Labor Epidural AnalgesiaPhase 4PIEB-CTNCT02768272
PIEB vs PCEA With Epidural or CSE Technique. A Randomized Double Blind Clinical Trial
A Phase 4 study testing PCEA vs PIEB and Epidural vs CSE in people with Labor Epidural Analgesia, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The investigators have design a randomized double blind clinical trial to know the incidence of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early cervical dilation) comparing two epidural analgesic regimes: programed intermittent epidural boluses versus patient controlled epidural analgesia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Epidural Analgesia
- What is being tested?
- PCEA vs PIEB and Epidural vs CSE
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2016to Aug 2017
- Phase
- Phase 4
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 40 years
- Gestational age between 37 and 41 weeks
- Singleton pregnancies
- Nulliparity
- Spontaneous or induced labor
- Cervical dilation less than four centimeters
Who cannot join
- Do not meet all the inclusion criteria
- Do not consent to the study
- Systemic medical pathologies as pre-eclampsia, insulin-treated gestational diabetes or multiple sclerosis that could influence medical decision during labour and/or make randomization unfeasible
- Contraindication for neuraxial analgesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double Blind Clinical Trial Comparing Programed Intermittent Epidural Boluses (PIEB) Versus Patient Controlled Epidural Analgesia (PCEA) With Epidural or Combined Spinal-epidural (CSE) Technique
The investigators have design a randomized double blind clinical trial to know the incidence of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early cervical dilation) comparing two epidural analgesic regimes: programed intermittent epidural boluses versus patient controlled epidural analgesia. The role of the epidural technique (epidural versus combined spinal-epidural) in the incidence of BP will be also evaluated.
Read the detailed description
Women in labor receiving epidural analgesia may experience breakthrough pain (BP) that requires the use of additional medication and that is a source of dissatisfaction with the analgesic treatment for labor.
The investigators can define two types of BP: 'primary breakthrough pain' is the first moment when the patient requests analgesia during labor. 'Secondary breakthrough pain' can be defined as the time a previously effective epidural analgesia turns ineffective.
The BP may have multiple causes, such as delivery progression and catheter misplacement. There is no single pattern to provide adequate neuraxial analgesia for labor, but for certain patients and specific clinical situations some methods provide advantages over others.
The choice of a suitable system of epidural drug delivery has an important role in getting proper analgesia and a low incidence of breakthrough pain during labor. In order to develop preventive strategies for BP, some clinical scales to estimate its incidence rate have been described. Among risk factors for BP the investigators can include: Nulliparity, epidural catheter placement at an earlier cervical dilation, neonatal weight and technique performed (epidural versus combined spinal-epidural - CSE).
In addition, technological development has offered us new treatment modalities of pain management during childbirth have evolved recently to improve maternal satisfaction, as well as to treat and prevent BP: Patient Controlled Epidural Analgesia (PCEA) added or not to a continuous epidural infusion (CEI), computer integrated PCEA (CI-PCEA) and automatic or programed intermittent epidural boluses (PIEB).
Nowadays, there is no evidence about the best epidural analgesic treatment or the optimum epidural punction in order to reduce BP episodes and, hence, increase maternal satisfaction.
Therefore, the investigators have design a randomized double blind clinical trial to know the incidence of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early cervical dilation) comparing two epidural analgesic regimes added to a contiuous infusion of L-bupivacaine plus fentanyl: programed intermittent epidural boluses versus patient controlled epidural analgesia. The role of the epidural technique (epidural versus combined spinal-epidural) in the incidence of BP will be also evaluated.
