Clinical trial NCT01861821: 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
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Epidural catheter
Epidural analgesia
Labor epidural analgesia
Analgesic efficacy
Multiport epidural catheter
Uniport epidural catheter
Flexible epidural catheter
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
First posted: 2013-05-24
Enrollment: 650
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Analgesic success rate
timeFrame: 30 minutes following the initiation of labor epidural analgesia
Secondary outcomes:
measure: Inadequate analgesia at initiation of labor epidural analgesia
timeFrame: 30 minutes following the initiation of labor epidural analgesia
measure: Catheter replacement at initiation of labor epidural analgesia
timeFrame: 45 minutes following the initiation of labor epidural analgesia
measure: Adequate analgesia during the first stage of labor
timeFrame: The duration of first stage of labor, an expected average of 6 hours and 30 minutes
measure: Patient controlled epidural analgesia (PCEA) demands during the first stage of labor
timeFrame: The duration of first stage of labor, an expected average of 6 hours and 30 minutes
measure: Clinician interventions during the first stage of labor
timeFrame: The duration of first stage of labor, an expected average of 6 hours and 30 minutes
measure: Visual analogue scale (VAS) pain score at the time of clinician interventions during the first stage of labor
timeFrame: The duration of first stage of labor, an expected average of 6 hours and 30 minutes
measure: Catheter replacement during the first stage of labor
timeFrame: The duration of first stage of labor, an expected average of 6 hours and 30 minutes
measure: Adequate analgesia during the second stage of labor
timeFrame: The duration of second stage of labor, an expected average of 1 hour and 30 minutes
measure: Inadequate analgesia during the second stage of labor
timeFrame: The duration of second stage of labor, an expected average of 1 hour and 30 minutes
measure: Inadequate analgesia that failed epidural supplementation during the second stage of labor
timeFrame: The duration of second stage of labor, an expected average of 1 hour and 30 minutes
measure: Anesthetic success rate
timeFrame: 10 minutes following the initiation of epidural anesthesia for cesarean delivery
measure: Inadequate anesthesia at initiation of epidural anesthesia for cesarean delivery
timeFrame: 10 minutes following the initiation of epidural anesthesia for cesarean delivery
measure: Supplementation for breakthrough pain during maintenance of epidural anesthesia for cesarean delivery
timeFrame: The duration of cesarean delivery, an expected average of 50 minutes
measure: Difficult catheter insertion
timeFrame: The duration of epidural catheter placement, an expected average of 15 minutes
measure: Paresthesias
timeFrame: The duration of epidural catheter placement, an expected average of 15 minutes
measure: Intravascular cannulation
timeFrame: The duration of epidural catheter placement, an expected average of 15 minutes
measure: Intrathecal placement
timeFrame: The duration of epidural catheter placement, an expected average of 15 minutes
measure: Difficult catheter removal
timeFrame: The duration of epidural catheter removal, an expected average of 5 minutes
measure: Catheter breakage
timeFrame: The duration of epidural catheter removal, an expected average of 5 minutes
measure: Catheter wire uncoiling
timeFrame: The duration of epidural catheter removal, an expected average of 5 minutes
measure: Maternal satisfaction with the overall quality of analgesia/anesthesia during labor and delivery
timeFrame: 24 hours following delivery
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center
state: Texas
Study officials:
affiliation: Baylor Scott and White Health
name: John Philip, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Collier CB, Gatt SP. Epidural catheters for obstetrics. Terminal hole or lateral eyes? Reg Anesth. 1994 Nov-Dec;19(6):378-85.
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.
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.
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.
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.
citation: Hardy PA. Force exerted by epidural catheters. Anaesthesia. 1986 Mar;41(3):306-8. doi: 10.1111/j.1365-2044.1986.tb12794.x.
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.
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.
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.
citation: Asai T, Shingu K. Advantages and disadvantages of the Arrow FlexTip Plus epidural catheter. Anaesthesia. 2001 Jun;56(6):606. No abstract available.
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.
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.
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.
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.
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.
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.