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

• Sponsor: National Academy of Medical Sciences, Nepal (Other)
• Overall Status: Completed
• CT.gov ID: NCT05995301
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.5
• Patients Per Site Per Month: 8.7

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Analgesia; Ropivacaine; Laparoscopic Abdominal Surgery; Local Infiltration	Drug: Ropivacaine 0.2% Injectable Solution in Transversus abdominis plane; Drug: Ropivacaine 0.2% Injectable Solution Local infiltration at port site	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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 (Participant, Care 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.
• Primary Purpose: Supportive Care
• Official Title: Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery
• Actual Study Start Date: Mar 12, 2022
• Actual Primary Completion Date: Nov 12, 2022
• Actual Study Completion Date: Feb 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I Group I received bilateral Transversus Abdominis Plane block with Injection Ropivacaine (0.20 %) 20 ml on each side	Drug: Ropivacaine 0.2% Injectable Solution 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 Group II received local infiltration with ropivacaine (0.20%) 20 ml on port sites.	Drug: Ropivacaine 0.2% Injectable Solution 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

Outcome Measures

Primary Outcome Measures

1. Duration of analgesia [Time Frame: upto first 24 hour after intervention]

   Visual analog scale at rest

Secondary Outcome Measures

1. Duration of analgesia [Time Frame: upto first 24 hour after intervention]

   Visual analog scale on movement

Other Outcome Measures

1. Time to first rescue analgesia [Time Frame: upto first 24 hour after intervention]

   The time of first complaint of pain by the patient.

2. Total pethidine consumption [Time Frame: upto first 24 hour after intervention]

   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

3. Total ketorolac consumption [Time Frame: upto first 24 hour after intervention]

   When pain persisted for more than 15 min after giving intravenous pethidine, injection ketorolac 30 mg intravenous was given

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Academy of Medical Sciences	Kathmandu	Bagmati	Nepal	977

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Surendra Bhusal, Principal Investigator, National Academy of Medical Sciences, Nepal
• ClinicalTrials.gov Identifier: NCT05995301
• Other Study ID Numbers: NAMS Bir Hospital
• First Posted: Aug 16, 2023
• Last Update Posted: Aug 16, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Surendra Bhusal, Principal Investigator, National Academy of Medical Sciences, Nepal: Ropivacaine; TAP Block; Analgesia; Laparoscopic abdominal surgery
• Additional relevant MeSH terms: Agnosia; Ropivacaine; Pharmaceutical Solutions

Study Results

No Results Posted as of Aug 16, 2023