Obstetric PainPhase 3NCT05196256
Study Comparing Dural Puncture Epidural With Epidural and Combined Spinal Epidural Anesthesia for Obstetric Analgesia.
A Phase 3 study testing Dural puncture, Combined spinal epidural analgesia and Epidural analgesia in people with Obstetric Pain and Analgesia, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
This will be a prospective, randomized, double blind, controlled clinical trial. Epidural analgesia (EP) is currently the method of choice to ensure the comfort of the parturient during childbirth. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Pain, Analgesia
- What is being tested?
- Dural puncture, Combined spinal epidural analgesia and Epidural analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jun 2022to 30 Jul 2023
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women at term (37-42 weeks of amenorrhea)
- American Society of Anesthesiologists (ASA) class 1 or 2
- no language barrier, i.e; speaking French, Dutch or English or accompanied by a reliable translator
- single pregnancy
- Parity 1 , 2 or 3
- cephalic fetal presentation
- active labor with cervical dilatation less than 5 cm
Who cannot join
- Contraindications to neuraxial anesthesia
- major pathologies of pregnancy (preeclampsia)
- decompensated gestational diabetes
- diabetes type 1 or 2
- known serious fetal pathology
- maternal previous diseases increasing the risk of caesarean section (caesarean section, uterine malformation, scarred uterus, surgery of the uterine cervix)
- fourth or more deliveries
- extreme pre-pregnancy BMI (< 18 or > 40)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Controlled, Pilot Study Comparing Three Different Anesthesic Techniques for Pregnant Women in Labour: Dural Puncture Epidural, Epidural and Combined Spinal Epidural. Evaluation of the Pain Control and the Hypotension Incidence All Along the Labour and Delivery
This will be a prospective, randomized, double blind, controlled clinical trial.
Epidural analgesia (EP) is currently the method of choice to ensure the comfort of the parturient during childbirth. Technical and pharmacological advances in recent years have made it possible to provide patients with high quality analgesia with individualized control, associated with extremely limited motor block. However, sometimes this technique fails due to a prolonged delay in action, or insufficient sensory block.
Read more
An alternative technique has become popular in recent years, the combined peri-spinal anesthesia also called sequential (CSE). It combines the administration of low doses of local anesthetics and/or intrathecal opiates before the placement of the catheter in the epidural space and the use of the catheter as in a classical technique. This technique would allow a more rapid onset of analgesia, a more complete relief of the patient, and a lower degree of failure. However, it could be accompanied by a greater risk of maternal hemodynamic instability, fetal bradycardia, and a longer expulsion period. In addition, the effectiveness of the catheter injection can only be assessed when the effects of the spinal injected drugs have worn off.
In order to limit these undesirable effects, it has been proposed to perform a dural puncture as performed in the sequential technique but without intrathecal drug injection (DPE). In this way, a "tunnel" is created, allowing the diffusion of drugs from the epidural space to the subarachnoid space. Thus, the initiation of anesthesia would be faster with a lower risk of lateralization compared to the standard epidural, also allowing a decrease in the consumption of local anesthetics and without the undesirable effects of the sequential. Although this technique recently introduced in obstetrical analgesia appears promising, very few studies to date have evaluated its effectiveness and safety.
The hypothesis of the study is that the Epidural with Dural puncture (DPE) provides a higher quality of analgesia than standard epidural while having fewer adverse effects than combined epidural, in particular a lower incidence of maternal hypotension.
The primary objectives are:
- testing the quality of analgesia with DPE compared to PE and CSE. This will be assessed by determining the area under the curve of Visual Analog Scale (VAS) measurements observed from the beginning of obstetric analgesia and throughout the delivery.
- testing the rate of maternal hypotension with DPE compared with PE and CSE, with hypotension defined as a decrease in systolic blood pressure (SBP) greater than 15% from the SBP measured at the time of the parturient arrival in the labor room, a SBP < 90 mmHg, or any decrease in pressure associated with disabling symptomatology (dizziness, yawning, nausea).
For this purpose, the investigators will randomize a total of 90 patients, 30 in each of the groups. The patients will receive one of the three techniques, all of them will benefit from the administration of epidural analgesia with low concentration local anesthetics and opioids on a Intermittent bolus modus (PIB). Patients assigned to the combined spinal epidural modus will receive a injection of a small quantity of local anesthetics and opioids (Levobupivacaine 2.5mg and Sufentanyl 2.5 mcg) in the intrathecal space. A non-blinded anesthesiologists will perform the anesthetics technique and leave the room immediately; a blinded anesthesiologists will do the data collection and act according to protocol if the patient in case of pain non controllable by the patient controlled anesthesia, in case of hypotension or any other possible complications.
