Air Versus Saline Solution for the Localization of the Epidural Space in Labour Analgesia

Not Applicable

Completed

• Conditions: Effects of Anesthesia Spinal and Epidural in Pregnancy
• Interventions: Procedure: air in epidural space; Procedure: saline in epidural space

• Registration Number: NCT02792933
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief Summary

Epidural space localization using loss of resistance technique with air (ALOR) is controversial in obstetric analgesia due to a minor efficacy and risk of complications, compared with loss of resistance technique with saline (SLOR). This randomized prospective study will compare the efficacy and incidence of most common complications of both techniques in obstetric analgesia.

Detailed Description

A local ethics committee has approved the study. A statistical power calculation was performed and 177 patients per group will be necessary to confirm a 20% difference of efficacy of the block at 30 minutes (α=0,05; β=0,1). Epidural catheter will be inserted and a standardized analgesic protocol will initiate. The efficacy of the block will be assessed after 30 minutes and at delivery. The apparition of adverse effects during puncture and labour will be annotated. The need for repuncture of the block and the repercussion of the technique on the delivery and the fetus will be recorded as well. At 24 hours, investigators will assess the incidence of pain at the site of puncture (PSP) and the level of maternal satisfaction on a 0 to10 numeric scale.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-02
• Study Completion: 2010-06
• Study First Submitted: 2016-05-10
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-08
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
air in epidural space	air in epidural space	When the ALOR epidural localization technique will be used, an intermittent pressure with fast movements will be exerted on the plunger of the syringe while the Tuohy needle will be inserted until loss of resistance was felt.
saline in epidural space	saline in epidural space	When the SLOR technique is used, a continuous pressure will be exerted on the plunger of the Tuohy needle until loss of resistance was felt.

Primary Outcome Measures

Name	Time	Method
Analgesia obtained 30 minutes after the puncture of the epidural block (variation of pain score)	30 min