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

Makassed General Hospital

Status: Unknown

Conditions: Analgesia

Treatments: Drug: sufentanil; Drug: Bupivacaine; Drug: meperidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04446715

17062020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Sufentanil Group

Experimental group

Description:

Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia

Treatment:

Drug: Bupivacaine

Drug: sufentanil

Meperidine Group

Experimental group

Description:

Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia

Treatment:

Drug: meperidine

Drug: Bupivacaine