Data collection will take place before starting the locoregional anesthesia technique, at the moment when the anesthetists non blinded leaves the room, 10 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours after the start of the analgesia and at the moment of the expulsion of the baby.
Patients and care providers will be blinded to which technic is being given. Data will be statistically analyzed using area under the curve and two-dimension variance analysis.
- Conditions
- Obstetric Pain, Analgesia
- Being tested
- Dural puncture, Combined spinal epidural analgesia, Epidural analgesia, Sufentanyl/Levobupivacaine
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural punctureProcedure or surgery
Dural puncture with a 25 Gauge needle without injection of local anesthetics into the dural space
Combined spinal epidural analgesiaProcedure or surgery
Standard epidural preceded by a dural puncture with a 25G sequential needle and intrathecal injection of 2.5 ug of Sufentanil and 2.5 mg of normobaric Levobupivacaine
Epidural analgesiaProcedure or surgery
Epidural analgesia
Sufentanyl/LevobupivacaineDrug
Epidural analgesia
| Study group | Role | What they receive |
|---|---|---|
| Dural Puncture Epidural group (DPE) | Experimental | Dural puncture with a 25 Gauge needle, then placement of the epidural catheter (Tuohy 18 Gauge). The medication consists of Levobupivacaine 0.0625% and Sufentanyl 0.25 mcg/mL, both administered epidurally with a programmed intermittent bolus mode (PIB) and patient controlled epidural analgesia (PCEA). An initial fractionated bolus of 20 mL will be administered epidurally, then automatic intermittent bolus of 10 mL will be administered, the first one after 30 min and then every 40min. PCEA pump will allow 10 mL every 20 min, all along the dilatation and expulsion period. Receives: Procedure: Dural puncture; Drug: Sufentanyl/Levobupivacaine |
| Epidural group (EP) | Active comparator | Placement of an epidural catheter through a 18 Gauge Tuohy needle. The medication consists of Levobupivacaine 0.0625% and Sufentanyl 0.25 mcg/mL, both administered epidurally with a programmed intermittent boluses mode (PIB) and patient controlled epidural analgesia (PCEA); An initial fraction bolus of 20ml will be administered epidurally, then automatic intermittent bolus of 10 mL will be administered, the first one after 30 min and then every 40 min. PCEA pump will allow 10 mL every 20 min, all along the dilatation and expulsion period. Receives: Procedure: Epidural analgesia; Drug: Sufentanyl/Levobupivacaine |
| Combined Spinal-Epidural group (CSE) | Active comparator | Spinal injection through a 25 Gauge needle of Levobupivacaine 2.5mg and Sufentanyl 2.5 mcg in a total volume of 2 mL, placing an epidural catheter through a Tuohy 18 Gauge needle. The epidural medication consists of Levobupivacaine 0.0625% and Sufentanyl 0.25 mcg/mL. The epidural medication is administered on a programmed intermittent bolus mode (PIB) and patient controlled epidural analgesia (PCEA). An initial fractioned bolus of 20 mL will be administered epidurally 30 min after the intrathecal injection, then automatic intermittent bolus of 10 mL will be administered, the first one after 30 min and then every 40 min. PCEA pump will allow 10 mL every 20min, all along the dilatation and expulsion period. Receives: Procedure: Combined spinal epidural analgesia; Drug: Sufentanyl/Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of the pain visual analog scale (VAS)
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Measured: 10 minutes after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Measured: 15 minutes after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Measured: 30 minutes after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Measured: 1 hour after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Measured: 2 hours after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Measured: 3 hours after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Measured: 4 hours after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Measured: 6 hours after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Measured: From the start of the anesthesia technique until delivery of the baby (max up to 24 hours)
Incidence of maternal hypotension
To test whether DPE is accompanied by a lower incidence of maternal hypotension than CSE. For the purposes of this study, hypotension is defined as a decrease of more than 15% in systolic blood pressure (SBP) from the first pressure taken when the patient was admitted to the labor room, SBP < 90 mm Hg, or any decrease in SBP accompanied by symptomatology (malaise, nausea) requiring rescue treatment. Incidence will be measured as percentage of patients presenting a hypotension according to this definition.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start30 Jun 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Obstetric PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis SCHMARTZ, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196256
- Sponsor's protocol ID
- CHUB-MAT-DPE
- Status last verified
- Feb 2022
- First submitted
- 30 Dec 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sodha S, Reeve A, Fernando R. Central neuraxial analgesia for labor: an update of the literature. Pain Manag. 2017 Sep;7(5):419-426. doi: 10.2217/pmt-2017-0010. Epub 2017 Sep 22.
