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

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Effects of Anesthesia Spinal and Epidural in Pregnancy

Treatments: Procedure: air in epidural space; Procedure: saline in epidural space

Study type: Interventional

Funder types: Other

Identifiers

NCT02792933

HULP2914

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parturients asking for epidural analgesia during labour .
• Age between 18 and 45 years.
• Spontaneous or induced.
• Cervical dilatation inferior to 6 cm.
• Written informed consent.

Exclusion criteria

• Infection in the puncture site.
• Refusal of the patient.
• Coagulopathy.
• Severe hypovolaemia.
• Intracranial hypertension.
• Severe aortic or mitral stenosis.
• Systemic infection.
• Non collaborating patient.
• Incapacity of communicating or lack of comprehension of the study by the parturient
• Prior neurological symptoms or demyelinising lesions.
• Valvular stenosis.
• Severe spinal deviation.
• Patient previously operated of spinal surgery in the site of puncture.

Trial design

400 participants in 2 patient groups

air in epidural space

Active Comparator group

Description:

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.

Treatment:

Procedure: air in epidural space

saline in epidural space

Experimental group

Description:

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.

Treatment:

Procedure: saline in epidural space