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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04446715
• Other study ID #: 17062020
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: August 2021

Study information

• Verified date: July 2021
• Source: Makassed General Hospital
• Contact: Saleh Kanawati, MD
• Phone: +9611636000
• Email: s.kanawati[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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,

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• sufentanil
Patients will receive sufentanil in spinal anesthesia
• meperidine
Patients will receive meperidine in spinal anesthesia
• Bupivacaine
Patients will receive 0.5% heavy bupivacaine in spinal anesthesia

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analgesic requirements	A questionnaire will be used to record the analgesics consumed by the patients	24 hours post operatively