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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Analgesia, Ropivacaine, Laparoscopic Abdominal Surgery, Local Infiltration

Intervention / Treatment
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* Drug: Ropivacaine in Transversus abdominis plane
* Drug: Ropivacaine in Local infiltration at port site


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ropivacaine, TAP Block, Analgesia, Laparoscopic abdominal surgery