PIEB vs PCEA With Epidural or CSE Technique. A Randomized Double Blind Clinical Trial

NCT02768272 | Completed Phase 4 DMC

• 1 other identifier: 2014-004696-24
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. The role of the epidural technique (epidural versus combined spinal-epidural) in the incidence of BP will be also evaluated.

Conditions

Labor Epidural Analgesia

Outcome Measures

Primary Outcomes (1)

• Incidence of breakthrough pain

  Evaluation of breakthough pain episodes since epidural punction to delivery

  Labor

Secondary Outcomes (3)

• Total epidural infusion volume

  Labor

• Incidence of epidural failure

  Labor

• Mode of delivery (spontaneous, intrumental and cesarean section)

  Delivery

Study Arms (2)

Epidural analgesia

EXPERIMENTAL

Randomized allocation to receive patient controlled epidural analgesia or programed intermittent epidural boluses

Device: PCEA vs PIEB

Epidural technique

EXPERIMENTAL

Randomized allocation to be punctioned a conventional epidural or a combined spinal-epidural technique

Procedure: Epidural vs CSE

Interventions

PCEA vs PIEB DEVICE

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 analgesia

Epidural vs CSE PROCEDURE

We evaluate the relation between the type of epidural technique and the incedence of breaktrough pain during labor

Epidural technique

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

University Hospital La Paz

Madrid, 28046, Spain

Location

Related Publications (15)

• 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.

  PMID: 11473872 BACKGROUND

• Loubert 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.

  PMID: 21320088 BACKGROUND

• van 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.

  PMID: 12402726 BACKGROUND

• American 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.

  PMID: 17413923 BACKGROUND

• Hogan 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.

  PMID: 11915061 BACKGROUND

• Wong 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.

  PMID: 16492849 BACKGROUND

• Halpern SH, Carvalho B. Patient-controlled epidural analgesia for labor. Anesth Analg. 2009 Mar;108(3):921-8. doi: 10.1213/ane.0b013e3181951a7f.

  PMID: 19224805 BACKGROUND

• Stratmann 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.

  PMID: 15936187 BACKGROUND

• Sia 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.

  PMID: 17075662 BACKGROUND

• Sng 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.

  PMID: 19157345 BACKGROUND

• Capogna 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.

  PMID: 9505770 BACKGROUND

• Capogna 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.

  PMID: 23563796 BACKGROUND

• Chua 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.

  PMID: 15197122 BACKGROUND

• Goodman 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.

  PMID: 19095858 BACKGROUND

• Boogmans 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.

  PMID: 23959095 BACKGROUND

Study Officials

• Emilia Guasch, MD, PhD

  Anesthesia and Intensive Care Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Anesthesia and Intensive Care Department

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 11, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)