PubMed 28936908Sng BL, Kwok SC, Sia AT. Modern neuraxial labour analgesia. Curr Opin Anaesthesiol. 2015 Jun;28(3):285-9. doi: 10.1097/ACO.0000000000000183.
PubMed 25827278George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.
PubMed 23223119Pan PH, Bogard TD, Owen MD. Incidence and characteristics of failures in obstetric neuraxial analgesia and anesthesia: a retrospective analysis of 19,259 deliveries. Int J Obstet Anesth. 2004 Oct;13(4):227-33. doi: 10.1016/j.ijoa.2004.04.008.
PubMed 15477051Bucstain C, Garmi G, Zafran N, Zuarez-Easton S, Carmeli J, Salim R. Risk factors and peripartum outcomes of failed epidural: a prospective cohort study. Arch Gynecol Obstet. 2017 May;295(5):1119-1125. doi: 10.1007/s00404-017-4337-5. Epub 2017 Mar 10.
PubMed 28283828Gambling D, Berkowitz J, Farrell TR, Pue A, Shay D. A randomized controlled comparison of epidural analgesia and combined spinal-epidural analgesia in a private practice setting: pain scores during first and second stages of labor and at delivery. Anesth Analg. 2013 Mar;116(3):636-43. doi: 10.1213/ANE.0b013e31827e4e29. Epub 2013 Feb 11.
PubMed 23400985Goodman SR, Smiley RM, Negron MA, Freedman PA, Landau R. A randomized trial of breakthrough pain during combined spinal-epidural versus epidural labor analgesia in parous women. Anesth Analg. 2009 Jan;108(1):246-51. doi: 10.1213/ane.0b013e31818f896f.
PubMed 19095858Booth JM, Pan JC, Ross VH, Russell GB, Harris LC, Pan PH. Combined Spinal Epidural Technique for Labor Analgesia Does Not Delay Recognition of Epidural Catheter Failures: A Single-center Retrospective Cohort Survival Analysis. Anesthesiology. 2016 Sep;125(3):516-24. doi: 10.1097/ALN.0000000000001222.
PubMed 27380107Heesen M, Van de Velde M, Klohr S, Lehberger J, Rossaint R, Straube S. Meta-analysis of the success of block following combined spinal-epidural vs epidural analgesia during labour. Anaesthesia. 2014 Jan;69(1):64-71. doi: 10.1111/anae.12456. Epub 2013 Oct 28.
PubMed 24164577Hattler J, Klimek M, Rossaint R, Heesen M. The Effect of Combined Spinal-Epidural Versus Epidural Analgesia in Laboring Women on Nonreassuring Fetal Heart Rate Tracings: Systematic Review and Meta-analysis. Anesth Analg. 2016 Oct;123(4):955-64. doi: 10.1213/ANE.0000000000001412.
PubMed 27509225Simmons SW, Taghizadeh N, Dennis AT, Hughes D, Cyna AM. Combined spinal-epidural versus epidural analgesia in labour. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD003401. doi: 10.1002/14651858.CD003401.pub3.
PubMed 23076897Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.
PubMed 28067707Poma S, Scudeller L, Verga C, Mirabile G, Gardella B, Broglia F, Ciceri M, Fuardo M, Pellicori S, Gerletti M, Zizzi S, Masserini E, Delmonte MP, Iotti GA. Effects of combined spinal-epidural analgesia on first stage of labor: a cohort study. J Matern Fetal Neonatal Med. 2019 Nov;32(21):3559-3565. doi: 10.1080/14767058.2018.1467892. Epub 2018 May 17.
PubMed 29768964Van de Velde M, Teunkens A, Hanssens M, Vandermeersch E, Verhaeghe J. Intrathecal sufentanil and fetal heart rate abnormalities: a double-blind, double placebo-controlled trial comparing two forms of combined spinal epidural analgesia with epidural analgesia in labor. Anesth Analg. 2004 Apr;98(4):1153-1159. doi: 10.1213/01.ANE.0000101980.34587.66.
