An interventional study of Fentanyl HCl and Bupivacaine 0.25% Injectable Solution in Postoperative Pain and Cesarean Section, sponsored by Nepal Mediciti Hospital. Completed at 1 site in Nepal. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Nepal Mediciti Hospital · Not applicable, Interventional, and Treatment
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 93 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Nepal Mediciti Hospital is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intrathecal additive Fentanyl with hyperbaric bupivacaine
Drug: Fentanyl HCl
The intrathecal additive of fentanyl with hyperbaric bupivacaine along with Ultrasound-guided TAP block
Drug: Fentanyl HCl · Drug: Bupivacaine 0.25% Injectable Solution
Hyperbaric bupivacaine along with Ultrasound-guided TAP block without the intrathecal addition of fentanyl
Drug: Bupivacaine 0.25% Injectable Solution
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
Also known as: Intrathecal Fentanyl
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 frame: Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours
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 frame: Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2022 to primary completion in Feb 2023, 6 months.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 6 months is below that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fentanyl hydrochloride · Bupivacaine
Nepal Mediciti Hospital