Effects of Analgesic Techniques on Duration of Spontaneously Laboring Patients

NCT01982838 | Terminated

• 1 other identifier: STU00031086
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if there is a difference in the duration of the first stage of labor in nulliparous women in spontaneous labor with whom analgesia is maintained with a combined spinal epidural (CSE) technique versus nulliparous women in spontaneous labor with whom an epidural de novo technique is utilized. The investigators hypothesize that the duration of the first stage of labor will be no different in nulliparous patients who receive either intrathecal fentanyl or intrathecal fentanyl and bupivacaine, as part of a CSE technique. However, the duration of the first stage of labor will be shorter in parturients who receive intrathecal analgesia (as part of a CSE technique) compared to those who receive an epidural de novo technique with fentanyl and bupivacaine.

Conditions

Effects of; Anesthesia, in Labor and Delivery; Pregnancy; Prolonged First Stage of Labor

Keywords

pain; epidural; combined spinal epidural

Outcome Measures

Primary Outcomes (1)

• Duration of first stage of labor

  Sterile cervical examinations at the first request for labor analgesia will be done, then at routine times during the course of labor per the managing OB provider's discretion. When the patient reaches 90-100% cervical effacement, cervical exams will be done every two hours thereafter until the patient reaches complete cervical dilation. Cervical examinations will be performed using a sterile glove, by each patient's labor and delivery nurse or physician.

  Onset of contractions or spontaneous rupture of membrances to cervical dilation of 10cm

Secondary Outcomes (1)

• Presence or absence of fetal heart rate decelerations

  time of first analgesic dose - 60 minutes

Study Arms (3)

Group E

ACTIVE COMPARATOR

Epidural de novo technique

Procedure: Epidural de novo

Group BF

ACTIVE COMPARATOR

Combined spinal epidural (CSE) technique with intrathecal 0.5% Bupivicaine 2.5mg + Fentanyl 15mcg

Procedure: CSE

Group F

ACTIVE COMPARATOR

Combined spinal epidural (CSE) technique with intrathecal fentanyl 25mcg

Procedure: CSE

Interventions

Epidural de novo PROCEDURE

Patients will have the epidural space identified with a loss-of-resistance technique utilizing a 17-G Tuohy epidural needle. The epidural catheter will be inserted 5 cm into the epidural space. Epidural analgesia will be initiated with fentanyl 100mcg + bupivacaine 0.125% 10-20 mL (in divided doses). Maintenance epidural analgesia will then be initiated.

Group E

CSE PROCEDURE

The epidural space will be located using the loss-of-resistance technique utilizing a 17-G Tuohy epidural needle. Patients will receive the intrathecal study drug via a 27-G pencil-point spinal needle utilizing the standard needle-through-needle technique. A 19-G epidural catheter will be inserted 5 cm in the epidural space. Maintenance epidural analgesia will then be initiated.

Group BF; Group F

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous,
• American Society of Anesthesia Physical Status (ASA) 2 females
• \>18 years-old
• term (\>37 weeks gestation)
• singleton
• vertex pregnancies
• spontaneous labor or spontaneous rupture of membranes

You may not qualify if:

• Non-vertex presentation
• induction of labor
• contraindication to opioid or neuraxial analgesia
• contraindication to combine spinal-epidural technique (e.g. unfavorable airway exam)
• cervical dilation \> 4.0 cm
• administration of systemic hydromorphone within 4 hours of epidural request

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memoral Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (26)

• Howell CJ, Chalmers I. A review of prospectively controlled comparisons of epidural with non-epidural forms of pain relief during labour. Int J Obstet Anesth. 1992 Jan;1(2):93-110. doi: 10.1016/0959-289x(92)90008-r.

  PMID: 15636806 BACKGROUND

• Ramin SM, Gambling DR, Lucas MJ, Sharma SK, Sidawi JE, Leveno KJ. Randomized trial of epidural versus intravenous analgesia during labor. Obstet Gynecol. 1995 Nov;86(5):783-9. doi: 10.1016/0029-7844(95)00269-w.

