Combined Spinal/Epidural (CSE) Saline Duration/Spread

Wake Forest University (WFU)

Status and phase: Terminated; Phase 2

Conditions: Labor Pain

Treatments: Other: 15 mls sterile normal saline; Other: Sterile normal saline 0 mls

Study type: Interventional

Funder types: Other

Identifiers

NCT01062893

IRB00009631

Details and patient eligibility

About

An attempt is being made to see if by injecting a set volume of sterile saline into the epidural space during the treatment of labor pain with a combined spinal/epidural (CSE) increases the amount of pain relief obtained and makes the labor analgesia lasts longer. Subjects are in the study from the time their CSE is placed until they request additional pain medication from the spinal dose of numbing medicine wearing off.

Enrollment: 82 patients

Sex: Female

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age greater than 12 years of age
• ASA status 1 or 2
• cervical dilation < 6cm

Exclusion criteria

• ASA assigned 3 or 4
• advanced labor (> 6cm cervical dilated)
• distorted epidural anatomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

82 participants in 2 patient groups, including a placebo group

0 mls saline injected

Placebo Comparator group

Description:

NO SALINE INJECTED

Treatment:

Other: Sterile normal saline 0 mls

15 mls saline

Active Comparator group

Description:

15ML SALINE ADMINISTERED EPIDURALLY

Treatment:

Other: 15 mls sterile normal saline