Arm Title
Group II
Arm Type
Experimental
Arm Description
Local infiltration
Intervention Type
Drug
Intervention Name(s)
Ropivacaine in Transversus abdominis plane
Intervention Description
This group received 20ml of Ropivacaine 0.2% Injectable Solution in bilateral transversus abdominis plane at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Ropivacaine in Local infiltration at port site
Intervention Description
This group received local infiltration of 20ml of Ropivacaine 0.2% Injectable Solutionat port sites at the end of surgery
Primary Outcome Measure Information:
Title
Duration of analgesia
Description
Visual analog scale at rest
Time Frame
Time Frame: upto first 24 hour after intervention
Secondary Outcome Measure Information:
Title
Duration of analgesia
Description
Visual analog scale on movement
Time Frame
Time Frame: upto first 24 hour after intervention
Other Pre-specified Outcome Measures:
Title
Time to first rescue analgesia
Description
The time of first complaint of pain by the patient.
Time Frame
Time Frame: upto first 24 hour after intervention
Title
Total pethidine consumption
Description
At any point of time when VAS was>3, injection pethidine 0.5 mg/kg and injection promethazine 0.25 mg/kg was given via intravenous route
Time Frame
Time Frame: upto first 24 hour after intervention
Title
Total ketorolac consumption
Description
When pain persisted for more than 15 min after giving intravenous pethidine, injection ketorolac 30 mg intravenous was given
Time Frame
Time Frame: upto first 24 hour after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients of either sex aged 25-70 years
ASA physical status I or II
Patient posted for elective abdominal laparoscopic surgery.
Exclusion Criteria:
Any absolute contraindications to peripheral nerve blockade
History of Hypersensitivity to Drugs
Uncontrolled Diabetes Mellitus, Renal Failure, Hepatic failure
History of neuromuscular or psychiatric disease
Patient receiving psychotropic drug, chronic analgesic therapy
Pregnancy
Patient weight less than 50 kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surendra Bhusal, MD
Organizational Affiliation
NAMS Bir Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brihaspati K C, MD
Organizational Affiliation
NAMS Bir Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kaushal Tamang, MD
Organizational Affiliation
NAMS Bir Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
National Academy of Medical Sciences
City
Kathmandu
State/Province
Bagmati
ZIP/Postal Code
977
Country
Nepal
12. IPD Sharing Statement
Learn more about this trial
Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery
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