Clinical trial NCT05995301: Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery
Official title: Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Ropivacaine
Laparoscopic Abdominal Surgery
Local Infiltration
Keywords: Ropivacaine
TAP Block
Analgesia
Laparoscopic abdominal surgery
Lead sponsor: National Academy of Medical Sciences, Nepal
Sponsor class: OTHER_GOV
First posted: 2023-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Duration of analgesia
timeFrame: Time Frame: upto first 24 hour after intervention
Secondary outcomes:
measure: Duration of analgesia
timeFrame: Time Frame: upto first 24 hour after intervention
Other outcomes:
measure: Time to first rescue analgesia
timeFrame: Time Frame: upto first 24 hour after intervention
measure: Total pethidine consumption
timeFrame: Time Frame: upto first 24 hour after intervention
measure: Total ketorolac consumption
timeFrame: Time Frame: upto first 24 hour after intervention
Locations:
city: Kathmandu
country: Nepal
facility: National Academy of Medical Sciences
state: Bagmati
Study officials:
affiliation: NAMS Bir Hospital
name: Surendra Bhusal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NAMS Bir Hospital
name: Brihaspati K C, MD
role: STUDY_DIRECTOR
affiliation: NAMS Bir Hospital
name: Kaushal Tamang, MD
role: STUDY_CHAIR
References: