Obstetric PainTAPNCT03634111
The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section
A study testing TAP block, Morphine and Ropivacaine in people with Obstetric Pain, run by Gia Dinh People Hospital at 1 site in Vietnam.
Trial summary
The transversus abdominis plane block (TAP block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Pain
- What is being tested?
- TAP block, Morphine and Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Jul 2017to 31 Mar 2018
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cesarean section with general anesthesia.
- The ASA classification was from II to III
Who cannot join
- The acute fetal impairment.
- The severe live or renal failure.
- Tolerance opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Transversus Abdominis Plane Block
The transversus abdominis plane block (TAP block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia. The hypothesis that this technique has effect to postoperative analgesia for cesarean section with general anesthesia and it could reduce 50% of total morphine consumption during 24 hours after surgery.
Read the detailed description
This is a randomized, controlled, no-blind clinical trial. The investigators selected 60 cases, who were cesarean section under general anesthesia, age from18 years, and American Society Anesthesiologists (ASA) classification was from II-III. The cases of acute fetal impairment, local anesthesia contraindication, tolerance opioids, liver failure, renal failure, and spinal anesthesia failure were excluded. All cases were randomized assigned two groups: the TAP block group (T group) and controlled group (C group). Each group has 30 cases. The TAP block was performed under the ultrasound guidance with 0.25% of ropivacaine 20 ml each side. The both groups was treated postoperative analgesia with intravenous morphine to patients controlled analgesia (PCA). The primary outcome was total morphine consumption during 24 hours after surgery. The secondary outcomes were the time of required the first dose of morphine, pain score, the complications of TAP block, the side effects of morphine, and satisfaction score of participants. Data was described and analyzed with SPSS 25.0. The sample size was calculated with the hypothesis that TAP block could reduce 50% of dose morphine during 24 hours after surgery, 80% of power, 10% of loss, and 0.05 of alpha error.
- Conditions
- Obstetric Pain
- Being tested
- TAP block, Morphine, Ropivacaine
- Keywords
- transversus abdominis plane block (TAP block), postoperative analgesia, cesarean section
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
Also called Transversus abdominis plane block
TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.
MorphineDrug
Also called Opioids
Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.
RopivacaineDrug
Also called Anaropin
Ropivacaine 0.25% 20 ml each side
| Study group | Role | What they receive |
|---|---|---|
| T group | Active comparator | The TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery. Receives: Procedure: TAP block; Drug: Morphine; Drug: Ropivacaine |
| C group | Placebo comparator | The controlled group was called C group. The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia Receives: Drug: Morphine; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption during 24 hours
Morphine was intravenous perfusion to participants during 24 hours with patients controlled analgesia (PCA).
Measured: 24 hours
Secondary outcomes (5)
The time required the first of dose of morphine (hours)
The time was from the end of surgery to the participants required the first of dose of morphine with PCA.
Measured: 24 hours
Pain score: VAS
Pain score was measured with visual analogue scale (VAS). VAS is from 0 to 10. The zero is complete non-pain and the ten is severe pain
Measured: 24 hours
The rate of complications of TAP block
There were rate of systemic toxicity, puncture peritonea, and hematomae in abdominal wall
Measured: 24 hours
The rate of side effect of morphine
There were rate of sedation, respiratory failure, nause and vomiting, pruritus
Measured: 24 hours
The satisfaction of participants: Likert
It was evaluated with Linkert score. Likerk score is from 1 to 5: 1-strongly disagree, 2-disagree, 3-neither agree nor disagree, 4-agree, 5-strongly agree
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start10 Jul 2017
- Primary completion15 Jul 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Transversus abdominis plane block under the ultrasound guidance
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gia Dinh People Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- THANG T Nguyen, Mr, Principal investigator, Gia Dinh People Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634111
- Sponsor's protocol ID
- 11-2017/CN-HĐĐĐ
- Acronym
- TAP
- Status last verified
- Aug 2018
- First submitted
- 12 Aug 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transversus Abdominis Plane Block
- ClinicalTrials.gov ID
- NCT03634111
- Acronym / sponsor ID
- TAP / 11-2017/CN-HĐĐĐ
- Conditions
- Obstetric Pain
- Keywords
- transversus abdominis plane block (TAP block), postoperative analgesia, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gia Dinh People HospitalUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 16 Aug 2018 (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 transversus abdominis plane block (TAP block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia. The hypothesis that this technique has effect to postoperative analgesia for cesarean section with general anesthesia and it could reduce 50% of total morphine consumption during 24 hours after surgery.
Detailed description
This is a randomized, controlled, no-blind clinical trial. The investigators selected 60 cases, who were cesarean section under general anesthesia, age from18 years, and American Society Anesthesiologists (ASA) classification was from II-III. The cases of acute fetal impairment, local anesthesia contraindication, tolerance opioids, liver failure, renal failure, and spinal anesthesia failure were excluded. All cases were randomized assigned two groups: the TAP block group (T group) and controlled group (C group). Each group has 30 cases. The TAP block was performed under the ultrasound guidance with 0.25% of ropivacaine 20 ml each side. The both groups was treated postoperative analgesia with intravenous morphine to patients controlled analgesia (PCA). The primary outcome was total morphine consumption during 24 hours after surgery. The secondary outcomes were the time of required the first dose of morphine, pain score, the complications of TAP block, the side effects of morphine, and satisfaction score of participants. Data was described and analyzed with SPSS 25.0. The sample size was calculated with the hypothesis that TAP block could reduce 50% of dose morphine during 24 hours after surgery, 80% of power, 10% of loss, and 0.05 of alpha error.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Transversus abdominis plane block under the ultrasound guidance
| Arm | Type | Receives |
|---|---|---|
| T group | Active comparator | Procedure: TAP block, Drug: Morphine, Drug: RopivacaineThe TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery. |
| C group | Placebo comparator | Drug: Morphine, Drug: RopivacaineThe controlled group was called C group. The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Cesarean section with general anesthesia.
- The ASA classification was from II to III
Key exclusion criteria (3 listed)
- The acute fetal impairment.
- The severe live or renal failure.
- Tolerance opioids
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 |
|---|---|---|
| TAP blockAlso: Transversus abdominis plane blockTAP block was performed under guidance with 0.25% ropivacaine 20 ml each side. | Procedure or surgery | T group |
| MorphineAlso: OpioidsSingle dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ. | Drug | C group, T group |
| RopivacaineAlso: AnaropinRopivacaine 0.25% 20 ml each side | Drug | C group, T group |
Primary outcome
Total morphine consumption during 24 hours
Time frame: 24 hours
Morphine was intravenous perfusion to participants during 24 hours with patients controlled analgesia (PCA).
5 secondary outcomes
The time required the first of dose of morphine (hours)
Time frame: 24 hours
Pain score: VAS
Time frame: 24 hours
The rate of complications of TAP block
Time frame: 24 hours
The rate of side effect of morphine
Time frame: 24 hours
The satisfaction of participants: Likert
Time frame: 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 16 Aug 2018.
- 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.
THANG T Nguyen, Mr principal investigator
Gia Dinh People 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 TAP block, Morphine and Ropivacaine in people with Obstetric Pain, run by Gia Dinh People Hospital at 1 site in Vietnam.
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 2 inclusion and 3 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 16 Aug 2018. 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 Vietnam. 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. Some participants in this study may receive a placebo. 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?
Total morphine consumption during 24 hours (time frame: 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 16 Aug 2018.