- Conditions
- Labor Epidural Analgesia
- Being tested
- PCEA vs PIEB, Epidural vs CSE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCEA vs PIEBDevice
We evaluate the relation between the distribution of L-bupivacaine plus fentanyl in the epidural space and the incedence of breaktrough pain during labor
Epidural vs CSEProcedure or surgery
We evaluate the relation between the type of epidural technique and the incedence of breaktrough pain during labor
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia | Experimental | Randomized allocation to receive patient controlled epidural analgesia or programed intermittent epidural boluses Receives: Device: PCEA vs PIEB |
| Epidural technique | Experimental | Randomized allocation to be punctioned a conventional epidural or a combined spinal-epidural technique Receives: Procedure: Epidural vs CSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of breakthrough pain
Evaluation of breakthough pain episodes since epidural punction to delivery
Measured: Labor
Secondary outcomes (3)
Total epidural infusion volume
Measurement of the total epidural infusion volume administered to the patient
Measured: Labor
Incidence of epidural failure
Assesment the incidence of failed epdirual technique
Measured: Labor
Mode of delivery (spontaneous, intrumental and cesarean section)
Analysis of the potential relation of the interventions with the type of delivery
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start1 Mar 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Labor Epidural AnalgesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilia Guasch, Hospital Universitario La Paz
- Investigators
- Emilia Guasch, MD, PhD, Principal investigator, Anesthesia and Intensive Care Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768272
- Sponsor's protocol ID
- 2014-004696-24
- Other IDs
- 2014
- Acronym
- PIEB-CT
- Status last verified
- Aug 2017
- First submitted
- 9 May 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Hess PE, Pratt SD, Lucas TP, Miller CG, Corbett T, Oriol N, Sarna MC. Predictors of breakthrough pain during labor epidural analgesia. Anesth Analg. 2001 Aug;93(2):414-8, 4th contents page. doi: 10.1097/00000539-200108000-00036.
PubMed 11473872Loubert C, Hinova A, Fernando R. Update on modern neuraxial analgesia in labour: a review of the literature of the last 5 years. Anaesthesia. 2011 Mar;66(3):191-212. doi: 10.1111/j.1365-2044.2010.06616.x.
PubMed 21320088van der Vyver M, Halpern S, Joseph G. Patient-controlled epidural analgesia versus continuous infusion for labour analgesia: a meta-analysis. Br J Anaesth. 2002 Sep;89(3):459-65. doi: 10.1093/bja/aef217.
PubMed 12402726American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Practice guidelines for obstetric anesthesia: an updated report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Anesthesiology. 2007 Apr;106(4):843-63. doi: 10.1097/01.anes.0000264744.63275.10. No abstract available.
PubMed 17413923Hogan Q. Distribution of solution in the epidural space: examination by cryomicrotome section. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):150-6. doi: 10.1053/rapm.2002.29748.
PubMed 11915061Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. doi: 10.1213/01.ane.0000197778.57615.1a.
PubMed 16492849Halpern SH, Carvalho B. Patient-controlled epidural analgesia for labor. Anesth Analg. 2009 Mar;108(3):921-8. doi: 10.1213/ane.0b013e3181951a7f.
PubMed 19224805Stratmann G, Gambling DR, Moeller-Bertram T, Stackpole J, Pue AF, Berkowitz J. A randomized comparison of a five-minute versus fifteen-minute lockout interval for PCEA during labor. Int J Obstet Anesth. 2005 Jul;14(3):200-7. doi: 10.1016/j.ijoa.2004.12.008.
PubMed 15936187Sia AT, Lim Y, Ocampo CE. Computer-integrated patient-controlled epidural analgesia: a preliminary study on a novel approach of providing pain relief in labour. Singapore Med J. 2006 Nov;47(11):951-6.
PubMed 17075662Sng BL, Sia AT, Lim Y, Woo D, Ocampo C. Comparison of computer-integrated patient-controlled epidural analgesia and patient-controlled epidural analgesia with a basal infusion for labour and delivery. Anaesth Intensive Care. 2009 Jan;37(1):46-53. doi: 10.1177/0310057X0903700119.
PubMed 19157345Capogna G, Celleno D, Lyons G, Columb M, Fusco P. Minimum local analgesic concentration of extradural bupivacaine increases with progression of labour. Br J Anaesth. 1998 Jan;80(1):11-3. doi: 10.1093/bja/80.1.11.
PubMed 9505770Capogna G, Stirparo S. Techniques for the maintenance of epidural labor analgesia. Curr Opin Anaesthesiol. 2013 Jun;26(3):261-7. doi: 10.1097/ACO.0b013e328360b069.
