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
Overview
- Phase
- Not Applicable
- Intervention
- Fentanyl HCl
- Conditions
- Postoperative Pain
- Sponsor
- Nepal Mediciti Hospital
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- To compare the time to the first rescue analgesics
- Status
- Completed
- Last Updated
- 3 years ago
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.
Investigators
Bijay Rayamajhi
Anesthesia Resident
Nepal Mediciti Hospital
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
Arms & Interventions
Group F
The intrathecal additive Fentanyl with hyperbaric bupivacaine
Intervention: Fentanyl HCl
Group FT
The intrathecal additive of fentanyl with hyperbaric bupivacaine along with Ultrasound-guided TAP block
Intervention: Fentanyl HCl
Group FT
The intrathecal additive of fentanyl with hyperbaric bupivacaine along with Ultrasound-guided TAP block
Intervention: Bupivacaine 0.25% Injectable Solution
Group T
Hyperbaric bupivacaine along with Ultrasound-guided TAP block without the intrathecal addition of fentanyl
Intervention: Bupivacaine 0.25% Injectable Solution
Outcomes
Primary Outcomes
To compare the time to the first rescue analgesics
Time Frame: Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours
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
Secondary Outcomes
- Percentage of participants with treatment related side effects like pruritus, nausea and vomiting.(Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours)