Clinical trial NCT05550597: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Cesarean Section
Lead sponsor: Nepal Mediciti Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To compare the time to the first rescue analgesics
timeFrame: Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours
Secondary outcomes:
measure: Percentage of participants with treatment related side effects like pruritus, nausea and vomiting.
timeFrame: Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours
Other outcomes:
Locations:
city: Lalitpur
country: Nepal
facility: Nepal Mediciti Hospital
Study officials:
affiliation: Nepal Mediciti Hospital
name: Bijay Rayamajhi, FCPS
role: PRINCIPAL_INVESTIGATOR
References: