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

Labor Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861821
• Other study ID #: 010-158
• Status: Completed
• Phase: N/A
• First received: June 1, 2012
• Last updated: August 5, 2015
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2015
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• Multiport flexible catheter
Multiport flexible catheter has three ports for the delivery of epidural medication
• Uniport flexible catheter
Uniport flexible catheter has one port for the delivery of epidural medication

Locations

Country	Name	City	State
United States	Baylor All Saints Medical Center	Fort Worth	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View Citation

Asai T, Shingu K. Advantages and disadvantages of the Arrow FlexTip Plus epidural catheter. Anaesthesia. 2001 Jun;56(6):606. — View 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. — View 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. — View 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):554-5. — View 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. — View Citation

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

Hardy PA. Force exerted by epidural catheters. Anaesthesia. 1986 Mar;41(3):306-8. — View Citation

Hogan Q. Epidural catheter tip position and distribution of injectate evaluated by computed tomography. Anesthesiology. 1999 Apr;90(4):964-70. — View 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. — View 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. — View 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. — View 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. — View Citation

Pierre HL, Block BM, Wu CL. Difficult removal of a wire-reinforced epidural catheter. J Clin Anesth. 2003 Mar;15(2):140-1. — View 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. — View 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. — View Citation

Woehlck HJ, Bolla B. Uncoiling of wire in arrow flextip epidural catheter on removal. Anesthesiology. 2000 Mar;92(3):907-9. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic success rate	Incidence of adequate analgesia at initiation of labor epidural analgesia	30 minutes following the initiation of labor epidural analgesia	No
Secondary	Inadequate analgesia at initiation of labor epidural analgesia		30 minutes following the initiation of labor epidural analgesia	No
Secondary	Catheter replacement at initiation of labor epidural analgesia		45 minutes following the initiation of labor epidural analgesia	No
Secondary	Adequate analgesia during the first stage of labor	Determined from patients receiving patient controlled epidural analgesia (PCEA) who do not require clinician interventions	The duration of first stage of labor, an expected average of 6 hours and 30 minutes	No
Secondary	Patient controlled epidural analgesia (PCEA) demands during the first stage of labor		The duration of first stage of labor, an expected average of 6 hours and 30 minutes	No
Secondary	Clinician interventions during the first stage of labor		The duration of first stage of labor, an expected average of 6 hours and 30 minutes	No
Secondary	Visual analogue scale (VAS) pain score at the time 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	No
Secondary	Catheter replacement during the first stage of labor		The duration of first stage of labor, an expected average of 6 hours and 30 minutes	No
Secondary	Adequate analgesia during the second stage of labor		The duration of second stage of labor, an expected average of 1 hour and 30 minutes	No
Secondary	Inadequate analgesia during the second stage of labor		The duration of second stage of labor, an expected average of 1 hour and 30 minutes	No
Secondary	Inadequate analgesia that failed epidural supplementation during the second stage of labor		The duration of second stage of labor, an expected average of 1 hour and 30 minutes	No
Secondary	Anesthetic success rate	Incidence of adequate anesthesia at initiation of epidural anesthesia for cesarean delivery	10 minutes following the initiation of epidural anesthesia for cesarean delivery	No
Secondary	Inadequate anesthesia at initiation of epidural anesthesia for cesarean delivery		10 minutes following the initiation of epidural anesthesia for cesarean delivery	No
Secondary	Supplementation for breakthrough pain during maintenance of epidural anesthesia for cesarean delivery		The duration of cesarean delivery, an expected average of 50 minutes	No
Secondary	Difficult catheter insertion		The duration of epidural catheter placement, an expected average of 15 minutes	Yes
Secondary	Paresthesias		The duration of epidural catheter placement, an expected average of 15 minutes	Yes
Secondary	Intravascular cannulation		The duration of epidural catheter placement, an expected average of 15 minutes	Yes
Secondary	Intrathecal placement		The duration of epidural catheter placement, an expected average of 15 minutes	Yes
Secondary	Difficult catheter removal		The duration of epidural catheter removal, an expected average of 5 minutes	Yes
Secondary	Catheter breakage		The duration of epidural catheter removal, an expected average of 5 minutes	Yes
Secondary	Catheter wire uncoiling		The duration of epidural catheter removal, an expected average of 5 minutes	Yes
Secondary	Maternal satisfaction with the overall quality of analgesia/anesthesia during labor and delivery		24 hours following delivery	No