Intrathecal Levobupivacaine With Opioids for Caesarean Section

Summary

In this prospective, randomized, double-blind, controlled study, the aim was to compare the effect of adding fentanyl (10 µg) or sufentanil (2.5 µg) to levobupivacaine (2.2±0.2 ml 0.5%) on the intraoperative anesthesia quality, block characteristics, the side effects on the newborn and mother, the duration of postoperative analgesia, and surgeon satisfaction score.

Conditions

• Elective Caesarean Section Surgeries

Interventions

DRUG

Control Group Chirocaine

Control group: Spinal anesthesia with levobupivacaine+Serum Physiologic %0.9 (Total volume 3 mL)

DRUG

Group Fentanyl

DRUG

Group sufentanil

DRUG

Ephedrine

If systolic blood pressure values decreased more than 20% with respect to the baseline values, or decreased to \<100 mmHg, fluid loading and ephedrine (5 mg) were administered.

DRUG

Atropine sulfate

A decrease in heart rate to less than 55 beats/min was considered as bradycardia, and atropine (0.5 mg) was administered

DRUG

Propofol

Intravenous propofol (up to 0.5 mg/kg) was administered if patients had discomfort

DRUG

Metoclopramide

Metoclopramide (10 mg IV) was administered for nausea

DRUG

Diphenhydramine

for severe pruritus

DRUG

pethidine hydrochloride

pethidine hydrochloride (50 mg IM) was administered as the first analgesic postoperatively

DRUG

Diclofenac sodium

as additional analgesic among cases in which VAS\>3(Postoperatively)

Sponsors & Collaborators

• Baskent University

  lead OTHER

Principal Investigators

• Anis Aribogan, Prof., MD · Baskent University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2009-10-31

Completion

2010-01-31

Countries

• Turkey (Türkiye)

Study Locations