- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01982851
Effects of Analgesic Techniques on Duration of Labor for Induction Patients
A Randomized Trial of the Impact of Three Labor Analgesia Techniques on Labor Duration in Nulliparous Labor Inductions
Study Overview
Status
Intervention / Treatment
Detailed Description
At the first request for neuraxial labor analgesia, the cervix will be examined. If < 4.0 cm, the patient will be randomized to either Combined spinal epidural (CSE) technique with intrathecal fentanyl, CSE technique with intrathecal bupivacaine and fentanyl, or epidural de novo technique.
Labor analgesia will be administered in the sitting position, at either the L2-3 or L3-4 interspace. All patients will receive a 500mL intravenous bolus of Lactated Ringer's solution. The epidural space will be located using the loss-of-resistance technique utilizing a 17-G Tuohy epidural needle. Patients assigned to an intrathecal dose will utilize the standard needle-through-needle technique. A 19-G epidural catheter will be inserted 5 cm in the epidural space and maintenance epidural analgesia will be initiated. Patients assigned to an epidural de novo technique will have the epidural space identified with a similar loss-of-resistance technique. 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.
Maintenance epidural analgesia will consist of patient-controlled epidural analgesia (PCEA) with bupivacaine 0.0625% and fentanyl 1.95 mcg/mL at the following parameters: basal rate of 8 mL/hr with bolus dose = 8 mL, lock-out interval = 10 min and maximum volume = 32 mL/hr.
Breakthrough pain in all groups will be managed using anesthesiologist administered epidural boluses of bupivacaine 1.25 mg/mL, 10-15mL, without fentanyl. If instrumental vaginal delivery is required, patients will receive anesthesiologist administered epidural boluses of chloroprocaine 30 mg/mL, 5-10 mL. If a patient does not have an adequate level of analgesia or has a one-sided block, despite epidural redoses, the epidural catheter will be replaced at another level and 0.125% bupivacaine 5-15 mL will be administered until an adequate level of analgesia is established.
The primary outcome of the study is duration of first stage of labor. Regular cervical examinations are necessary. Typically, full cervical dilation is diagnosed with a cervical examination only when the patient complains of rectal pressure, which is likely to be at a later time period in women with effective neuraxial analgesia compared to women with systemic opioid analgesia. Therefore, the duration of the first stage of labor will be artificially prolonged if regular cervical exams are not performed. The investigators intend to perform sterile cervical examinations at the first request for labor analgesia, then at routine times during the course of labor per the managing OB provider's discretion, and then every 2 hours after the patient reaches 90-100% cervical effacement until complete cervical dilation.
Fetal heart rate (FHR) tracings without information about group assignment or other treatment modalities will also be assessed by a perinatologist.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nulliparous
- American Society of Anesthesia Physical Status (ASA) 2 females
- > 18 years old
- term (>37 weeks gestation)
- singleton
- vertex pregnancies
- scheduled induction of labor
Exclusion Criteria:
- Non-vertex presentation
- Spontaneous labor or spontaneous rupture of membranes
- contraindication to opioid or neuraxial analgesia
- contraindication to combine spinal-epidural technique (e.g. unfavorable airway exam)
- cervical dilation > 4.0cm
- administration of systemic hydromorphine within 4 hours of epidural request
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group E
Epidural de novo technique
|
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.
|
Active Comparator: Group BF
Combined spinal epidural (CSE) technique with intrathecal 0.5% Bupivicaine 2.5mg + Fentanyl 15mcg
|
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.
|
Active Comparator: Group F
Combined spinal epidural (CSE) technique with intrathecal fentanyl 25mcg
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of first stage of labor
Time Frame: Onset of contractions or rupture of membrances to cervical dilation of 10cm
|
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 rupture of membrances to cervical dilation of 10cm
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence or absence of fetal heart rate decelerations
Time Frame: Time of first analgesic dose to 60 minutes
|
Time of first analgesic dose to 60 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher Cambic, MD, Northwestern University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: N Engl J Med 1995 Oct 26;333(17):1163.
- 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.
- 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.
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STU00031120
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