Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

Study Overview
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Brief Summary
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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
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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

Official Title
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Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia After Spontaneous Vaginal Birth in Obese Women: A Randomised Controlled Trial

Conditions
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Perineal Pain

Intervention / Treatment
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* Drug: Tramadol Hydrochloride
* Drug: Celecoxib 200mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tramadol<br>one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization. | Drug: Tramadol Hydrochloride<br>* one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.<br>|
| Active Comparator: celecoxib<br>one tablet of Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally immediately, 12 h and 24 h after randomization. | Drug: Celecoxib 200mg<br>* Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally immediately, 12 h and 24 h after randomization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perineal pain | perineal pain severity using visual analogue scale | 1 hour after repair of episiotomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perineal pain | perineal pain severity using visual analogue scale | 1 hours after repair of episiotomy |