  PMID: 7566849 BACKGROUND

• Herman NL, Choi KC, Affleck PJ, Calicott R, Brackin R, Singhal A, Andreasen A, Gadalla F, Fong J, Gomillion MC, Hartman JK, Koff HD, Lee SH, Van Decar TK. Analgesia, pruritus, and ventilation exhibit a dose-response relationship in parturients receiving intrathecal fentanyl during labor. Anesth Analg. 1999 Aug;89(2):378-83. doi: 10.1097/00000539-199908000-00024.

  PMID: 10439751 BACKGROUND

• Stocks GM, Hallworth SP, Fernando R, England AJ, Columb MO, Lyons G. Minimum local analgesic dose of intrathecal bupivacaine in labor and the effect of intrathecal fentanyl. Anesthesiology. 2001 Apr;94(4):593-8; discussion 5A. doi: 10.1097/00000542-200104000-00011.

  PMID: 11379678 BACKGROUND

• Ohel G, Gonen R, Vaida S, Barak S, Gaitini L. Early versus late initiation of epidural analgesia in labor: does it increase the risk of cesarean section? A randomized trial. Am J Obstet Gynecol. 2006 Mar;194(3):600-5. doi: 10.1016/j.ajog.2005.10.821.

  PMID: 16522386 BACKGROUND

• Wong CA, Scavone BM, Peaceman AM, McCarthy RJ, Sullivan JT, Diaz NT, Yaghmour E, Marcus RJ, Sherwani SS, Sproviero MT, Yilmaz M, Patel R, Robles C, Grouper S. The risk of cesarean delivery with neuraxial analgesia given early versus late in labor. N Engl J Med. 2005 Feb 17;352(7):655-65. doi: 10.1056/NEJMoa042573.

  PMID: 15716559 BACKGROUND

• Wong CA, McCarthy RJ, Sullivan JT, Scavone BM, Gerber SE, Yaghmour EA. Early compared with late neuraxial analgesia in nulliparous labor induction: a randomized controlled trial. Obstet Gynecol. 2009 May;113(5):1066-1074. doi: 10.1097/AOG.0b013e3181a1a9a8.

  PMID: 19384122 BACKGROUND

• Sharma SK, McIntire DD, Wiley J, Leveno KJ. Labor analgesia and cesarean delivery: an individual patient meta-analysis of nulliparous women. Anesthesiology. 2004 Jan;100(1):142-8; discussion 6A. doi: 10.1097/00000542-200401000-00023.

  PMID: 14695735 BACKGROUND

• Comparative Obstetric Mobile Epidural Trial (COMET) Study Group UK. Effect of low-dose mobile versus traditional epidural techniques on mode of delivery: a randomised controlled trial. Lancet. 2001 Jul 7;358(9275):19-23. doi: 10.1016/S0140-6736(00)05251-X.

  PMID: 11454372 BACKGROUND

• Nageotte MP, Larson D, Rumney PJ, Sidhu M, Hollenbach K. Epidural analgesia compared with combined spinal-epidural analgesia during labor in nulliparous women. N Engl J Med. 1997 Dec 11;337(24):1715-9. doi: 10.1056/NEJM199712113372402.

  PMID: 9392696 BACKGROUND

• Norris MC, Fogel ST, Conway-Long C. Combined spinal-epidural versus epidural labor analgesia. Anesthesiology. 2001 Oct;95(4):913-20. doi: 10.1097/00000542-200110000-00020.

  PMID: 11605932 BACKGROUND

• Tsen LC, Thue B, Datta S, Segal S. Is combined spinal-epidural analgesia associated with more rapid cervical dilation in nulliparous patients when compared with conventional epidural analgesia? Anesthesiology. 1999 Oct;91(4):920-5. doi: 10.1097/00000542-199910000-00010.

  PMID: 10519493 BACKGROUND

• Shnider SM, Abboud TK, Artal R, Henriksen EH, Stefani SJ, Levinson G. Maternal catecholamines decrease during labor after lumbar epidural anesthesia. Am J Obstet Gynecol. 1983 Sep 1;147(1):13-5. doi: 10.1016/0002-9378(83)90076-5.

