Cesarean DeliveryPhase 4NCT03039426
Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine
A Phase 4 study testing Bupivacaine and Diclofenac in people with Cesarean Delivery, run by Department of Medical Services Ministry of Public Health of Thailand at 2 sites in Thailand.
Trial summary
This randomized controlled trial, compared postoperative pain score in patient undergoing cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac intramuscular injection Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- Bupivacaine and Diclofenac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Jan 2017to 30 Dec 2017
- Phase
- Phase 4
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergo elective or urgency cesarean delivery at Rajavithi Hospital in 2016-2017
- Urgency conditions: CPD, fail induction of labor, antepartum hemorrhage without hypovolemic shock, dystocia, previous cesarean section and active labor, malpresentation in labor, macrosomic presentation in labor
- Pregnant women more than 20 years of age
- Gestational age more than 37 week
- Cesarean section under regional or general anesthesia
- Ability to communicating, writing and reading Thai language
Who cannot join
- Inability to communicating or writing or reading Thai language
- Contraindicated to bupivacaine or diclofenac or morphine
- Pregnant women with emergency conditions
- Have one or more complication of pregnancy
- Intraoperative arrhythmia
- Pregnant women less than 20 years of age
- Regional anesthesia with morphine
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Natthida Mekwongtrakarn
Bangkok, 10400
Rajavithi Hospital
Bangkok
About this study
Official title: A Randomized Comparison of Bupivacaine Peritoneal and Subcutaneous Infiltration Versus Diclofenac Intramuscular Injection for Postoperative Pain Relief in Patient Undergoing Cesarean Delivery
This randomized controlled trial, compared postoperative pain score in patient undergoing cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac intramuscular injection
Read the detailed description
Postoperative cesarean delivery was painful that can effect daily activity, resulted in poor quality of life and required morphine injection to relief pain which had both maternal and breastfeeding infancy side effect. So this study compare efficacy of diclofenac and bupivacaine by measured the pain score and requirement of morphine injection.
- Conditions
- Cesarean Delivery
- Being tested
- Bupivacaine, Diclofenac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration
DiclofenacDrug
diclofenac 75 mg intramuscular, 2 hours postoperation
| Study group | Role | What they receive |
|---|---|---|
| Group Bupivacaine | Experimental | 0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration Receives: Drug: Bupivacaine |
| Group Diclofenac | Active comparator | diclofenac 75 mg intramuscular, 2 hours postoperation Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared pain score change from baseline at 2, 6 and 24 hours at post-operation between 2 groups by visual analogue scale
Measured: 2, 6 and 24 hours post-operation
Compared rescued dose of morphine injection
Measured: Within 24 hours post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Jan 2017
- Primary completion30 Jun 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039426
- Sponsor's protocol ID
- RJBUPI
- Status last verified
- Oct 2017
- First submitted
- 28 Sep 2016
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Bupivacaine Peritoneal and Subcutaneous Infiltration Versus Diclofenac Intramuscular Injection for Postoperative Pain Relief in Patient Undergoing Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03039426
- Acronym / sponsor ID
- RJBUPI
- Conditions
- Cesarean Delivery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 1 Feb 2017 (estimated)
- 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.
This randomized controlled trial, compared postoperative pain score in patient undergoing cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac intramuscular injection
Detailed description
Postoperative cesarean delivery was painful that can effect daily activity, resulted in poor quality of life and required morphine injection to relief pain which had both maternal and breastfeeding infancy side effect. So this study compare efficacy of diclofenac and bupivacaine by measured the pain score and requirement of morphine injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Bupivacaine | Experimental | Drug: Bupivacaine0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration |
| Group Diclofenac | Active comparator | Drug: Diclofenacdiclofenac 75 mg intramuscular, 2 hours postoperation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients undergo elective or urgency cesarean delivery at Rajavithi Hospital in 2016-2017
- Pregnant women more than 20 years of age
- Gestational age more than 37 week
- Cesarean section under regional or general anesthesia
- Ability to communicating, writing and reading Thai language
Key exclusion criteria (7 listed)
- Inability to communicating or writing or reading Thai language
- Contraindicated to bupivacaine or diclofenac or morphine
- Pregnant women with emergency conditions
- Have one or more complication of pregnancy
- Intraoperative arrhythmia
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 |
|---|---|---|
| Bupivacaine0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration | Drug | Group Bupivacaine |
| Diclofenacdiclofenac 75 mg intramuscular, 2 hours postoperation | Drug | Group Diclofenac |
Primary outcome
Compared pain score change from baseline at 2, 6 and 24 hours at post-operation between 2 groups by visual analogue scale
Time frame: 2, 6 and 24 hours post-operation
Compared rescued dose of morphine injection
Time frame: Within 24 hours post-operation
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 22 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Cesarean Delivery
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine and Diclofenac in people with Cesarean Delivery, run by Department of Medical Services Ministry of Public Health of Thailand at 2 sites in Thailand.
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 6 inclusion and 7 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Compared pain score change from baseline at 2, 6 and 24 hours at post-operation between 2 groups by visual analogue scale (time frame: 2, 6 and 24 hours post-operation). 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 22 Oct 2020.