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NCT Number: NCT02792933

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

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.

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Key information

Conditions

Effects of Anesthesia Spinal and Epidural in Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 30 min

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 8, 2016
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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