Effects of Anesthesia Spinal and Epidural in PregnancyNCT02792933
Air Versus Saline Solution for the Localization of the Epidural Space in Labour Analgesia
A study testing air in epidural space and saline in epidural space in people with Effects of Anesthesia Spinal and Epidural in Pregnancy, run by Instituto de Investigación Hospital Universitario La Paz.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Effects of Anesthesia Spinal and Epidural in Pregnancy
- What is being tested?
- air in epidural space and saline in epidural space
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Infection in the puncture site.
- Refusal of the patient.
- Coagulopathy.
- Severe hypovolaemia.
- Intracranial hypertension.
- Severe aortic or mitral stenosis.
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- 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.
About this study
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
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.
Read the 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.
- Being tested
- air in epidural space, saline in epidural space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
air in epidural spaceProcedure or surgery
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 spaceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: saline in epidural space |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia obtained 30 minutes after the puncture of the epidural block (variation of pain score)
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJul 2009
- Primary completionFeb 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effects of Anesthesia Spinal and Epidural in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792933
- Sponsor's protocol ID
- HULP2914
- Status last verified
- Jun 2016
- First submitted
- 10 May 2016
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 25033878
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02792933
- Acronym / sponsor ID
- HULP2914
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| air in epidural space | Active comparator | Procedure: air in epidural spaceWhen 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. |
| saline in epidural space | Experimental | Procedure: saline in epidural spaceWhen the SLOR technique is used, a continuous pressure will be exerted on the plunger of the Tuohy needle until loss of resistance was felt. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- Infection in the puncture site.
- Refusal of the patient.
- Coagulopathy.
- Severe hypovolaemia.
- Intracranial hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| air in epidural spaceThe 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. | Procedure or surgery | air in epidural space |
| saline in epidural spaceThe 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. | Procedure or surgery | saline in epidural space |
Primary outcome
Analgesia obtained 30 minutes after the puncture of the epidural block (variation of pain score)
Time frame: 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- Background: PubMed 25033878Antibas 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing air in epidural space and saline in epidural space in people with Effects of Anesthesia Spinal and Epidural in Pregnancy, run by Instituto de Investigación Hospital Universitario La Paz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia obtained 30 minutes after the puncture of the epidural block (variation of pain score) (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02792933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.