Effects of Anesthesia Spinal and Epidural in Pregnancy
Conditions
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.
Interventions
PROCEDUREair 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 The obturator will be then withdrawn and the low resistance syringe filled with 3-5mL of air will be connected.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.
PROCEDUREsaline 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 The obturator will be withdrawn and the low resistance syringe filled with 3-5mL of saline solution will be connected.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.
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analgesia obtained 30 minutes after the puncture of the epidural block (variation of pain score) | 30 min |
Outcome results
None listed