Different Epidural Initiation Volumes

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156322
• Other study ID #: Inonu Anesthesia
• Status: Completed
• Phase: N/A
• First received: May 9, 2017
• Last updated: May 16, 2017
• Start date: January 1, 2016
• Est. completion date: January 1, 2017

Study information

• Verified date: May 2017
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 1, 2017
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• 5 mL epidural initiation volume (bupivacaine + fentanyl)
5 mL 0.625% bupivacaine + 2 µg/mL fentanyl solution is administered from epidural catheter
• 10 mL epidural initiation volume (bupivacaine + fentanyl)
10 mL 0.625% bupivacaine + 2 µg/mL fentanyl solution is administered from epidural catheter
• 20 mL epidural initiation volume (bupivacaine + fentanyl)
20 mL 0.625% bupivacaine + + 2 µg/mL fentanyl solution is administered from epidural catheter

Locations

Country	Name	City	State
Turkey	Inonu University Turgut Ozal Medical Center	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects associated with epidural analgesia	Nausea-vomiting, itching, motor block, hypotension	up to 12 hours after cesarean delivery
Primary	Change in postoperative pain scores	Visual analog scale	up to 12 hours after cesarean delivery
Secondary	First analgesic demand time	Time to first analgesic requirement (first patient controlled epidural analgesic demand time)	up to 12 hours after cesarean delivery
Secondary	The number of analgesic requirement	The number of patient controlled epidural analgesic requirement per hour	up to 12 hours after cesarean delivery
Secondary	Morphine requirement	Intravenous morphine administration	up to 12 hours after cesarean delivery