Back to resultsAnalgesic Efficacy of a Multiport Versus Uniport Flexible Catheter for Labor Epidural Analgesia
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multiport flexible catheter
Uniport flexible catheter
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring Epidural catheter, Epidural analgesia, Labor epidural analgesia, Analgesic efficacy, Multiport epidural catheter, Uniport epidural catheter, Flexible epidural catheter
Eligibility Criteria
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:
- 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
Sites / Locations
- Baylor All Saints Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Multiport flexible catheter
Uniport flexible catheter
Arm Description
Multiport flexible catheter has three ports for the delivery of epidural medication for labor analgesia
Uniport flexible catheter has one port for the delivery of epidural medication for labor analgesia
Outcomes
Primary Outcome Measures
Analgesic success rate
Incidence of adequate analgesia at initiation of labor epidural analgesia
Secondary Outcome Measures
Inadequate analgesia at initiation of labor epidural analgesia
Catheter replacement at initiation of labor epidural analgesia
Adequate analgesia during the first stage of labor
Determined from patients receiving patient controlled epidural analgesia (PCEA) who do not require clinician interventions
Patient controlled epidural analgesia (PCEA) demands during the first stage of labor
Clinician interventions during the first stage of labor
Visual analogue scale (VAS) pain score at the time of clinician interventions during the first stage of labor
Catheter replacement during the first stage of labor
Adequate analgesia during the second stage of labor
Inadequate analgesia during the second stage of labor
Inadequate analgesia that failed epidural supplementation during the second stage of labor
Anesthetic success rate
Incidence of adequate anesthesia at initiation of epidural anesthesia for cesarean delivery
Inadequate anesthesia at initiation of epidural anesthesia for cesarean delivery
Supplementation for breakthrough pain during maintenance of epidural anesthesia for cesarean delivery
Difficult catheter insertion
Paresthesias
Intravascular cannulation
Intrathecal placement
Difficult catheter removal
Catheter breakage
Catheter wire uncoiling
Maternal satisfaction with the overall quality of analgesia/anesthesia during labor and delivery
Full Information
NCT ID
NCT01861821
First Posted
June 1, 2012
Last Updated
August 5, 2015
Sponsor
Baylor Research Institute
Collaborators
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01861821
Brief Title
Analgesic Efficacy of a Multiport Versus Uniport Flexible Catheter for Labor Epidural Analgesia
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Epidural catheter, Epidural analgesia, Labor epidural analgesia, Analgesic efficacy, Multiport epidural catheter, Uniport epidural catheter, Flexible epidural catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
650 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multiport flexible catheter
Arm Type
Active Comparator
Arm Description
Multiport flexible catheter has three ports for the delivery of epidural medication for labor analgesia
Arm Title
Uniport flexible catheter
Arm Type
Active Comparator
Arm Description
Uniport flexible catheter has one port for the delivery of epidural medication for labor analgesia
Intervention Type
Device
Intervention Name(s)
Multiport flexible catheter
Intervention Description
Multiport flexible catheter has three ports for the delivery of epidural medication
Intervention Type
Device
Intervention Name(s)
Uniport flexible catheter
Intervention Description
Uniport flexible catheter has one port for the delivery of epidural medication
Primary Outcome Measure Information:
Title
Analgesic success rate
Description
Incidence of adequate analgesia at initiation of labor epidural analgesia
Time Frame
30 minutes following the initiation of labor epidural analgesia
Secondary Outcome Measure Information:
Title
Inadequate analgesia at initiation of labor epidural analgesia
Time Frame
30 minutes following the initiation of labor epidural analgesia
Title
Catheter replacement at initiation of labor epidural analgesia
Time Frame
45 minutes following the initiation of labor epidural analgesia
Title
Adequate analgesia during the first stage of labor
Description
Determined from patients receiving patient controlled epidural analgesia (PCEA) who do not require clinician interventions
Time Frame
The duration of first stage of labor, an expected average of 6 hours and 30 minutes
Title
Patient controlled epidural analgesia (PCEA) demands during the first stage of labor
Time Frame
The duration of first stage of labor, an expected average of 6 hours and 30 minutes
Title
Clinician interventions during the first stage of labor
Time Frame
The duration of first stage of labor, an expected average of 6 hours and 30 minutes
Title
