Perineal PainPhase 4NCT03694873
Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia
A Phase 4 study testing Tramadol Hydrochloride and Celecoxib 200mg in people with Perineal Pain, run by Cairo University.
Trial summary
This trial will be performed to compare the effectiveness of oral tramadol versus oral celecoxib for the management of perineal pain following episiotomy or perineal tear repair after spontaneous vaginal birth in obese women Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Pain
- What is being tested?
- Tramadol Hydrochloride and Celecoxib 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2018to 10 Dec 2018
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age:18-35 years
- Obese women with BMI ≥ 30.
- completed full 37-weeks gestation.
- spontaneous vaginal delivery with medio-lateral episiotomy or perineal tear requiring repair.
- Singleton alive fetus.
Who cannot join
- known allergy to investigated drugs(tramadol or celecoxib).
- regular use of analgesic drugs before or during pregnancy.
- any medical condition known to be potentially exacerbated by opioids, including alimentary canal disorders, hepatic and renal disease.
- instrumental vaginal delivery.
- 3rd or 4th degree perineal tear.
- severe postpartum haemorrhage (>1,500 ml).
Show all 9Show fewer
- complicating maternal diseases (pregestational/gestational diabetes mellitus; bleeding disorders; pre-eclampsia and other hypertensive disorders of pregnancy).
- epidural nor combined spinal-epidural analgesia in labour
- a history of peptic ulcer,asthma,thrombocytopaenia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia After Spontaneous Vaginal Birth in Obese Women: A Randomised Controlled Trial
This trial will be performed to compare the effectiveness of oral tramadol versus oral celecoxib for the management of perineal pain following episiotomy or perineal tear repair after spontaneous vaginal birth in obese women
Read the detailed description
Pain after episiotomy or tear of perineal tissues during childbirth is often inadequately treated and may be severe. Not only did perineal pain negatively affect the physical and mental functioning of the woman, but also it might decrease the success of breastfeeding and reduced her ability to care for her child. The methods of relieving perineal pain included medication and non-medication. When the perineal pain was mild, the most common analgesic used was acetaminophen. Whereas the perineal pain was more severe, other drugs had been chosen such as opioid, non-opioid, and a combination of both opioid and non-opioid analgesics
- Conditions
- Perineal Pain
- Being tested
- Tramadol Hydrochloride, Celecoxib 200mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HydrochlorideDrug
one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.
Celecoxib 200mgDrug
Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally immediately, 12 h and 24 h after randomization.
| Study group | Role | What they receive |
|---|---|---|
| tramadol | Experimental | one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization. Receives: Drug: Tramadol Hydrochloride |
| celecoxib | Active comparator | one tablet of Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally immediately, 12 h and 24 h after randomization. Receives: Drug: Celecoxib 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
perineal pain
perineal pain severity using visual analogue scale
Measured: 1 hour after repair of episiotomy
Secondary outcomes (1)
perineal pain
perineal pain severity using visual analogue scale
Measured: 1 hours after repair of episiotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start10 Oct 2018 (estimated)
- Primary completion5 Dec 2018 (estimated)
- Study completion10 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694873
- Sponsor's protocol ID
- perineal pain
- Status last verified
- Oct 2018
- First submitted
- 2 Oct 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia After Spontaneous Vaginal Birth in Obese Women: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03694873
- Acronym / sponsor ID
- perineal pain
- Conditions
- Perineal Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2018 (estimated)
- Primary completion
- 5 Dec 2018 (estimated)
- Study completion
- 10 Dec 2018 (estimated)
- First posted
- 3 Oct 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.
This trial will be performed to compare the effectiveness of oral tramadol versus oral celecoxib for the management of perineal pain following episiotomy or perineal tear repair after spontaneous vaginal birth in obese women
Detailed description
Pain after episiotomy or tear of perineal tissues during childbirth is often inadequately treated and may be severe. Not only did perineal pain negatively affect the physical and mental functioning of the woman, but also it might decrease the success of breastfeeding and reduced her ability to care for her child. The methods of relieving perineal pain included medication and non-medication. When the perineal pain was mild, the most common analgesic used was acetaminophen. Whereas the perineal pain was more severe, other drugs had been chosen such as opioid, non-opioid, and a combination of both opioid and non-opioid analgesics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tramadol | Experimental | Drug: Tramadol Hydrochlorideone tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization. |
| celecoxib | Active comparator | Drug: Celecoxib 200mgone tablet of Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally immediately, 12 h and 24 h after randomization. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age:18-35 years
- Obese women with BMI ≥ 30.
- completed full 37-weeks gestation.
- spontaneous vaginal delivery with medio-lateral episiotomy or perineal tear requiring repair.
- Singleton alive fetus.
Key exclusion criteria (9 listed)
- known allergy to investigated drugs(tramadol or celecoxib).
- regular use of analgesic drugs before or during pregnancy.
- any medical condition known to be potentially exacerbated by opioids, including alimentary canal disorders, hepatic and renal disease.
- instrumental vaginal delivery.
- 3rd or 4th degree perineal tear.
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 |
|---|---|---|
| Tramadol Hydrochlorideone tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization. | Drug | tramadol |
| Celecoxib 200mgCelecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally immediately, 12 h and 24 h after randomization. | Drug | celecoxib |
Primary outcome
perineal pain
Time frame: 1 hour after repair of episiotomy
perineal pain severity using visual analogue scale
1 secondary outcome
perineal pain
Time frame: 1 hours after repair of episiotomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
Related trials for Perineal Pain
Not yet recruiting
Pudendal Nerve Block for Pain Relief During Episiotomy Repair
Episiotomy , Perineal Pain
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Active, not recruiting
Pudendal Nerve Block With Articaine and Triamcinolone for Pudendal Neuralgia
Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic Pain
Not yet recruiting
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal Trauma, Postpartum Pain
Not yet recruiting
Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing in Postpartum Women
Episiotomy, Platelet Rich Plasma (PRP)
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.
AHMED SAMY, MD principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol Hydrochloride and Celecoxib 200mg in people with Perineal Pain, run by Cairo University.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AHMED SAMY, MD (01100681167, ahmedsamy8233@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perineal pain (time frame: 1 hour after repair of episiotomy). 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 3 Oct 2018.