NCT01861821

Brief Summary

The purpose of this study is to determine whether multiple ports improve the analgesic efficacy of flexible catheters used for the provision of epidural analgesia during the entire continuum of labor and delivery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2012

Completed
12 months until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 7, 2025

Status Verified

September 1, 2016

Enrollment Period

1.6 years

First QC Date

June 1, 2012

Last Update Submit

October 1, 2025

Conditions

Labor Pain

Keywords

Epidural catheterEpidural analgesiaLabor epidural analgesiaAnalgesic efficacyMultiport epidural catheterUniport epidural catheterFlexible epidural catheter

Outcome Measures

Primary Outcomes (1)

  • Analgesic success rate

    Complete analgesia is defined as the complete relief of pain during contractions following the administration of the above epidural medication without requiring further epidural medication/intervention.

    30 minutes following the initiation of labor epidural analgesia

Secondary Outcomes (3)

  • Number of Clinician interventions during the first stage of labor

    The duration of first stage of labor, an expected average of 6 hours and 30 minutes

  • Anesthetic success rate

    10 minutes following the initiation of epidural anesthesia for cesarean delivery

  • Maternal satisfaction with the overall quality of analgesia/anesthesia during labor and delivery

    24 hours following delivery

Study Arms (2)

Multiport flexible catheter

ACTIVE COMPARATOR

Multiport flexible catheter has three ports for the delivery of epidural medication for labor analgesia

Device: Multiport flexible catheter

Uniport flexible catheter

ACTIVE COMPARATOR

Uniport flexible catheter has one port for the delivery of epidural medication for labor analgesia

Device: Uniport flexible catheter

Interventions

Multiport flexible catheterDEVICE

Multiport flexible catheter has three ports for the delivery of epidural medication

Multiport flexible catheter
Uniport flexible catheterDEVICE

Uniport flexible catheter has one port for the delivery of epidural medication

Uniport flexible catheter

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists Classification I-III parturients
  • Mixed parity
  • Estimated gestational age of at least 37 weeks
  • Singleton gestation
  • Cephalic presentation
  • Spontaneous or induced labor

You may not qualify if:

  • Body mass index (BMI) \> 45 kg/m2
  • Prior cesarean section
  • Multiple gestation
  • Fetal abnormality
  • Use of chronic analgesic medication
  • Local anesthetic allergy
  • Coagulopathy or anticoagulation
  • Infection at epidural insertion site
  • Spinal deformity other than mild scoliosis
  • Uncontrolled/uncompensated/uncorrected cerebral, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrinologic, metabolic, or hematologic condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor All Saints Medical Center

Fort Worth, Texas, 76104, United States

Location

Related Publications (18)

  • D'Angelo R, Foss ML, Livesay CH. A comparison of multiport and uniport epidural catheters in laboring patients. Anesth Analg. 1997 Jun;84(6):1276-9. doi: 10.1097/00000539-199706000-00019.

    PMID: 9174306BACKGROUND

  • Segal S, Eappen S, Datta S. Superiority of multi-orifice over single-orifice epidural catheters for labor analgesia and cesarean delivery. J Clin Anesth. 1997 Mar;9(2):109-12. doi: 10.1016/S0952-8180(97)00232-8.

    PMID: 9075034BACKGROUND

  • Collier CB, Gatt SP. Epidural catheters for obstetrics. Terminal hole or lateral eyes? Reg Anesth. 1994 Nov-Dec;19(6):378-85.

    PMID: 7848946BACKGROUND

  • Michael S, Richmond MN, Birks RJ. A comparison between open-end (single hole) and closed-end (three lateral holes) epidural catheters. Complications and quality of sensory blockade. Anaesthesia. 1989 Jul;44(7):578-80. doi: 10.1111/j.1365-2044.1989.tb11446.x.

    PMID: 2774123BACKGROUND

  • Jaime F, Mandell GL, Vallejo MC, Ramanathan S. Uniport soft-tip, open-ended catheters versus multiport firm-tipped close-ended catheters for epidural labor analgesia: a quality assurance study. J Clin Anesth. 2000 Mar;12(2):89-93. doi: 10.1016/s0952-8180(00)00116-1.