PubMed 15041616Cappiello E, O'Rourke N, Segal S, Tsen LC. A randomized trial of dural puncture epidural technique compared with the standard epidural technique for labor analgesia. Anesth Analg. 2008 Nov;107(5):1646-51. doi: 10.1213/ane.0b013e318184ec14.
PubMed 18931227
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Controlled, Pilot Study Comparing Three Different Anesthesic Techniques for Pregnant Women in Labour: Dural Puncture Epidural, Epidural and Combined Spinal Epidural. Evaluation of the Pain Control and the Hypotension Incidence All Along the Labour and Delivery
- ClinicalTrials.gov ID
- NCT05196256
- Acronym / sponsor ID
- CHUB-MAT-DPE
- Conditions
- Obstetric Pain, Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 19 Jan 2022 (actual)
- 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.
This will be a prospective, randomized, double blind, controlled clinical trial.
Epidural analgesia (EP) is currently the method of choice to ensure the comfort of the parturient during childbirth. Technical and pharmacological advances in recent years have made it possible to provide patients with high quality analgesia with individualized control, associated with extremely limited motor block. However, sometimes this technique fails due to a prolonged delay in action, or insufficient sensory block.
An alternative technique has become popular in recent years, the combined peri-spinal anesthesia also called sequential (CSE). It combines the administration of low doses of local anesthetics and/or intrathecal opiates before the placement of the catheter in the epidural space and the use of the catheter as in a classical technique. This technique would allow a more rapid onset of analgesia, a more complete relief of the patient, and a lower degree of failure. However, it could be accompanied by a greater risk of maternal hemodynamic instability, fetal bradycardia, and a longer expulsion period. In addition, the effectiveness of the catheter injection can only be assessed when the effects of the spinal injected drugs have worn off.
In order to limit these undesirable effects, it has been proposed to perform a dural puncture as performed in the sequential technique but without intrathecal drug injection (DPE). In this way, a "tunnel" is created, allowing the diffusion of drugs from the epidural space to the subarachnoid space. Thus, the initiation of anesthesia would be faster with a lower risk of lateralization compared to the standard epidural, also allowing a decrease in the consumption of local anesthetics and without the undesirable effects of the sequential. Although this technique recently introduced in obstetrical analgesia appears promising, very few studies to date have evaluated its effectiveness and safety.
The hypothesis of the study is that the Epidural with Dural puncture (DPE) provides a higher quality of analgesia than standard epidural while having fewer adverse effects than combined epidural, in particular a lower incidence of maternal hypotension.
The primary objectives are:
- testing the quality of analgesia with DPE compared to PE and CSE. This will be assessed by determining the area under the curve of Visual Analog Scale (VAS) measurements observed from the beginning of obstetric analgesia and throughout the delivery.
- testing the rate of maternal hypotension with DPE compared with PE and CSE, with hypotension defined as a decrease in systolic blood pressure (SBP) greater than 15% from the SBP measured at the time of the parturient arrival in the labor room, a SBP < 90 mmHg, or any decrease in pressure associated with disabling symptomatology (dizziness, yawning, nausea).
For this purpose, the investigators will randomize a total of 90 patients, 30 in each of the groups. The patients will receive one of the three techniques, all of them will benefit from the administration of epidural analgesia with low concentration local anesthetics and opioids on a Intermittent bolus modus (PIB). Patients assigned to the combined spinal epidural modus will receive a injection of a small quantity of local anesthetics and opioids (Levobupivacaine 2.5mg and Sufentanyl 2.5 mcg) in the intrathecal space. A non-blinded anesthesiologists will perform the anesthetics technique and leave the room immediately; a blinded anesthesiologists will do the data collection and act according to protocol if the patient in case of pain non controllable by the patient controlled anesthesia, in case of hypotension or any other possible complications.
Data collection will take place before starting the locoregional anesthesia technique, at the moment when the anesthetists non blinded leaves the room, 10 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours after the start of the analgesia and at the moment of the expulsion of the baby.
