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Labor PainNCT01861821

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

A study testing Multiport flexible catheter and Uniport flexible catheter in people with Labor Pain, run by Baylor Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Labor Pain
What is being tested?
Multiport flexible catheter and Uniport flexible catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
1 siteUnited States
Study dates
Nov 2011to Jun 2013
Phase
Interventional
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 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Body mass index (BMI) > 45 kg/m2
  • Prior cesarean section
  • Multiple gestation
  • Fetal abnormality
  • Use of chronic analgesic medication
  • Local anesthetic allergy
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor All Saints Medical Center

    Fort Worth, Texas, 76104

Other trials in United States

About this study

Official title: Prospective, Controlled, Randomized, Blinded, Single-center Study of the Clinical Efficacy and Outcomes of a Multiport Versus Uniport Flexible Catheter for Epidural Analgesia During Labor and Delivery

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

Conditions
Labor Pain
Being tested
Multiport flexible catheter, Uniport flexible catheter
Keywords
Epidural catheter, Epidural analgesia, Labor epidural analgesia, Analgesic efficacy, Multiport epidural catheter, Uniport epidural catheter, Flexible epidural catheter
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multiport flexible catheterDevice

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

  • Uniport flexible catheterDevice

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

Study groups in NCT01861821
Study groupRoleWhat they receive
Multiport flexible catheterActive comparatorMultiport flexible catheter has three ports for the delivery of epidural medication for labor analgesia
Receives: Device: Multiport flexible catheter
Uniport flexible catheterActive comparatorUniport flexible catheter has one port for the delivery of epidural medication for labor analgesia
Receives: Device: Uniport flexible catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 minutes following the initiation of labor epidural analgesia

Secondary outcomes (3)

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

    Clinician administered rescue epidural boluses during first stage of labor

    Measured: 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

    Measured: 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

    Measured: 24 hours following delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2013 (estimated)
  2. Study startNov 2011
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01861821
Sponsor's protocol ID
010-158
Status last verified
Sep 2016
First submitted
1 Jun 2012
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Multiport flexible catheter and Uniport flexible catheter in people with Labor Pain, run by Baylor Research Institute at 1 site in United States.

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 10 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 7 Oct 2025. 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 United States. 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.

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?

Analgesic success rate (time frame: 30 minutes following the initiation of labor epidural analgesia). 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 NCT01861821, which also lists 18 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 7 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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