    PMID: 10818320BACKGROUND

  • Banwell BR, Morley-Forster P, Krause R. Decreased incidence of complications in parturients with the arrow (FlexTip Plus) epidural catheter. Can J Anaesth. 1998 Apr;45(4):370-2. doi: 10.1007/BF03012031.

    PMID: 9597214BACKGROUND

  • Spiegel JE, Vasudevan A, Li Y, Hess PE. A randomized prospective study comparing two flexible epidural catheters for labour analgesia. Br J Anaesth. 2009 Sep;103(3):400-5. doi: 10.1093/bja/aep174. Epub 2009 Jun 27.

    PMID: 19561345BACKGROUND

  • Hardy PA. Force exerted by epidural catheters. Anaesthesia. 1986 Mar;41(3):306-8. doi: 10.1111/j.1365-2044.1986.tb12794.x.

    PMID: 3963335BACKGROUND

  • Hogan Q. Epidural catheter tip position and distribution of injectate evaluated by computed tomography. Anesthesiology. 1999 Apr;90(4):964-70. doi: 10.1097/00000542-199904000-00006.

    PMID: 10201664BACKGROUND

  • McAtamney D, O'Hare C, Fee JP. An in vitro evaluation of flow from multihole epidural catheters during continuous infusion with four different infusion pumps. Anaesthesia. 1999 Jul;54(7):664-9. doi: 10.1046/j.1365-2044.1999.00892.x.

    PMID: 10417459BACKGROUND

  • Chiron B, de Serres TM, Fusciardi J, Laffon M. Difficult Removal of an Arrow FlexTip Plus epidural catheter. Anesth Analg. 2008 Sep;107(3):1085-6. doi: 10.1213/ane.0b013e31817e038b. No abstract available.

    PMID: 18713938BACKGROUND

  • Asai T, Shingu K. Advantages and disadvantages of the Arrow FlexTip Plus epidural catheter. Anaesthesia. 2001 Jun;56(6):606. No abstract available.

    PMID: 11412201BACKGROUND

  • Hopf B, Leischik M. More on problems with removing the arrow FlexTip epidural catheter: smooth in-hardly out? Anesthesiology. 2000 Nov;93(5):1362. doi: 10.1097/00000542-200011000-00037. No abstract available.

    PMID: 11046232BACKGROUND

  • Asai T, Sakai T, Murao K, Kojima K, Shingu K. More difficulty in removing an arrow epidural catheter. Anesth Analg. 2006 May;102(5):1595-6. doi: 10.1213/01.ANE.0000215172.96873.43. No abstract available.

    PMID: 16632862BACKGROUND

  • Asai T, Yamamoto K, Hirose T, Taguchi H, Shingu K. Breakage of epidural catheters: a comparison of an arrow reinforced catheter and other nonreinforced catheters. Anesth Analg. 2001 Jan;92(1):246-8. doi: 10.1097/00000539-200101000-00048. No abstract available.

    PMID: 11133637BACKGROUND

  • Bastien JL, McCarroll MG, Everett LL. Uncoiling of Arrow Flextip plus epidural catheter reinforcing wire during catheter removal: an unusual complication. Anesth Analg. 2004 Feb;98(2):554-555. doi: 10.1213/01.ANE.0000077718.21575.F6. No abstract available.

    PMID: 14742413BACKGROUND

  • Pierre HL, Block BM, Wu CL. Difficult removal of a wire-reinforced epidural catheter. J Clin Anesth. 2003 Mar;15(2):140-1. doi: 10.1016/s0952-8180(02)00516-0.

    PMID: 12719055BACKGROUND

  • Woehlck HJ, Bolla B. Uncoiling of wire in arrow flextip epidural catheter on removal. Anesthesiology. 2000 Mar;92(3):907-9. doi: 10.1097/00000542-200003000-00058. No abstract available.

    PMID: 10719987BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John Philip, MD

    Baylor Scott and White Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2012

First Posted

May 24, 2013

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 7, 2025

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)