Different Epidural Initiation Volumes

Effects of Different Epidural Initiation Volumes on Postoperative Analgesia in Cesarean Delivery

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: 5 mL epidural initiation volume (bupivacaine + fentanyl); Drug: 10 mL epidural initiation volume (bupivacaine + fentanyl); Drug: 20 mL epidural initiation volume (bupivacaine + fentanyl)

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey
    • Inonu University Turgut Ozal Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 5; 5 mL epidural initiation volume (bupivacaine + fentanyl)	Drug: 5 mL epidural initiation volume (bupivacaine + fentanyl); 5 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter; Other Names: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)
Active Comparator: Group 10; 10 mL epidural initiation volume (bupivacaine + fentanyl)	Drug: 10 mL epidural initiation volume (bupivacaine + fentanyl); 10 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter; Other Names: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)
Active Comparator: Group 20; 20 mL epidural initiation volume (bupivacaine + fentanyl)	Drug: 20 mL epidural initiation volume (bupivacaine + fentanyl); 20 mL 0.625% bupivacaine + + 2 μg/mL fentanyl solution is administered from epidural catheter; Other Names: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postoperative pain scores	Visual analog scale	up to 12 hours after cesarean delivery

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects associated with epidural analgesia	Nausea-vomiting, itching, motor block, hypotension	up to 12 hours after cesarean delivery

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Study Chair: Mahmut Durmus, Prof, Prof Dr

Publications and helpful links

General Publications

• Sng BL, Woo D, Leong WL, Wang H, Assam PN, Sia AT. Comparison of computer-integrated patient-controlled epidural analgesia with no initial basal infusion versus moderate basal infusion for labor and delivery: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2014 Oct;30(4):496-501. doi: 10.4103/0970-9185.142842.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: cesarean section; postoperative pain; combined spinal epidural anesthesia; patient controlled epidural analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: Inonu Anesthesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No