Different Epidural Initiation Volumes

Inonu University

Status: Completed

Conditions: Pain, Postoperative

Treatments: Drug: 20 mL epidural initiation volume (bupivacaine + fentanyl); Drug: 5 mL epidural initiation volume (bupivacaine + fentanyl); Drug: 10 mL epidural initiation volume (bupivacaine + fentanyl)

Study type: Interventional

Funder types: Other

Identifiers

NCT03156322

Inonu Anesthesia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

81 participants in 3 patient groups

Group 5

Active Comparator group

Description:

5 mL epidural initiation volume (bupivacaine + fentanyl)

Treatment:

Drug: 5 mL epidural initiation volume (bupivacaine + fentanyl)

Group 10

Active Comparator group

Description:

10 mL epidural initiation volume (bupivacaine + fentanyl)

Treatment:

Drug: 10 mL epidural initiation volume (bupivacaine + fentanyl)

Group 20

Active Comparator group

Description:

20 mL epidural initiation volume (bupivacaine + fentanyl)

Treatment:

Drug: 20 mL epidural initiation volume (bupivacaine + fentanyl)