PubMed 23563796Chua SM, Sia AT. Automated intermittent epidural boluses improve analgesia induced by intrathecal fentanyl during labour. Can J Anaesth. 2004 Jun-Jul;51(6):581-5. doi: 10.1007/BF03018402.
PubMed 15197122Goodman 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 19095858Boogmans T, Vertommen J, Valkenborgh T, Devroe S, Roofthooft E, Van de Velde M. Epidural neostigmine and clonidine improves the quality of combined spinal epidural analgesia in labour: a randomised, double-blind controlled trial. Eur J Anaesthesiol. 2014 Apr;31(4):190-6. doi: 10.1097/EJA.0b013e32836249e9.
PubMed 23959095
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Clinical Trial Comparing Programed Intermittent Epidural Boluses (PIEB) Versus Patient Controlled Epidural Analgesia (PCEA) With Epidural or Combined Spinal-epidural (CSE) Technique
- ClinicalTrials.gov ID
- NCT02768272
- Acronym / sponsor ID
- PIEB-CT / 2014-004696-24
- Conditions
- Labor Epidural Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 May 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.
The investigators have design a randomized double blind clinical trial to know the incidence of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early cervical dilation) comparing two epidural analgesic regimes: programed intermittent epidural boluses versus patient controlled epidural analgesia. The role of the epidural technique (epidural versus combined spinal-epidural) in the incidence of BP will be also evaluated.
Detailed description
Women in labor receiving epidural analgesia may experience breakthrough pain (BP) that requires the use of additional medication and that is a source of dissatisfaction with the analgesic treatment for labor.
The investigators can define two types of BP: 'primary breakthrough pain' is the first moment when the patient requests analgesia during labor. 'Secondary breakthrough pain' can be defined as the time a previously effective epidural analgesia turns ineffective.
The BP may have multiple causes, such as delivery progression and catheter misplacement. There is no single pattern to provide adequate neuraxial analgesia for labor, but for certain patients and specific clinical situations some methods provide advantages over others.
The choice of a suitable system of epidural drug delivery has an important role in getting proper analgesia and a low incidence of breakthrough pain during labor. In order to develop preventive strategies for BP, some clinical scales to estimate its incidence rate have been described. Among risk factors for BP the investigators can include: Nulliparity, epidural catheter placement at an earlier cervical dilation, neonatal weight and technique performed (epidural versus combined spinal-epidural - CSE).
In addition, technological development has offered us new treatment modalities of pain management during childbirth have evolved recently to improve maternal satisfaction, as well as to treat and prevent BP: Patient Controlled Epidural Analgesia (PCEA) added or not to a continuous epidural infusion (CEI), computer integrated PCEA (CI-PCEA) and automatic or programed intermittent epidural boluses (PIEB).
Nowadays, there is no evidence about the best epidural analgesic treatment or the optimum epidural punction in order to reduce BP episodes and, hence, increase maternal satisfaction.
Therefore, the investigators have design a randomized double blind clinical trial to know the incidence of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early cervical dilation) comparing two epidural analgesic regimes added to a contiuous infusion of L-bupivacaine plus fentanyl: programed intermittent epidural boluses versus patient controlled epidural analgesia. The role of the epidural technique (epidural versus combined spinal-epidural) in the incidence of BP will be also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia | Experimental | Device: PCEA vs PIEBRandomized allocation to receive patient controlled epidural analgesia or programed intermittent epidural boluses |
| Epidural technique | Experimental | Procedure: Epidural vs CSERandomized allocation to be punctioned a conventional epidural or a combined spinal-epidural technique |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 40 years
- Gestational age between 37 and 41 weeks
- Singleton pregnancies
- Nulliparity
- Spontaneous or induced labor
Key exclusion criteria (4 listed)
- Do not meet all the inclusion criteria
- Do not consent to the study
- Systemic medical pathologies as pre-eclampsia, insulin-treated gestational diabetes or multiple sclerosis that could influence medical decision during labour and/or make randomization unfeasible
- Contraindication for neuraxial analgesia
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 |
|---|---|---|
| PCEA vs PIEBWe evaluate the relation between the distribution of L-bupivacaine plus fentanyl in the epidural space and the incedence of breaktrough pain during labor | Device | Epidural analgesia |
| Epidural vs CSEWe evaluate the relation between the type of epidural technique and the incedence of breaktrough pain during labor | Procedure or surgery | Epidural technique |
Primary outcome
Incidence of breakthrough pain
Time frame: Labor
Evaluation of breakthough pain episodes since epidural punction to delivery
3 secondary outcomes
Total epidural infusion volume
Time frame: Labor
Incidence of epidural failure
Time frame: Labor
Mode of delivery (spontaneous, intrumental and cesarean section)
Time frame: Delivery
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 10 Aug 2017.
