DPE Technique in Labor Epidural for Morbidly Obese Women

NCT03074695 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00079368
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine differences in block quality between the "dural-puncture epidural" (DPE) and standard epidural (EPL) techniques for labor analgesia in the morbidly obese patient. The investigators hypothesize that when compared to the standard EPL, the DPE technique will improve block quality . Study participants will be randomized by computer-generated sequence to EPL or DPE arms, stratified by class of obesity (BMI 35-39.9 kg/m2, 40\< 50 kg/m2 and ≥ 50 kg/m2) and by parity (nulliparous versus multiparous). All patients will receive a neuraxial technique in the sitting position at L3/4 or L4/5 using loss of resistance to saline. In the DPE group, a 25-g Whitacre needle will be used to puncture the dura. In both groups, the epidural catheter will be threaded 5 cm in the epidural space with an initiation dose of 15 ml of ropivacaine 0.1% with fentanyl (2 mcg/ml) over 6 minutes as per standard practice. After the initial loading dose and epidural pump is started, the blinded investigator will enter the patient's room to start data collection (time 0). Data will be collected for the first 30 minutes of epidural placement at 3,6,9,12,15,18 21, and 30 minutes to detect the time to achieve target pain ≤ 1/10, then assessed at standardized times (ever 2 hour) until delivery. Breakthrough pain will be managed by a standardized protocol. Other data to be collected will include: catheter adjustments and replacements, physician top-ups, asymmetrical block, pain score, motor block, sensory level to ice, hypotension, total anesthetic dose required, and PCEA use. The primary outcome of this study is block quality defined by a composite of five components: (1) asymmetric block after 30 minutes of initiation, (2) top-up interventions, (3) catheter adjustments (4) failed catheter requiring replacement, and (5) failed epidural requiring general anesthesia or replacement neuraxial anesthesia for emergency cesarean section. Secondary outcomes include time to numeric pain rating scale ≤1, maternal adverse events (hypotension, fetal bradycardia, PDPH), motor block, duration of second stage of labor, total labor epidural time, total anesthetic dose required, PCEA use, and mode of delivery. There is no increased risk/safety issue with placing a dural puncture technique than with epidural for labor analgesia.

Conditions

Morbid Obesity; Labor Pain

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Required Asymmetric Block, Top-up Interventions, Catheter Adjustments, Replacement of Epidural Catheter, or Failure of Block Requiring Emergency General Anesthesia or Rescue Neuraxial Prior to Cesarean Delivery

  Composite outcome: asymmetric block, top-up interventions required, catheter adjustments, replacement of epidural catheter, or failure or block requiring emergency general anesthesia or rescue neuraxial prior to cesarean delivery Values shared are indicative of the number of participants who have the one or more of the composite elements for the composite outcome.

  From time of randomization to time of delivery, assessed at standardized times (ever 2 hour) until delivery (estimated 72 hours).

Secondary Outcomes (8)

• Time to Pain Relief

  Data will be collected for the first 30 minutes of epidural placement to achieve target pain ≤ 1/10

• Degree of Motor Block as Measured by the Lowest Bromage Score

  From time of randomization to time of baby delivery (estimated 72 hours)

• Number of Participants With Maternal Adverse Events

  From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)

• Duration of Second Stage of Labor

  From time of randomization to time of baby delivery (estimated 72 hours)

• Total Labor Epidural Time

  Total anesthetic time from time of epidural placement until discontinuation (estimated 72 hours)

Other Outcomes (1)

• Satisfaction in Anesthetic Care - Likert Scale

  Postpartum day 1

Study Arms (2)

Dural Puncture Epidural (DPE)

EXPERIMENTAL

Women who have analgesia initiated with a DPE technique

Procedure: Dural puncture epidural (DPE); Drug: Dural puncture epidural (DPE)

Standard Epidural (EPL)

EXPERIMENTAL

Women who have analgesia initiated with an epidural technique

Procedure: Standard Epidural (EPL); Drug: Standard Epidural (EPL)

Interventions

Dural puncture epidural (DPE) PROCEDURE

Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing

Dural Puncture Epidural (DPE)

Standard Epidural (EPL) PROCEDURE

Standard epidural placement

Standard Epidural (EPL)

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women admitted to the Duke Birthing Center for spontaneous or induced vaginal delivery will be screened. After usual consultation with the anesthesia team is completed and consent for anesthesia services are obtained, eligible patients will be approached to by a member of the study team.
• ages 18-45
• singleton
• vertex fetuses at 37-41 weeks' gestation
• nulliparous and multiparous women
• cervical dilation of 2-7cm
• BMI ≥ 35 kg/m2,
• pain score \> 4
• English-speaking ability.

