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

NCT02792933 | Completed DMC

• 1 other identifier: HULP2914
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Effects of Anesthesia Spinal and Epidural in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Analgesia obtained 30 minutes after the puncture of the epidural block (variation of pain score)

  30 min

Study Arms (2)

air in epidural space

ACTIVE COMPARATOR

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.

Procedure: air in epidural space

saline in epidural space

EXPERIMENTAL

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.

Procedure: saline in epidural space

Interventions

air in epidural space PROCEDURE

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 The obturator will be then withdrawn and the low resistance syringe filled with 3-5mL of air will be connected.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.

air in epidural space

saline in epidural space PROCEDURE

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.

saline in epidural space

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Related Publications (1)

• Antibas PL, do Nascimento Junior P, Braz LG, Vitor Pereira Doles J, Modolo 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;2014(7):CD008938. doi: 10.1002/14651858.CD008938.pub2.

  PMID: 25033878 BACKGROUND

MeSH Terms

Interventions

Air; Injections, Epidural; Sodium Chloride

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: June 8, 2016
• Study Start: July 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 15, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share