Postoperative PainNCT05550597
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
A study testing Fentanyl HCl and Bupivacaine 0.25% Injectable Solution in people with Postoperative Pain and Cesarean Section, run by Nepal Mediciti Hospital at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain, Cesarean Section
- What is being tested?
- Fentanyl HCl and Bupivacaine 0.25% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteNepal
- Study dates
- 15 Aug 2022to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Postoperative Pain, Cesarean Section
- Being tested
- Fentanyl HCl, Bupivacaine 0.25% Injectable Solution
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl HClDrug
Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia
Bupivacaine 0.25% Injectable SolutionDrug
Also called Intrathecal Fentanyl
Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia Ultrasound-guided Transversus Abdominal plane block using Bupivacaine 0.25% Injectable Solution
| Study group | Role | What they receive |
|---|---|---|
| Group F | Experimental | The intrathecal additive Fentanyl with hyperbaric bupivacaine Receives: Drug: Fentanyl HCl |
| Group FT | Experimental | The intrathecal additive of fentanyl with hyperbaric bupivacaine along with Ultrasound-guided TAP block Receives: Drug: Fentanyl HCl; Drug: Bupivacaine 0.25% Injectable Solution |
| Group T | Experimental | Hyperbaric bupivacaine along with Ultrasound-guided TAP block without the intrathecal addition of fentanyl Receives: Drug: Bupivacaine 0.25% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours
Secondary outcomes (1)
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
Measured: Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start15 Aug 2022
- Primary completion20 Feb 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nepal Mediciti Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bijay Rayamajhi, Nepal Mediciti Hospital
- Investigators
- Bijay Rayamajhi, FCPS, Principal investigator, Nepal Mediciti Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550597
- Sponsor's protocol ID
- 2022
- Status last verified
- Mar 2023
- First submitted
- 13 Sep 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05550597
- Acronym / sponsor ID
- 2022
- Conditions
- Postoperative Pain, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Nepal Mediciti HospitalUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group F | Experimental | Drug: Fentanyl HClThe intrathecal additive Fentanyl with hyperbaric bupivacaine |
| Group FT | Experimental | Drug: Fentanyl HCl, Drug: Bupivacaine 0.25% Injectable SolutionThe intrathecal additive of fentanyl with hyperbaric bupivacaine along with Ultrasound-guided TAP block |
| Group T | Experimental | Drug: Bupivacaine 0.25% Injectable SolutionHyperbaric bupivacaine along with Ultrasound-guided TAP block without the intrathecal addition of fentanyl |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl HClIntrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia | Drug | Group F, Group FT |
| Bupivacaine 0.25% Injectable SolutionAlso: Intrathecal FentanylIntrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia Ultrasound-guided Transversus Abdominal plane block using Bupivacaine 0.25% Injectable Solution | Drug | Group FT, Group T |
Primary outcome
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
1 secondary outcome
Percentage of participants with treatment related side effects like pruritus, nausea and vomiting.
Time frame: Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bijay Rayamajhi, FCPS principal investigator
Nepal Mediciti Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl HCl and Bupivacaine 0.25% Injectable Solution in people with Postoperative Pain and Cesarean Section, run by Nepal Mediciti Hospital at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.