The Analgesic Efficacy of Ultrasound Guided Transversus Abdominal Plane Block After Abdominal Cancer Surgeries

Study Overview
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Brief Summary
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Effective postoperative pain control results in decreased cardiac and pulmonary complications, patient satisfaction and early mobilization. A prospective, randomized comparative study was done of analgesic efficacy, opioid requirement and side effects in patients undergoing lower abdominal cancer surgeries. In Study Group Ultrasound guided Transversus Abdominis Plane (TAP) block was given and control Group no TAP block was given. Patient controlled analgesia (PCA) with intravenous morphine was given to both group patients, and total good PCA demands in both the groups was studied.

Detailed Description
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Adult patients of both sexes undergoing major lower abdominal cancer surgeries were enrolled in the study. After obtaining written informed consent from all the patients, they were randomly allotted to either Study (TAP) Group or Control group. Standard general anesthesia with endotracheal intubation was performed in all the patients. Preoperatively all patients received information about Visual Analogue Scale (VAS) for Pain Score from 1 to 10 depending on intensity of pain and about the use of Patient Controlled Analgesia (PCA) Pump. After the end of surgery and before extubation bilateral Ultrasound guided Transversus Abdominis Plane (TAP) block was performed with 16 G Tuohy needle and 18 G Braun Perifix epidural catheter was placed about 6-8 cms in situ. Bupivacaine 0.25 % 20 ml was given bilaterally and repeated 8 hourly in the Postoperative Anaesthesia Care Unit (PACU) for first 24 hours. The PCA Pump was set to deliver bolus Intravenous Morphine 1 milligram ( mg ) with lock out interval 10 minutes. In the PACU heart rate, Non invasive blood pressure, Visual Analogue Score at rest and on knee flexion, Sedation score, nausea and vomiting, any side effects as itching was noted by care provider at 0, 2, 4, 6, 12, 18 and 24 hours. Total and good PCA demands upto 24 hours was recorded.

Official Title
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The Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane (TAP) Block in Lower Abdominal OncoSurgeries

Conditions
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Abdominal Cancer

Intervention / Treatment
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* Drug: Bupivacaine (Transversus Abdominis Plane Block)
* Drug: Intravenous Patient Controlled Analgesia (PCA) Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients belonging to American Society of Anesthesiologist (ASA) Physical Status I to III, for Open lower abdominal major onco surgeries more than 2 hours duration. Exclusion Criteria: Patient refusal to participate in the study, allergy to local anesthetics, coagulopathy, local skin infection at the site of TAP Block.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transversus Abdominis Plane (TAP) Block Group<br>Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly upto 24 hours. | Drug: Bupivacaine (Transversus Abdominis Plane Block)<br>* Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly up to 24 hours.<br>|
| Placebo Comparator: Control Group (No TAP Block)<br>The Transversus Abdominis Plane Block was not performed. Intravenous PCA Morphine was given as rescue analgesic upto 24 hours. | Drug: Intravenous Patient Controlled Analgesia (PCA) Morphine<br>* PCA Intravenous Morphine 1 milligram bolus on demand was given as rescue analgesia up to 24 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Pain Score in PACU in Transversus Abdominis Plane Block and Control Patient Group. | In the PACU Visual Analogue Pain Score will be noted at rest and on knee flexion up to 24 hours. | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total and Good demands for PCA IV Morphine in milligrams in both the groups. | In the PACU, Total and Good PCA IV Morphine demands in milligrams in both groups was studied. | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transverse Abdominis Plane (TAP) Block, Patient Control Analgesia (PCA)