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

Labor Epidural Analgesia Clinical Trial

— PIEB-CT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768272
• Other study ID #: 2014-004696-24
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2016
• Last updated: August 9, 2017
• Start date: March 1, 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 40 years

2. Gestational age between 37 and 41 weeks

3. Singleton pregnancies

4. Nulliparity

5. Spontaneous or induced labor

6. Cervical dilation less than four centimeters

Exclusion Criteria:

1. Do not meet all the inclusion criteria

2. Do not consent to the study

3. 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

4. Contraindication for neuraxial analgesia

Related Conditions & MeSH terms

• Labor Epidural Analgesia

Intervention

Device:
• PCEA vs PIEB
We evaluate the relation between the distribution of L-bupivacaine plus fentanyl in the epidural space and the incedence of breaktrough pain during labor

Procedure:
• Epidural vs CSE
We evaluate the relation between the type of epidural technique and the incedence of breaktrough pain during labor

Locations

Country	Name	City	State
Spain	University Hospital La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Hogan Q. Distribution of solution in the epidural space: examination by cryomicrotome section. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):150-6. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of breakthrough pain	Evaluation of breakthough pain episodes since epidural punction to delivery	Labor
Secondary	Total epidural infusion volume	Measurement of the total epidural infusion volume administered to the patient	Labor
Secondary	Incidence of epidural failure	Assesment the incidence of failed epdirual technique	Labor
Secondary	Mode of delivery (spontaneous, intrumental and cesarean section)	Analysis of the potential relation of the interventions with the type of delivery	Delivery