Comparison of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Cesarean Section

Study Overview
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Brief Summary
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Subarachnoid block is a widely used anesthetic technique for cesarean section. To improve the quality of analgesia and prolong its duration, the addition of intrathecal opioids to local anesthetics has been encouraged. In a double blind randomized controlled trial, 60 parturient women ASA 2-3 scheduled for elective cesarean delivery under spinal anesthesia will be randomly divided into 2 groups: Group 1 will receive sufentanil 5 μg and Group 2 will receive meperidine 12.5 mg. In every group, 0.5% heavy bupivacaine 10 will be added.

Detailed Description
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A questionnaire will be used to collect data. Patients' demographic and operative characteristics will be recorded. These include block level, heart rate, mean arterial pressure, nausea, vomiting, shivering and use of vasopressors. Post-operative data include pain, analgesic consumption, nausea and vomiting, as well as patients and surgeons satisfaction.

Official Title
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Comparison of Clinical Effects of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Patients Undergoing Cesarean Section

Conditions
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Analgesia

Intervention / Treatment
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* Drug: sufentanil
* Drug: meperidine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women with American Society of Anesthesiologist (ASA) 2-3 scheduled for elective cesarean section. Exclusion Criteria: refuse to participate in the study, requiring emergency obstetric care, ASA IV or V, having systemic diseases, a known fetal anomaly, placenta previa, abruption placenta with a history of hypersensitivity or allergy to any of the study drugs, operation time longer than 1.5 hour, blood loss more than 1500 millilitres, those with any contraindication to the technique proposed,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sufentanil Group<br>Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia | Drug: sufentanil<br>* Patients will receive sufentanil in spinal anesthesia<br>Drug: Bupivacaine<br>* Patients will receive 0.5% heavy bupivacaine in spinal anesthesia<br>|
| Experimental: Meperidine Group<br>Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia | Drug: meperidine<br>* Patients will receive meperidine in spinal anesthesia<br>Drug: Bupivacaine<br>* Patients will receive 0.5% heavy bupivacaine in spinal anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First analgesic request time | The duration of effective analgesia is defined as the time from intrathecal injection to first patient analgesic demand | 24 hours post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic requirements | A questionnaire will be used to record the analgesics consumed by the patients | 24 hours post operatively |