  PMID: 6614080 BACKGROUND

• Clarke VT, Smiley RM, Finster M. Uterine hyperactivity after intrathecal injection of fentanyl for analgesia during labor: a cause of fetal bradycardia? Anesthesiology. 1994 Oct;81(4):1083. doi: 10.1097/00000542-199410000-00041. No abstract available.

  PMID: 7943823 BACKGROUND

• Cohen SE, Cherry CM, Holbrook RH Jr, el-Sayed YY, Gibson RN, Jaffe RA. Intrathecal sufentanil for labor analgesia--sensory changes, side effects, and fetal heart rate changes. Anesth Analg. 1993 Dec;77(6):1155-60. doi: 10.1213/00000539-199312000-00013.

  PMID: 8250307 BACKGROUND

• Van de Velde M. Neuraxial analgesia and fetal bradycardia. Curr Opin Anaesthesiol. 2005 Jun;18(3):253-6. doi: 10.1097/01.aco.0000169230.53067.49.

  PMID: 16534346 BACKGROUND

• Van de Velde M, Teunkens A, Hanssens M, Vandermeersch E, Verhaeghe J. Intrathecal sufentanil and fetal heart rate abnormalities: a double-blind, double placebo-controlled trial comparing two forms of combined spinal epidural analgesia with epidural analgesia in labor. Anesth Analg. 2004 Apr;98(4):1153-1159. doi: 10.1213/01.ANE.0000101980.34587.66.

  PMID: 15041616 BACKGROUND

• Abrao KC, Francisco RPV, Miyadahira S, Cicarelli DD, Zugaib M. Elevation of uterine basal tone and fetal heart rate abnormalities after labor analgesia: a randomized controlled trial. Obstet Gynecol. 2009 Jan;113(1):41-47. doi: 10.1097/AOG.0b013e31818f5eb6.

  PMID: 19104358 BACKGROUND

• Lopez-Zeno JA, Peaceman AM, Adashek JA, Socol ML. A controlled trial of a program for the active management of labor. N Engl J Med. 1992 Feb 13;326(7):450-4. doi: 10.1056/NEJM199202133260705.

  PMID: 1732771 BACKGROUND

• Frigoletto FD Jr, Lieberman E, Lang JM, Cohen A, Barss V, Ringer S, Datta S. A clinical trial of active management of labor. N Engl J Med. 1995 Sep 21;333(12):745-50. doi: 10.1056/NEJM199509213331201.

  PMID: 7643880 BACKGROUND

• Breen TW, Shapiro T, Glass B, Foster-Payne D, Oriol NE. Epidural anesthesia for labor in an ambulatory patient. Anesth Analg. 1993 Nov;77(5):919-24. doi: 10.1213/00000539-199311000-00008.

  PMID: 8214727 BACKGROUND

• Macones GA, Hankins GD, Spong CY, Hauth J, Moore T. The 2008 National Institute of Child Health and Human Development workshop report on electronic fetal monitoring: update on definitions, interpretation, and research guidelines. Obstet Gynecol. 2008 Sep;112(3):661-6. doi: 10.1097/AOG.0b013e3181841395.

  PMID: 18757666 BACKGROUND

• Anim-Somuah M, Smyth R, Howell C. Epidural versus non-epidural or no analgesia in labour. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD000331. doi: 10.1002/14651858.CD000331.pub2.

  PMID: 16235275 BACKGROUND

• Simmons SW, Cyna AM, Dennis AT, Hughes D. Combined spinal-epidural versus epidural analgesia in labour. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003401. doi: 10.1002/14651858.CD003401.pub2.

  PMID: 17636721 BACKGROUND

• Landau R, Carvalho B, Wong C, Smiley R, Tsen L, Van de Velde M. Elevation of uterine basal tone and fetal heart rate abnormalities after labor analgesia: a randomized controlled trial. Obstet Gynecol. 2009 Jun;113(6):1374. doi: 10.1097/AOG.0b013e3181a8909d. No abstract available.

  PMID: 19461449 BACKGROUND

• Halpern S, Leighton B: Epidural analgesia and the progress of labor, Evidence-based obstetric anesthesia. Edited by Halpern S, Douglas M. Oxford, Blackwell, 2005, pp10-22

  BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Cambic, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Anesthesiology

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 13, 2013
• Study Start: July 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

US (1)