- Background: PubMed 11473872Hess PE, Pratt SD, Lucas TP, Miller CG, Corbett T, Oriol N, Sarna MC. Predictors of breakthrough pain during labor epidural analgesia. Anesth Analg. 2001 Aug;93(2):414-8, 4th contents page. doi: 10.1097/00000539-200108000-00036.
- Background: PubMed 21320088Loubert C, Hinova A, Fernando R. Update on modern neuraxial analgesia in labour: a review of the literature of the last 5 years. Anaesthesia. 2011 Mar;66(3):191-212. doi: 10.1111/j.1365-2044.2010.06616.x.
- Background: PubMed 12402726van der Vyver M, Halpern S, Joseph G. Patient-controlled epidural analgesia versus continuous infusion for labour analgesia: a meta-analysis. Br J Anaesth. 2002 Sep;89(3):459-65. doi: 10.1093/bja/aef217.
- Background: PubMed 17413923American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Practice guidelines for obstetric anesthesia: an updated report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Anesthesiology. 2007 Apr;106(4):843-63. doi: 10.1097/01.anes.0000264744.63275.10. No abstract available.
- Background: PubMed 11915061Hogan Q. Distribution of solution in the epidural space: examination by cryomicrotome section. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):150-6. doi: 10.1053/rapm.2002.29748.
- Background: PubMed 16492849Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. doi: 10.1213/01.ane.0000197778.57615.1a.
- Background: PubMed 19224805Halpern SH, Carvalho B. Patient-controlled epidural analgesia for labor. Anesth Analg. 2009 Mar;108(3):921-8. doi: 10.1213/ane.0b013e3181951a7f.
- Background: PubMed 15936187Stratmann G, Gambling DR, Moeller-Bertram T, Stackpole J, Pue AF, Berkowitz J. A randomized comparison of a five-minute versus fifteen-minute lockout interval for PCEA during labor. Int J Obstet Anesth. 2005 Jul;14(3):200-7. doi: 10.1016/j.ijoa.2004.12.008.
- Background: PubMed 17075662Sia AT, Lim Y, Ocampo CE. Computer-integrated patient-controlled epidural analgesia: a preliminary study on a novel approach of providing pain relief in labour. Singapore Med J. 2006 Nov;47(11):951-6.
- Background: PubMed 19157345Sng BL, Sia AT, Lim Y, Woo D, Ocampo C. Comparison of computer-integrated patient-controlled epidural analgesia and patient-controlled epidural analgesia with a basal infusion for labour and delivery. Anaesth Intensive Care. 2009 Jan;37(1):46-53. doi: 10.1177/0310057X0903700119.
- Background: PubMed 9505770Capogna G, Celleno D, Lyons G, Columb M, Fusco P. Minimum local analgesic concentration of extradural bupivacaine increases with progression of labour. Br J Anaesth. 1998 Jan;80(1):11-3. doi: 10.1093/bja/80.1.11.
- Background: PubMed 23563796Capogna G, Stirparo S. Techniques for the maintenance of epidural labor analgesia. Curr Opin Anaesthesiol. 2013 Jun;26(3):261-7. doi: 10.1097/ACO.0b013e328360b069.
- 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.
Emilia Guasch, MD, PhD principal investigator
Anesthesia and Intensive Care Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCEA vs PIEB and Epidural vs CSE in people with Labor Epidural Analgesia, run by Hospital Universitario La Paz at 1 site in Spain.
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 6 inclusion and 4 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 10 Aug 2017. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of breakthrough pain (time frame: Labor). 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 NCT02768272, which also lists 15 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 10 Aug 2017.