Postoperative Pain, Cesarean Section
Conditions
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.
Interventions
DRUGFentanyl HCl
Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia
Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia Ultrasound-guided Transversus Abdominal plane block using Bupivacaine 0.25% Injectable Solution
Sponsors
Nepal Mediciti Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the time to the first rescue analgesics | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
Nepal
Outcome results
None listed