Visual analogue scale (VAS) pain score at the time of clinician interventions during the first stage of labor
Time Frame
The duration of first stage of labor, an expected average of 6 hours and 30 minutes
Title
Catheter replacement during the first stage of labor
Time Frame
The duration of first stage of labor, an expected average of 6 hours and 30 minutes
Title
Adequate analgesia during the second stage of labor
Time Frame
The duration of second stage of labor, an expected average of 1 hour and 30 minutes
Title
Inadequate analgesia during the second stage of labor
Time Frame
The duration of second stage of labor, an expected average of 1 hour and 30 minutes
Title
Inadequate analgesia that failed epidural supplementation during the second stage of labor
Time Frame
The duration of second stage of labor, an expected average of 1 hour and 30 minutes
Title
Anesthetic success rate
Description
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
Title
Inadequate anesthesia at initiation of epidural anesthesia for cesarean delivery
Time Frame
10 minutes following the initiation of epidural anesthesia for cesarean delivery
Title
Supplementation for breakthrough pain during maintenance of epidural anesthesia for cesarean delivery
Time Frame
The duration of cesarean delivery, an expected average of 50 minutes
Title
Difficult catheter insertion
Time Frame
The duration of epidural catheter placement, an expected average of 15 minutes
Title
Paresthesias
Time Frame
The duration of epidural catheter placement, an expected average of 15 minutes
Title
Intravascular cannulation
Time Frame
The duration of epidural catheter placement, an expected average of 15 minutes
Title
Intrathecal placement
Time Frame
The duration of epidural catheter placement, an expected average of 15 minutes
Title
Difficult catheter removal
Time Frame
The duration of epidural catheter removal, an expected average of 5 minutes
Title
Catheter breakage
Time Frame
The duration of epidural catheter removal, an expected average of 5 minutes
Title
Catheter wire uncoiling
Time Frame
The duration of epidural catheter removal, an expected average of 5 minutes
Title
Maternal satisfaction with the overall quality of analgesia/anesthesia during labor and delivery
Time Frame
24 hours following delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Philip, MD
Organizational Affiliation
Baylor Scott and White Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor All Saints Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9174306
Citation
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.
Results Reference
background
PubMed Identifier
9075034
Citation
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.
Results Reference
background
PubMed Identifier
7848946
Citation
Collier CB, Gatt SP. Epidural catheters for obstetrics. Terminal hole or lateral eyes? Reg Anesth. 1994 Nov-Dec;19(6):378-85.
Results Reference
background
PubMed Identifier
2774123
Citation
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.
Results Reference
background
PubMed Identifier
10818320
Citation
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.
Results Reference
background
PubMed Identifier
9597214
Citation
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.
Results Reference
background
PubMed Identifier
19561345
Citation
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.
Results Reference
background
PubMed Identifier
3963335
Citation
Hardy PA. Force exerted by epidural catheters. Anaesthesia. 1986 Mar;41(3):306-8. doi: 10.1111/j.1365-2044.1986.tb12794.x.
Results Reference
background
PubMed Identifier
10201664
Citation
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.
Results Reference
background
PubMed Identifier
10417459
Citation
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.
Results Reference
background
PubMed Identifier
18713938
Citation
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.
Results Reference
background
PubMed Identifier
11412201
Citation
Asai T, Shingu K. Advantages and disadvantages of the Arrow FlexTip Plus epidural catheter. Anaesthesia. 2001 Jun;56(6):606. No abstract available.
Results Reference
background
PubMed Identifier
11046232
Citation
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.
Results Reference
background
PubMed Identifier
16632862
Citation
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.
Results Reference
background
PubMed Identifier
11133637
Citation
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.
Results Reference
background
PubMed Identifier
14742413
Citation
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.
Results Reference
background
PubMed Identifier
12719055
Citation
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.
Results Reference
background
PubMed Identifier
10719987
Citation
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.
Results Reference
background
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Analgesic Efficacy of a Multiport Versus Uniport Flexible Catheter for Labor Epidural Analgesia
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