NCT02789410

Brief Summary

Intrathecal (IT) opioids are commonly administered with local anesthetic during spinal anesthesia for post-Cesarean delivery analgesia. Traditionally, IT morphine has been used but the use of IT hydromorphone is growing. A previous study has shown that the effective dose for postoperative analgesia in 90% patients (ED90) for both IT hydromorphone and IT morphine (NCT02009722). These doses were found to be 75 mcg for hydromorphone and 150 mcg for morphine. The current proposed study would compare the duration of analgesia of IT morphine vs IT hydromorphone after elective cesarean delivery. Additionally, the investigators will compare each drug with respect the incidence of nausea and pruritus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 25, 2019

Completed
Last Updated

April 25, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

May 31, 2016

Results QC Date

March 29, 2019

Last Update Submit

April 24, 2019

Conditions

Analgesia, ObstetricalObstetric Surgical Procedures

Keywords

Cesarean deliveryAnalgesiaIntrathecal opioids

Outcome Measures

Primary Outcomes (1)

  • NRS Score for Pain (0-10) With Movement 24 Hours After Spinal Administration

    Each patient will be interviewed by a member of the study team 24 hours after receiving their spinal anesthetic. Patients will be asked to rate their current level of pain on a Numeric Rating Scale (NRS) of 0 (no pain) to 10 (worst pain imaginable).

    24 hours after administration of spinal anesthesia

Secondary Outcomes (2)

  • Nausea

    24 hours after administration of spinal anesthesia

  • Pruritus

    24 hours after administration of spinal anesthesia

Study Arms (2)

Intrathecal hydromorphone

ACTIVE COMPARATOR

Patients will be randomized to receive a one time dose of 75 mcg intrathecal hydromorphone as part of their spinal anesthesia.

Drug: Hydromorphone

Intrathecal morphine

ACTIVE COMPARATOR

Patients will be randomized to receive a one time dose of 150 mcg intrathecal morphine as part of their spinal anesthesia.

Drug: Morphine

Interventions

MorphineDRUG

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

Also known as: Duramorph
Intrathecal morphine
HydromorphoneDRUG

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

Also known as: Dilaudid
Intrathecal hydromorphone

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status II-III women presenting for elective cesarean delivery
  • Term gestation (37-42 weeks)
  • Desire to have a spinal anesthesia technique for cesarean delivery

You may not qualify if:

  • Any contraindication to the administration of a spinal technique for anesthesia
  • History of intolerance or adverse reaction to opioid medications
  • Chronic pain syndrome or current opioid use \>30 oral morphine equivalents/day
  • Allergy or intolerance to acetaminophen, ketorolac, ibuprofen, or oxycodone
  • Current BMI \> 50

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (9)

  • Bucklin BA, Hawkins JL, Anderson JR, Ullrich FA. Obstetric anesthesia workforce survey: twenty-year update. Anesthesiology. 2005 Sep;103(3):645-53. doi: 10.1097/00000542-200509000-00030. No abstract available.

    PMID: 16129992BACKGROUND

  • Sviggum HP, Arendt KW, Jacob AK, Niesen AD, Johnson RL, Schroeder DR, Tien M, Mantilla CB. Intrathecal Hydromorphone and Morphine for Postcesarean Delivery Analgesia: Determination of the ED90 Using a Sequential Allocation Biased-Coin Method. Anesth Analg. 2016 Sep;123(3):690-7. doi: 10.1213/ANE.0000000000001229.

    PMID: 26974022BACKGROUND

  • 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: 19462494BACKGROUND

  • 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: 9952150BACKGROUND

  • 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: 12928713BACKGROUND

  • 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: 23965210BACKGROUND

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

    PMID: 23248827BACKGROUND

  • 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: 23256273BACKGROUND

  • Nortcliffe SA, Shah J, Buggy DJ. Prevention of postoperative nausea and vomiting after spinal morphine for Caesarean section: comparison of cyclizine, dexamethasone and placebo. Br J Anaesth. 2003 May;90(5):665-70. doi: 10.1093/bja/aeg120.

    PMID: 12697596BACKGROUND

Related Links

MeSH Terms

Conditions

Agnosia

Interventions

MorphineHydromorphone

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Dr. Hans P. Sviggum
Organization
Mayo Clinic
sviggum.hans@mayo.edu
507-284-9697

Study Officials

  • Hans P Sviggum

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 3, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2017

Study Completion

March 15, 2018

Last Updated

April 25, 2019

Results First Posted

April 25, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)