Different Epidural Initiation Volumes

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03156322

Enrollment

Registered

2017-05-17

Start date

2016-01-01

Completion date

2017-01-01

Last updated

2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

cesarean section, combined spinal epidural anesthesia, patient controlled epidural analgesia, postoperative pain

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.

Interventions

DRUG5 mL epidural initiation volume (bupivacaine + fentanyl)

5 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter

DRUG10 mL epidural initiation volume (bupivacaine + fentanyl)

10 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter

DRUG20 mL epidural initiation volume (bupivacaine + fentanyl)

20 mL 0.625% bupivacaine + + 2 μg/mL fentanyl solution is administered from epidural catheter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Other

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026