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

Not Applicable

Completed

• Conditions: Analgesia; Ropivacaine; Laparoscopic Abdominal Surgery; Local Infiltration
• Interventions: Drug: Ropivacaine in Local infiltration at port site; Drug: Ropivacaine in Transversus abdominis plane

• Registration Number: NCT05995301
• Lead Sponsor: National Academy of Medical Sciences, Nepal

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

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 Timeline

• Study Start: 2022-03-12
• Primary Completion: 2022-11-12
• Study Completion: 2023-02-25
• Status Verified: 2023-08
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-16
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Ropivacaine in Local infiltration at port site	Local infiltration
Group I	Ropivacaine in Transversus abdominis plane	Transversus Abdominis Plane block

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	Time Frame: upto first 24 hour after intervention	Visual analog scale at rest

Secondary Outcome Measures

Name	Time	Method
Duration of analgesia	Time Frame: upto first 24 hour after intervention	Visual analog scale on movement

Trial Locations

Locations (1)

National Academy of Medical Sciences; 🇳🇵 Kathmandu, Bagmati, Nepal