Patients and care providers will be blinded to which technic is being given. Data will be statistically analyzed using area under the curve and two-dimension variance analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dural Puncture Epidural group (DPE) | Experimental | Procedure: Dural puncture, Drug: Sufentanyl/LevobupivacaineDural puncture with a 25 Gauge needle, then placement of the epidural catheter (Tuohy 18 Gauge). The medication consists of Levobupivacaine 0.0625% and Sufentanyl 0.25 mcg/mL, both administered epidurally with a programmed intermittent bolus mode (PIB) and patient controlled epidural analgesia (PCEA). An initial fractionated bolus of 20 mL will be administered epidurally, then automatic intermittent bolus of 10 mL will be administered, the first one after 30 min and then every 40min. PCEA pump will allow 10 mL every 20 min, all along the dilatation and expulsion period. |
| Epidural group (EP) | Active comparator | Procedure: Epidural analgesia, Drug: Sufentanyl/LevobupivacainePlacement of an epidural catheter through a 18 Gauge Tuohy needle. The medication consists of Levobupivacaine 0.0625% and Sufentanyl 0.25 mcg/mL, both administered epidurally with a programmed intermittent boluses mode (PIB) and patient controlled epidural analgesia (PCEA); An initial fraction bolus of 20ml will be administered epidurally, then automatic intermittent bolus of 10 mL will be administered, the first one after 30 min and then every 40 min. PCEA pump will allow 10 mL every 20 min, all along the dilatation and expulsion period. |
| Combined Spinal-Epidural group (CSE) | Active comparator | Procedure: Combined spinal epidural analgesia, Drug: Sufentanyl/LevobupivacaineSpinal injection through a 25 Gauge needle of Levobupivacaine 2.5mg and Sufentanyl 2.5 mcg in a total volume of 2 mL, placing an epidural catheter through a Tuohy 18 Gauge needle. The epidural medication consists of Levobupivacaine 0.0625% and Sufentanyl 0.25 mcg/mL. The epidural medication is administered on a programmed intermittent bolus mode (PIB) and patient controlled epidural analgesia (PCEA). An initial fractioned bolus of 20 mL will be administered epidurally 30 min after the intrathecal injection, then automatic intermittent bolus of 10 mL will be administered, the first one after 30 min and then every 40 min. PCEA pump will allow 10 mL every 20min, all along the dilatation and expulsion period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant women at term (37-42 weeks of amenorrhea)
- American Society of Anesthesiologists (ASA) class 1 or 2
- no language barrier, i.e; speaking French, Dutch or English or accompanied by a reliable translator
- single pregnancy
- Parity 1 , 2 or 3
Key exclusion criteria (8 listed)
- Contraindications to neuraxial anesthesia
- major pathologies of pregnancy (preeclampsia)
- decompensated gestational diabetes
- diabetes type 1 or 2
- known serious fetal pathology
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 |
|---|---|---|
| Dural punctureDural puncture with a 25 Gauge needle without injection of local anesthetics into the dural space | Procedure or surgery | Dural Puncture Epidural group (DPE) |
| Combined spinal epidural analgesiaStandard epidural preceded by a dural puncture with a 25G sequential needle and intrathecal injection of 2.5 ug of Sufentanil and 2.5 mg of normobaric Levobupivacaine | Procedure or surgery | Combined Spinal-Epidural group (CSE) |
| Epidural analgesiaEpidural analgesia | Procedure or surgery | Epidural group (EP) |
| Sufentanyl/LevobupivacaineEpidural analgesia | Drug | Combined Spinal-Epidural group (CSE), Dural Puncture Epidural group (DPE), Epidural group (EP) |
Primary outcome
Area under the curve of the pain visual analog scale (VAS)
Time frame: 10 minutes after the start of the anesthesia technique
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Area under the curve of the pain visual analog scale (VAS)
Time frame: 15 minutes after the start of the anesthesia technique
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Area under the curve of the pain visual analog scale (VAS)
Time frame: 30 minutes after the start of the anesthesia technique
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Area under the curve of the pain visual analog scale (VAS)
Time frame: 1 hour after the start of the anesthesia technique
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Area under the curve of the pain visual analog scale (VAS)
Time frame: 2 hours after the start of the anesthesia technique
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Area under the curve of the pain visual analog scale (VAS)
Time frame: 3 hours after the start of the anesthesia technique
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Area under the curve of the pain visual analog scale (VAS)
Time frame: 4 hours after the start of the anesthesia technique
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Area under the curve of the pain visual analog scale (VAS)
Time frame: 6 hours after the start of the anesthesia technique
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Area under the curve of the pain visual analog scale (VAS)
Time frame: From the start of the anesthesia technique until delivery of the baby (max up to 24 hours)
Evaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a "blind" team member.
