Different Epidural Initiation Volumes

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: 10 mL epidural initiation volume (bupivacaine + fentanyl); Drug: 5 mL epidural initiation volume (bupivacaine + fentanyl); Drug: 20 mL epidural initiation volume (bupivacaine + fentanyl)

• Registration Number: NCT03156322
• Lead Sponsor: Inonu University

Brief Summary

The aim of this study is to compare the effect of different epidural initiation volumes on postoperative pain scores, local anesthetic requirements, and motor block in patients who undergo patient controlled epidural analgesia for postoperative pain after cesarean section.

Detailed Description

90 minutes after combined epidural spinal catheter insertion, three different volumes (5 mL, 10 mL, and 20 mL) are administered with a patient-controlled epidural analgesia (PCEA) device through the epidural catheter. For each group, 0.625% bupivacain + 2 μg/mL fentanyl, is administered.

The visual analog scale, first analgesic demand time, the number of PCEA requirement per hour, morphine requirement, nausea-vomiting, itching, motor block, hypotension, and total consumed analgesic, and ephedrine amounts of the patients are recorded in the recovery room and at postoperative 2, 4, 6, 12 hours.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-12-01
• Study Completion: 2017-01-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-16
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

Inclusion Criteria

• American Society of Anesthesiology risks classification II
• Term pregnant

Exclusion Criteria

• Multiple pregnancy
• Diabetes mellitus
• Hypertension
• Coagulopathy
• Severe cardiac, neurological and pulmonary disease
• Allergy to the study drugs
• Difficulty in understanding the use of the patient controlled analgesia device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 10	10 mL epidural initiation volume (bupivacaine + fentanyl)	10 mL epidural initiation volume (bupivacaine + fentanyl)
Group 5	5 mL epidural initiation volume (bupivacaine + fentanyl)	5 mL epidural initiation volume (bupivacaine + fentanyl)
Group 20	20 mL epidural initiation volume (bupivacaine + fentanyl)	20 mL epidural initiation volume (bupivacaine + fentanyl)

Primary Outcome Measures

Name	Time	Method
Change in postoperative pain scores	up to 12 hours after cesarean delivery	Visual analog scale

Secondary Outcome Measures

Name	Time	Method
First analgesic demand time	up to 12 hours after cesarean delivery	Time to first analgesic requirement (first patient controlled epidural analgesic demand time)
The number of analgesic requirement	up to 12 hours after cesarean delivery	The number of patient controlled epidural analgesic requirement per hour
Morphine requirement	up to 12 hours after cesarean delivery	Intravenous morphine administration

Trial Locations

Locations (1)

Inonu University Turgut Ozal Medical Center; 🇹🇷 Malatya, Turkey