Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose

NCT02009722 | Completed Phase 4 Results DMC

• 1 other identifier: 13-008490
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve pain control after cesarean delivery. In this study, the investigators are going to determine the doses of each of those medicines that provides optimal pain control to women undergoing cesarean delivery while limiting side effects related to those medicines. The investigators hypothesize that the doses of hydromorphone and morphine that provide optimal pain control without significant side effects will be 100 micrograms and 150 micrograms, respectively. The investigators further hypothesize that at each respective optimal dose, side effects will be less in the hydromorphone group.

Conditions

Analgesia, Obstetrical; Cesarean Section

Keywords

Cesarean Delivery; Intrathecal Morphine; Intrathecal Hydromorphone; Obstetrical Analgesia; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• Dose of IT Morphine and IT Hydromorphone for Adequate Analgesia (Pain Score Less Than or Equal to 3) in 90% of Patients

  Each patient will be interviewed by a member of the study team 12 hours after receiving their spinal anesthetic (which will include either hydromorphone or morphine). Patients will be asked to rate their current level of pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A pain score \<4 will be considered a success. The up-down sequential allocation method will be used to determine the dose (mcg) of IT hydromorphone and IT morphine for subsequent patients

  12 hours after administration of spinal anesthesia

Secondary Outcomes (9)

• Side Effects: Pruritus

  6 hours after spinal administration

• Side Effects: Nausea

  6 hours after spinal

• Side Effects: Sedation

  6, 12, and 24 hours after spinal administration

• Pruritus

  12 hours after spinal

• Pruritus

  24 hours after spinal

Study Arms (2)

Intrathecal hydromorphone

ACTIVE COMPARATOR

Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.

Drug: Hydromorphone

Intrathecal morphine

ACTIVE COMPARATOR

Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.

Drug: Morphine

Interventions

Morphine DRUG

Duramorph is administered as part of spinal anesthesia for post-operative pain relief.

Also known as: Duramorph

Intrathecal morphine

Hydromorphone DRUG

Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control

Also known as: Dilaudid

Intrathecal hydromorphone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women presenting for elective cesarean delivery with no major co-morbidities, including pregnancy induced co-morbidities (e.g. pre-eclampsia)
• Singleton gestation at term (37-42 weeks)
• Desire to have a spinal anesthesia technique for cesarean delivery

You may not qualify if:

• Current or historical evidence of clinically significant medical disease or condition
• Any contraindication to the administration of a spinal technique for anesthesia
• History of hypersensitivity or idiosyncratic reaction to opioid medications
• Chronic pain syndrome or current regular opioid use
• Evidence of anticipated fetal anomalies
• Allergy or intolerance to Tylenol, ketorolac, ibuprofen, or oxycodone
• BMI \> 40

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Rochester Methodist Hospital, Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (9)

• Beatty NC, Arendt KW, Niesen AD, Wittwer ED, Jacob AK. Analgesia after Cesarean delivery: a retrospective comparison of intrathecal hydromorphone and morphine. J Clin Anesth. 2013 Aug;25(5):379-383. doi: 10.1016/j.jclinane.2013.01.014. Epub 2013 Aug 17.

  PMID: 23965210 BACKGROUND

• Palmer CM, Emerson S, Volgoropolous D, Alves D. Dose-response relationship of intrathecal morphine for postcesarean analgesia. Anesthesiology. 1999 Feb;90(2):437-44. doi: 10.1097/00000542-199902000-00018.

  PMID: 9952150 BACKGROUND

• Rauch E. Intrathecal hydromorphone for postoperative analgesia after cesarean delivery: a retrospective study. AANA J. 2012 Aug;80(4 Suppl):S25-32.

  PMID: 23248827 BACKGROUND

• Rauch E. Intrathecal hydromorphone for cesarean delivery: in search of improved postoperative pain management: a case report. AANA J. 2011 Oct;79(5):427-32.

  PMID: 23256273 BACKGROUND

• Terajima K, Onodera H, Kobayashi M, Yamanaka H, Ohno T, Konuma S, Ogawa R. Efficacy of intrathecal morphine for analgesia following elective cesarean section: comparison with previous delivery. J Nippon Med Sch. 2003 Aug;70(4):327-33. doi: 10.1272/jnms.70.327.

  PMID: 12928713 BACKGROUND

• Gehling M, Tryba M. Risks and side-effects of intrathecal morphine combined with spinal anaesthesia: a meta-analysis. Anaesthesia. 2009 Jun;64(6):643-51. doi: 10.1111/j.1365-2044.2008.05817.x.

  PMID: 19462494 BACKGROUND

• Dougherty TB, Baysinger CL, Henenberger JC, Gooding DJ. Epidural hydromorphone with and without epinephrine for post-operative analgesia after cesarean delivery. Anesth Analg. 1989 Mar;68(3):318-22.

  PMID: 2465709 BACKGROUND

• Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a precis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 Jul;107(1):144-52. doi: 10.1097/01.anes.0000267514.42592.2a.

  PMID: 17585226 BACKGROUND

• Gerancher JC, Floyd H, Eisenach J. Determination of an effective dose of intrathecal morphine for pain relief after cesarean delivery. Anesth Analg. 1999 Feb;88(2):346-51. doi: 10.1097/00000539-199902000-00023.

  PMID: 9972754 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Morphine; Hydromorphone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Hans Sviggum
• Organization: Mayo Clinic

sviggum.hans@mayo.edu

507-581-6083

Study Officials

• Hans P Sviggum, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: July 25, 2016
• Results First Posted: May 20, 2016

Record last verified: 2016-06

Locations

US (1)