You may not qualify if:

• chronic opioid use
• Major cardiac disease
• contraindications to regional anesthesia

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

Related Publications (11)

• Vricella LK, Louis JM, Mercer BM, Bolden N. Impact of morbid obesity on epidural anesthesia complications in labor. Am J Obstet Gynecol. 2011 Oct;205(4):370.e1-6. doi: 10.1016/j.ajog.2011.06.085. Epub 2011 Jun 29.

  PMID: 21864821 BACKGROUND

• Hood DD, Dewan DM. Anesthetic and obstetric outcome in morbidly obese parturients. Anesthesiology. 1993 Dec;79(6):1210-8. doi: 10.1097/00000542-199312000-00011.

  PMID: 8267196 BACKGROUND

• Collis RE, Davies DW, Aveling W. Randomised comparison of combined spinal-epidural and standard epidural analgesia in labour. Lancet. 1995 Jun 3;345(8962):1413-6. doi: 10.1016/s0140-6736(95)92602-x.

  PMID: 7760614 BACKGROUND

• Cappiello E, O'Rourke N, Segal S, Tsen LC. A randomized trial of dural puncture epidural technique compared with the standard epidural technique for labor analgesia. Anesth Analg. 2008 Nov;107(5):1646-51. doi: 10.1213/ane.0b013e318184ec14.

  PMID: 18931227 BACKGROUND

• Suzuki N, Koganemaru M, Onizuka S, Takasaki M. Dural puncture with a 26-gauge spinal needle affects spread of epidural anesthesia. Anesth Analg. 1996 May;82(5):1040-2. doi: 10.1097/00000539-199605000-00028.

  PMID: 8610864 BACKGROUND

• Hess PE, Pratt SD, Lucas TP, Miller CG, Corbett T, Oriol N, Sarna MC. Predictors of breakthrough pain during labor epidural analgesia. Anesth Analg. 2001 Aug;93(2):414-8, 4th contents page. doi: 10.1097/00000539-200108000-00036.

  PMID: 11473872 BACKGROUND

• Eappen S, Blinn A, Segal S. Incidence of epidural catheter replacement in parturients: a retrospective chart review. Int J Obstet Anesth. 1998 Oct;7(4):220-5. doi: 10.1016/s0959-289x(98)80042-3.

  PMID: 15321183 BACKGROUND

• Pan PH, Bogard TD, Owen MD. Incidence and characteristics of failures in obstetric neuraxial analgesia and anesthesia: a retrospective analysis of 19,259 deliveries. Int J Obstet Anesth. 2004 Oct;13(4):227-33. doi: 10.1016/j.ijoa.2004.04.008.

  PMID: 15477051 BACKGROUND

• Roofthooft E. Anesthesia for the morbidly obese parturient. Curr Opin Anaesthesiol. 2009 Jun;22(3):341-6. doi: 10.1097/ACO.0b013e328329a5b8.

  PMID: 19412095 BACKGROUND

• Tien M, Allen TK, Mauritz A, Habib AS. A retrospective comparison of programmed intermittent epidural bolus with continuous epidural infusion for maintenance of labor analgesia. Curr Med Res Opin. 2016 Aug;32(8):1435-40. doi: 10.1080/03007995.2016.1181619. Epub 2016 May 20.

  PMID: 27100210 BACKGROUND

• Gunatilake RP, Smrtka MP, Harris B, Kraus DM, Small MJ, Grotegut CA, Brown HL. Predictors of failed trial of labor among women with an extremely obese body mass index. Am J Obstet Gynecol. 2013 Dec;209(6):562.e1-5. doi: 10.1016/j.ajog.2013.07.023. Epub 2013 Jul 24.

  PMID: 23891628 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Labor Pain

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Results Point of Contact

• Title: Ashraf Habib, M.D.
• Organization: Duke University

ashraf.habib@duke.edu

919-681-4544

Study Officials

• Ashraf Habib

  Duke University Hospital Systems

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 9, 2017
• Study Start: April 1, 2017
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: June 1, 2022
• Results First Posted: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)