Incidence of maternal hypotension
Time frame: 24 hours
To test whether DPE is accompanied by a lower incidence of maternal hypotension than CSE. For the purposes of this study, hypotension is defined as a decrease of more than 15% in systolic blood pressure (SBP) from the first pressure taken when the patient was admitted to the labor room, SBP < 90 mm Hg, or any decrease in SBP accompanied by symptomatology (malaise, nausea) requiring rescue treatment. Incidence will be measured as percentage of patients presenting a hypotension according to this definition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Background: PubMed 28936908Sodha S, Reeve A, Fernando R. Central neuraxial analgesia for labor: an update of the literature. Pain Manag. 2017 Sep;7(5):419-426. doi: 10.2217/pmt-2017-0010. Epub 2017 Sep 22.
- Background: PubMed 25827278Sng BL, Kwok SC, Sia AT. Modern neuraxial labour analgesia. Curr Opin Anaesthesiol. 2015 Jun;28(3):285-9. doi: 10.1097/ACO.0000000000000183.
- Background: PubMed 23223119George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.
- Background: PubMed 15477051Pan PH, Bogard TD, Owen MD. Incidence and characteristics of failures in obstetric neuraxial analgesia and anesthesia: a retrospective analysis of 19,259 deliveries. Int J Obstet Anesth. 2004 Oct;13(4):227-33. doi: 10.1016/j.ijoa.2004.04.008.
- Background: PubMed 28283828Bucstain C, Garmi G, Zafran N, Zuarez-Easton S, Carmeli J, Salim R. Risk factors and peripartum outcomes of failed epidural: a prospective cohort study. Arch Gynecol Obstet. 2017 May;295(5):1119-1125. doi: 10.1007/s00404-017-4337-5. Epub 2017 Mar 10.
- Background: PubMed 23400985Gambling D, Berkowitz J, Farrell TR, Pue A, Shay D. A randomized controlled comparison of epidural analgesia and combined spinal-epidural analgesia in a private practice setting: pain scores during first and second stages of labor and at delivery. Anesth Analg. 2013 Mar;116(3):636-43. doi: 10.1213/ANE.0b013e31827e4e29. Epub 2013 Feb 11.
- Background: PubMed 19095858Goodman SR, Smiley RM, Negron MA, Freedman PA, Landau R. A randomized trial of breakthrough pain during combined spinal-epidural versus epidural labor analgesia in parous women. Anesth Analg. 2009 Jan;108(1):246-51. doi: 10.1213/ane.0b013e31818f896f.
- Background: PubMed 27380107Booth JM, Pan JC, Ross VH, Russell GB, Harris LC, Pan PH. Combined Spinal Epidural Technique for Labor Analgesia Does Not Delay Recognition of Epidural Catheter Failures: A Single-center Retrospective Cohort Survival Analysis. Anesthesiology. 2016 Sep;125(3):516-24. doi: 10.1097/ALN.0000000000001222.
- Background: PubMed 24164577Heesen M, Van de Velde M, Klohr S, Lehberger J, Rossaint R, Straube S. Meta-analysis of the success of block following combined spinal-epidural vs epidural analgesia during labour. Anaesthesia. 2014 Jan;69(1):64-71. doi: 10.1111/anae.12456. Epub 2013 Oct 28.
- Background: PubMed 27509225Hattler J, Klimek M, Rossaint R, Heesen M. The Effect of Combined Spinal-Epidural Versus Epidural Analgesia in Laboring Women on Nonreassuring Fetal Heart Rate Tracings: Systematic Review and Meta-analysis. Anesth Analg. 2016 Oct;123(4):955-64. doi: 10.1213/ANE.0000000000001412.
- Background: PubMed 23076897Simmons SW, Taghizadeh N, Dennis AT, Hughes D, Cyna AM. Combined spinal-epidural versus epidural analgesia in labour. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD003401. doi: 10.1002/14651858.CD003401.pub3.
- Background: PubMed 28067707Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.
- Individual participant dataSharing planned: No
Related trials for Obstetric Pain
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
RecruitingPhase 4
COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
Complex Obstetric Surgery, Perioperative Pain Management
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dural puncture, Combined spinal epidural analgesia and Epidural analgesia in people with Obstetric Pain and Analgesia, run by Brugmann University Hospital at 1 site in Belgium.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis Schmartz, MD (+3224773996, denis.schmartz@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of the pain visual analog scale (VAS) (time frame: 10 minutes after the start of the anesthesia technique). The study lists 10 primary outcomes in all. 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 NCT05196256, which also lists 23 linked publications.
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 24 Feb 2022.