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

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 .

Study Overview

• Status: Completed
• Conditions: Analgesia; Local Infiltration; Ropivacaine; Laparoscopic Abdominal Surgery
• Intervention / Treatment: Drug: Ropivacaine in Transversus abdominis plane; Drug: Ropivacaine in Local infiltration at port site

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

1. To compare the visual analog score (VAS) between two groups
2. To compare time to first analgesic requirement between two groups.
3. To compare the total dose of analgesia in 24 hours between the two groups

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal, 977
      • National Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Any absolute contraindications to peripheral nerve blockade
2. History of Hypersensitivity to Drugs
3. Uncontrolled Diabetes Mellitus, Renal Failure, Hepatic failure
4. History of neuromuscular or psychiatric disease
5. Patient receiving psychotropic drug, chronic analgesic therapy
6. Pregnancy
7. Patient weight less than 50 kg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Transversus Abdominis Plane block	Drug: Ropivacaine in Transversus abdominis plane; This group received 20ml of Ropivacaine 0.2% Injectable Solution in bilateral transversus abdominis plane at the end of surgery
Experimental: Group II; Local infiltration	Drug: Ropivacaine in Local infiltration at port site; This group received local infiltration of 20ml of Ropivacaine 0.2% Injectable Solutionat port sites at the end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia	Visual analog scale at rest	Time Frame: upto first 24 hour after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia	Visual analog scale on movement	Time Frame: upto first 24 hour after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue analgesia	The time of first complaint of pain by the patient.	Time Frame: upto first 24 hour after intervention
Total pethidine consumption	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: upto first 24 hour after intervention
Total ketorolac consumption	When pain persisted for more than 15 min after giving intravenous pethidine, injection ketorolac 30 mg intravenous was given	Time Frame: upto first 24 hour after intervention

Collaborators and Investigators

• Sponsor: National Academy of Medical Sciences, Nepal
• Investigators: Principal Investigator: Surendra Bhusal, MD, NAMS Bir Hospital; Study Director: Brihaspati K C, MD, NAMS Bir Hospital; Study Chair: Kaushal Tamang, MD, NAMS Bir Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2022
• Primary Completion (Actual): November 12, 2022
• Study Completion (Actual): February 25, 2023

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Analgesia; Ropivacaine; TAP Block; Laparoscopic abdominal surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: NAMS Bir Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No