Comparison of the Time to the First Rescue Analgesic Among Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
The postoperative pain management after cesarean section under spinal anestheisa is done using various modalities. The commonly used regimens are systemic NSAIDs/Opioids, USG guided TAP block or Intrathecal additive Fentanyl or combined intrathecal fentanyl and USG guided TAP block. Investigators aim to compare the postoperative analgesia in terms of time to the first rescue analgesic in parturients receiving intrathecal additive fentanyl only, or intrathecal fentanyl with USG guided TAP block or USG guided TAP block alone for elective CS done under hyperbaric bupivacaine spinal anesthesia.

Detailed Description
-----------------
Investigators will enroll 93 parturients planned for elective CS under hyperbaric bupivacaine spinal anesthesia and allocate them into three groups comprising intrathecal additive fentanyl only, or intrathecal fentanyl with USG guided TAP block or USG guided TAP block alone. The primary outcome will be time to the first rescue analgesics.

Official Title
-----------------
Comparison of the Time to the First Rescue Analgesic Among Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia

Conditions
-----------------
Postoperative Pain, Cesarean Section

Intervention / Treatment
-----------------
* Drug: Fentanyl HCl
* Drug: Bupivacaine 0.25% Injectable Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiology(ASA) physical status II Able to read and understand the information sheet and to sign and date the consent form Scheduled for elective CS planned with Spinal anesthesia Gestational age > 37 weeks and < weeks assessed on the dating scale. Exclusion Criteria: Complicated pregnancy; defined as having preeclampsia or placenta accreta,increta and percreta Opioid addiction or dependence Contraindications to TAP block( Ski infection, abdominal wall muscle defects) Allergy to any medications used in the study Case converted to General Anesthesia Cases who develop postoperative hemorrhage, amniotic fluid embolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group F<br>The intrathecal additive Fentanyl with hyperbaric bupivacaine | Drug: Fentanyl HCl<br>* Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia<br>|
| Experimental: Group FT<br>The intrathecal additive of fentanyl with hyperbaric bupivacaine along with Ultrasound-guided TAP block | Drug: Fentanyl HCl<br>* Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia<br>Drug: Bupivacaine 0.25% Injectable Solution<br>* Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia Ultrasound-guided Transversus Abdominal plane block using Bupivacaine 0.25% Injectable Solution<br>* Other names: Intrathecal Fentanyl;|
| Experimental: Group T<br>Hyperbaric bupivacaine along with Ultrasound-guided TAP block without the intrathecal addition of fentanyl | Drug: Bupivacaine 0.25% Injectable Solution<br>* Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia Ultrasound-guided Transversus Abdominal plane block using Bupivacaine 0.25% Injectable Solution<br>* Other names: Intrathecal Fentanyl;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the time to the first rescue analgesics | The time from the arrival to Postoperative care Unit to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 among the Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia | Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with treatment related side effects like pruritus, nausea and vomiting. | To compare the side effects like pruritus, nausea and vomiting Among Parturients among the Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia | Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours |