Post Operative PainPhase 2NCT06089200
TAP Block vs Spinal Orphine for Postoperative Caesarean Section Analgetics
A Phase 2 study testing Transversus Abdominal Plane Block and Spinal Morphine in people with Post Operative Pain, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
The goal of this randomized controlled trial is to compare the effect of TAP block vs spinal morphine for post caesarean section analgesics. The main questions it aims to answer are: Which post op analgesic method works better for patients who underwent caesarean section The number of additional opioid needed Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Transversus Abdominal Plane Block and Spinal Morphine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Feb 2023to 28 Apr 2023
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Indicated for caesarean section as assessed by Obstetricians
- ASA II
- Consented to be included in the study
Who cannot join
- Allergy history
- Spinal converted to general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Post-operative Analgetics With Transversus Abdominis Block and Spinal Morphine for Post-Caesarean Section: A Randomised Trial Study
The goal of this randomized controlled trial is to compare the effect of TAP block vs spinal morphine for post caesarean section analgesics. The main questions it aims to answer are:
- Which post op analgesic method works better for patients who underwent caesarean section
- The number of additional opioid needed
- Conditions
- Post Operative Pain
- Being tested
- Transversus Abdominal Plane Block, Spinal Morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominal Plane BlockProcedure or surgery
20 cc of bupivacaine 0.2% was given to the transversus abdominis plane
Spinal MorphineProcedure or surgery
100 µg was administered intrathecally preoperatively
| Study group | Role | What they receive |
|---|---|---|
| Transversus Abdominis Plane Block | Experimental | Twenty two subjects were given postoperative block administration in the transversus abdominis area on each side with ultrasonography (USG) guidance Receives: Procedure: Transversus Abdominal Plane Block |
| Spinal Morphine | Active comparator | Twenty two subjects were given additional morphine 100 µg intrathecally Receives: Procedure: Spinal Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time the patient needed the first additional opioid analgesics
Measured: 24 hours post operative
Total need for additional opioids
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start23 Feb 2023
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad F Maulana, MD, Principal investigator, Faculty of Medicine Universitas Padjadjaran BandungSuwarman, MD, Study director, Faculty of Medicine Universitas Padjadjaran BandungOsmond M Pison, MD, Study director, Faculty of Medicine Universitas Padjadjaran BandungPrapanca Nugraha, MD, Study director, Faculty of Medicine Universitas Padjadjaran Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089200
- Sponsor's protocol ID
- AN-202310.01
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Analgetics With Transversus Abdominis Block and Spinal Morphine for Post-Caesarean Section: A Randomised Trial Study
- ClinicalTrials.gov ID
- NCT06089200
- Acronym / sponsor ID
- AN-202310.01
- Conditions
- Post Operative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 18 Oct 2023 (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 goal of this randomized controlled trial is to compare the effect of TAP block vs spinal morphine for post caesarean section analgesics. The main questions it aims to answer are:
- Which post op analgesic method works better for patients who underwent caesarean section
- The number of additional opioid needed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus Abdominis Plane Block | Experimental | Procedure: Transversus Abdominal Plane BlockTwenty two subjects were given postoperative block administration in the transversus abdominis area on each side with ultrasonography (USG) guidance |
| Spinal Morphine | Active comparator | Procedure: Spinal MorphineTwenty two subjects were given additional morphine 100 µg intrathecally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Indicated for caesarean section as assessed by Obstetricians
- ASA II
- Consented to be included in the study
Key exclusion criteria (2 listed)
- Allergy history
- Spinal 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 |
|---|---|---|
| Transversus Abdominal Plane Block20 cc of bupivacaine 0.2% was given to the transversus abdominis plane | Procedure or surgery | Transversus Abdominis Plane Block |
| Spinal Morphine100 µg was administered intrathecally preoperatively | Procedure or surgery | Spinal Morphine |
Primary outcome
Length of time the patient needed the first additional opioid analgesics
Time frame: 24 hours post operative
Total need for additional opioids
Time frame: 24 hours post operative
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 18 Oct 2023.
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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.
Mohammad F Maulana, MD principal investigator
Faculty of Medicine Universitas Padjadjaran Bandung
Suwarman, MD study director
Faculty of Medicine Universitas Padjadjaran Bandung
Osmond M Pison, MD study director
Faculty of Medicine Universitas Padjadjaran Bandung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transversus Abdominal Plane Block and Spinal Morphine in people with Post Operative Pain, run by Universitas Padjadjaran at 1 site in Indonesia.
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 3 inclusion and 2 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 18 Oct 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 Indonesia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Length of time the patient needed the first additional opioid analgesics (time frame: 24 hours post operative). The study lists 2 primary outcomes in all. 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 18 Oct 2023.