Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief

Study Overview
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Brief Summary
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The aim of this study is to compare between the effect of wound infiltration with bupivacaine or pethidine for post cesarean section pain relief.

Official Title
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Subrectal and Subcutaneous Wound Infiltration With Bupivacaine Versus Pethidine for Postcesarean Section Pain Relief: a Randomized Clinical Trial

Conditions
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Obstetric Pain

Intervention / Treatment
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* Drug: Wound infiltration by Bupivacaine
* Drug: Wound infiltration by Pethidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mode of delivery: Cesarean section. Gestational age: 37-40 weeks. Type of anaesthesia: Spinal anaesthesia. No past history of any medical disorder or other medical complications during pregnancy. Exclusion Criteria: Women with known hypersensitivity to bupivacaine or pethidine. Women delivered vaginally. Women delivered under general anaesthesia. Women with known neurological or psychological disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Participants will be randomized to local infiltration of cesarean section wound with either bupivacaine or pethidine; with follow up of postoperative pain relief.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine Group<br>Patients delivered by cesarean section followed by wound infiltration by bupivacaine. | Drug: Wound infiltration by Bupivacaine<br>* Subcutaneous and subrectal infiltration with 0.25 % Bupivacaine diluted in 20 ml normal saline before closure of the wound<br>|
| Active Comparator: Pethidine Group<br>Patients delivered by cesarean section followed by wound infiltration by pethidine. | Drug: Wound infiltration by Pethidine<br>* Subcutaneous and subrectal infiltration with 50 mg pethidine diluted in 20 ml normal saline before closure of the wound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative wound pain: VAS | Postoperative wound pain will be assessed using visual analogous scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Mean values will be calculated and compared between the three groups | first 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of opioid drugs needed | Total dose of extra opioid drugs needed to achieve postoperative analgesia | first 24 hours postoperatively | 
| Incidence of nausea and vomiting | Number of patients experiencing nausea and vomiting | first 24 hours postoperatively | 
| Incidence of urine retention | Number of patients experiencing urinary retention | first 24 hours postoperatively | 
| Incidence of hypotension | Number of patients experiencing hypotension | first 24 hours postoperatively |