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

Effects of Anesthesia Spinal and Epidural in Pregnancy Clinical Trial

Official title:

Localization of the Epidural Space Using the Loss of Resistance Technique for Labour Analgesia: A Randomized Controlled Trial Comparing Air Versus Saline Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792933
• Other study ID #: HULP2914
• Status: Completed
• Phase: N/A
• First received: May 10, 2016
• Last updated: June 14, 2016
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2016
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Effects of Anesthesia Spinal and Epidural in Pregnancy

Intervention

Procedure:
• air in epidural space
The epidural puncture will be performed in the L3-L4 or L4-L5 interspinous space in a seated position. A local anaesthesia with 2-5 mL of 2% lidocaine will be applied subcutaneously using a 25Gm 25mm needle. The epidural space will be localized using a Perifix® set by inserting the Tuohy needle in the ligamentum flavum or the interspinous space. The obturator will be then withdrawn and the low resistance syringe filled with 3-5mL of air will be connected. After localizing the epidural space, the catheter will be inserted 3-5 cm. An aspiration test will be performed through the catheter in a decline position with a 2 mL syringe, and a 3mL test dose with bupivacaine 0,25% plus epinephrine 1/200.000 will be administered to exclude an intradural or an intravascular position of the catheter.
• saline in epidural space
The epidural puncture will be performed in the L3-L4 or L4-L5 interspinous space in a seated position. A local anaesthesia with 2-5 mL of 2% lidocaine will be applied subcutaneously using a 25Gm 25mm needle. The epidural space will be localized using a Perifix® set by inserting the Tuohy needle in the ligamentum flavum or the interspinous space. The obturator will be withdrawn and the low resistance syringe filled with 3-5mL of saline solution will be connected. After localizing the epidural space, the catheter will be inserted 3-5 cm. An aspiration test will be performed through the catheter in a decline position with a 2 mL syringe, and a 3mL test dose with bupivacaine 0,25% plus epinephrine 1/200.000 will be administered to exclude an intradural or an intravascular position of the catheter.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

References & Publications (1)

Antibas PL, do Nascimento Junior P, Braz LG, Vitor Pereira Doles J, Módolo NS, El Dib R. Air versus saline in the loss of resistance technique for identification of the epidural space. Cochrane Database Syst Rev. 2014 Jul 18;(7):CD008938. doi: 10.1002/14651858.CD008938.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesia obtained 30 minutes after the puncture of the epidural block (variation of pain score)		30 min	No