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CompletedNCT01861821Updated Oct 7, 2025

Analgesic Efficacy of a Multiport Versus Uniport Flexible Catheter for Labor Epidural Analgesia

An interventional study of Multiport flexible catheter and Uniport flexible catheter in Labor Pain, sponsored by Baylor Research Institute. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-10-07.

Sponsored by Baylor Research Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
650
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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

Read the detailed description

Multiport catheters, when compared to uniport catheters, have been associated with better analgesic quality during labor epidural analgesia because the presence of more than one port may enhance the distribution of epidural medication

Flexible catheters, when compared to rigid catheters, have been associated with better analgesic quality during labor epidural analgesia because greater flexibility may minimize catheter deviation in the epidural space, facilitate more optimal catheter placement in the epidural space, and result in better distribution of epidural medication

It is unknown whether multiple ports, which promote better distribution of epidural medication, provide added analgesic benefit to flexible catheters, which also facilitate better distribution of epidural medication, when used for the provision of epidural analgesia during labor and delivery

02

Conditions studied

  • Labor Pain

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Keywords

  • Epidural catheter
  • Epidural analgesia
  • Labor epidural analgesia
  • Analgesic efficacy
  • Multiport epidural catheter
  • Uniport epidural catheter
  • Flexible epidural catheter
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In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 650 is above the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Baylor Research Institute is the lead sponsor of 219 studies on the registry; 49 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
650 participants (actual)

Study arms

  • Active comparator
    Multiport flexible catheter

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

    Device: Multiport flexible catheter

  • Active comparator
    Uniport flexible catheter

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

    Device: Uniport flexible catheter

Interventions

  • DeviceMultiport flexible catheter

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

  • DeviceUniport flexible catheter

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

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What researchers measure

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.

    Time frame: 30 minutes following the initiation of labor epidural analgesia

Secondary outcomes

  1. Number of Clinician interventions during the first stage of labor

    Clinician administered rescue epidural boluses during first stage of labor

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

  2. Anesthetic success rate

    Incidence of adequate anesthesia at initiation of epidural anesthesia for cesarean delivery

    Time frame: 10 minutes following the initiation of epidural anesthesia for cesarean delivery

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

    Subjects will be asked to evaluate the quality of labor and delivery analgesia/anesthesia as: Poor, Fair, Good, Very good, Excellent

    Time frame: 24 hours following delivery

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Study locations

1 site
  • Baylor All Saints Medical Center
    Fort Worth, Texas 76104, United States
08

References and documents

Publications

  • 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. PubMed 9174306 ↗
  • 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. PubMed 9075034 ↗
  • Collier CB, Gatt SP. Epidural catheters for obstetrics. Terminal hole or lateral eyes? Reg Anesth. 1994 Nov-Dec;19(6):378-85. PubMed 7848946 ↗
  • 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. PubMed 2774123 ↗
  • 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. PubMed 10818320 ↗
  • 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. PubMed 9597214 ↗
  • 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. PubMed 19561345 ↗
  • Hardy PA. Force exerted by epidural catheters. Anaesthesia. 1986 Mar;41(3):306-8. doi: 10.1111/j.1365-2044.1986.tb12794.x. PubMed 3963335 ↗
  • 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. PubMed 10201664 ↗
  • 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. PubMed 10417459 ↗
  • 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. PubMed 18713938 ↗
  • Asai T, Shingu K. Advantages and disadvantages of the Arrow FlexTip Plus epidural catheter. Anaesthesia. 2001 Jun;56(6):606. No abstract available. PubMed 11412201 ↗
  • 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. PubMed 11046232 ↗
  • 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. PubMed 16632862 ↗
  • 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. PubMed 11133637 ↗
  • 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. PubMed 14742413 ↗
  • 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. PubMed 12719055 ↗
  • 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. PubMed 10719987 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01861821
Lead sponsor
Baylor Research Institute
Collaborators
University of Texas Southwestern Medical Center
Responsible party
Sponsor
First posted
May 24, 2013
Start date
Nov 2011
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Oct 7, 2025

Study contacts

John Philip, MD
principal investigator · Baylor Scott and White Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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