Postoperative Analgesic Efficacy of Trans Abdominis Plane Block

Study Overview
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Brief Summary
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Transverse abdominis plane (TAP) block is an effective method to manage postoperative pain in patients with midline abdominal wall incisions. It is used frequently in many lower abdominal surgeries however its use after caesarean section is still new, and fewer studies are available. We conducted this study to see the analgesic effect of TAP block after caesarean section.

Detailed Description
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The study is being conducted, at Combined Military Hospital Sargodha, Pakistan, to compare the analgesic efficacy of TAP block in providing post-caesarean analgesia with the control group, in terms of mean postoperative use of opioids after caesarean delivery. Sixty patients have been randomly selected using non-probability, consecutive sampling, and applying inclusion and exclusion criteria. The study design is a randomized controlled trial with thirty patients in each group undergoing elective caesareans. All patients will be given spinal anaesthesia with 1.5ml of 0.75% hyperbaric bupivacaine for a caesarean section. Patients in Group A will receive bilateral TAP block with 20ml of 0.25% bupivacaine while 20 ml of saline will be injected in patients of Group B on both sides of midline after caesarean section, in addition to intravenous ketorolac 8hrly. The intensity of pain, total opioid consumption, presence of vomiting, and sedation will be noted until 24 hours after the surgery.

Official Title
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Postoperative Analgesic Efficacy of Trans Abdominis Plane Block in Women Undergoing Caesarean Section, a Randomized Controlled Trial

Conditions
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Post Operative Pain, Cesarean Section Complications

Intervention / Treatment
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* Procedure: Trans abdominis plane block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective Caesarean section ASA 1-3 20yrs to 45yrs Exclusion Criteria: Emergency Surgery known allergy to local anaesthetic severe pre-eclampsia placenta accreta ASA 4 Coagulopathy Hemodynamically unstable

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP block group<br>At the end of the cesarean section, a TAP block will be given by Injecting of 20ml 0.25% Bupivacaine on both sides of the midline using ultrasound-guided subcostal approach | Procedure: Trans abdominis plane block<br>* Ultrasound guided infiltration of local anaesthetic bupivacaine via 22G Quincke needle between internal oblique and trans abdominis muscle layers in abdominal wall.<br>|
| No Intervention: Placebo group<br>At the end of the cesarean section, 20 ml of saline will be injected on both sides of the midline | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | within 24hours after surgery | 24 hours post cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity Score | Pain intensity at 6 hours,12 hours and 24 hours after surgery | from end of secarean section till 24 post operative hours | 
| Vomiting | frequency of vomiting within 24hours after surgery | Within 24hours after surgery | 
| Duration of First Rescue Analgesia | time after surgery when first dose of opioid required | Within 24hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAP block, C-section, Spinal anesthesia, localized field effects, analgesia, Postoperative pain and Opioids