Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery

NCT05995301 | Completed

• 1 other identifier: NAMS Bir Hospital
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 .

Conditions

Analgesia; Ropivacaine; Laparoscopic Abdominal Surgery; Local Infiltration

Keywords

Ropivacaine; TAP Block; Analgesia; Laparoscopic abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  Visual analog scale at rest

  Time Frame: upto first 24 hour after intervention

Secondary Outcomes (1)

• Duration of analgesia

  Time Frame: upto first 24 hour after intervention

Other Outcomes (3)

• Time to first rescue analgesia

  Time Frame: upto first 24 hour after intervention

• Total pethidine consumption

  Time Frame: upto first 24 hour after intervention

• Total ketorolac consumption

  Time Frame: upto first 24 hour after intervention

Study Arms (2)

Group I

EXPERIMENTAL

Transversus Abdominis Plane block

Drug: Ropivacaine in Transversus abdominis plane

Group II

EXPERIMENTAL

Local infiltration

Drug: Ropivacaine in Local infiltration at port site

Interventions

Ropivacaine in Transversus abdominis plane DRUG

This group received 20ml of Ropivacaine 0.2% Injectable Solution in bilateral transversus abdominis plane at the end of surgery

Group I

Ropivacaine in Local infiltration at port site DRUG

This group received local infiltration of 20ml of Ropivacaine 0.2% Injectable Solutionat port sites at the end of surgery

Group II

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients of either sex aged 25-70 years
• ASA physical status I or II
• Patient posted for elective abdominal laparoscopic surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Academy of Medical Sciences, Nepal: lead

Study Sites (1)

National Academy of Medical Sciences

Kathmandu, Bagmati, 977, Nepal

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Surendra Bhusal, MD

  NAMS Bir Hospital

  PRINCIPAL INVESTIGATOR

• Brihaspati K C, MD

  NAMS Bir Hospital

  STUDY DIRECTOR

• Kaushal Tamang, MD

  NAMS Bir Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: March 12, 2022
• Primary Completion: November 12, 2022
• Study Completion: February 25, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

NE (1)