NCT02067520

Brief Summary

Introduction: Cesarean section (C/S) is usually performed under spinal with preservative free morphine for pain relief, but the investigators have a severe shortage of this formulation of morphine. Hydromorphone is a narcotic which acts peripherally and centrally to decrease pain. It has been used in spinals for postoperative pain relief and in pain pumps for relief of chronic pain. No randomized controlled studies have evaluated intrathecal (IT) hydromorphone for post C/S pain. Methods: This is a randomized double-blind controlled trial utilizing the up-down sequential allocation method1,2 to find the best dose of IT hydromorphone that provides pain relief following C/S. Patients will be given a morphine PCA pump for additional pain relief. Our first patient will receive 200 mcg of IT hydromorphone. Pain, nausea, and itching will be evaluated at 4, 8, 12 and 24 hours following the C/S via numeric rating scales; vomiting and morphine use per hour will be recorded. Success will be a median morphine usage of less than or equal to 1mg/hour in the following 16 hours. If a success, the next patient will be given 10 mcg less IT hydromorphone; if a failure, she will receive 10 mcg more. The study will end after 5 successes. Objective: The primary objective is to find the optimal dose of IT hydromorphone for pain relief following C/S. The secondary objectives are to define the incidence and severity of hydromorphone's side effects and determine the duration of analgesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

January 30, 2014

Last Update Submit

January 6, 2016

Conditions

Pain

Keywords

Post C/S pain relief

Outcome Measures

Primary Outcomes (1)

  • The primary objective is to find the optimal dose of IT hydromorphone for pain relief following C/S.

    At 24 hours following the C/S, the patient will rate her pain, degree of nausea, and itching with verbal numeric rating scales.PCA will also be queried for morphine usage.

Secondary Outcomes (2)

  • A secondary objective is to define the incidence and severity of hydromorphone's side effects.

    At 4, 8, 12 and 24 hours following the C/S, the patient will rate her degree of nausea, and itching with verbal numeric rating scales.

  • A secondary objective is to determine the duration of analgesia

    At 24 hours following the C/S, the PCA will be queried for morphine usage.

Study Arms (1)

IT hydromorphone dose

OTHER

dose response study

Drug: intrathecal hydromorphone (IT hydromorphone)

Interventions

intrathecal hydromorphone (IT hydromorphone)DRUG
IT hydromorphone dose

Eligibility Criteria

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

You may not qualify if:

  • Patient refusal,
  • Age less than 18 years
  • Onset of labor
  • Current opioid abuse
  • Use of methadone maintenance for previous opioid abuse
  • Allergy to hydromorphone
  • Contraindication to spinal anesthesia
  • Inability to obtain a spinal anesthetic
  • Language other than English or if unable to understand use of a PCA pump will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 1. Dixon WJ, Massey FJ. Introduction to statistical analysis. 4th ed. New York: McGraw-Hill, 1983; 377-441. 2. Dixon WJ. Staircase bioassay: the up-and-down method. Neurosci Biobehav Rev 1991;15:47-50. 3. AANA J. 2012 Aug;80(4 Suppl):S25-32. 4. AANA J. 2011 Oct;79(5):427-32. 5. Abram SE, Mampilly GA, Milosavljevic D. Anesthesiology 1997;87:127-134. 6. Drakeford MK, Pettine KA, Brookshire L, Ebert F. J Bone Joint Surg Am. 1991;73:424-428. 7. Rathmell JP, Lair TR, Nauman B. Anesth Analg 2005;101(suppl 5):30-43. 8. Sinatra RS, deLeon-Casasola OA, Ginsberg B, Viscusi ER, editors. Acute Pain Management, chapter 16, pp232. 9. Gautier P, Vandepitte C, Ramquet C., et al. Anesth Analg 2011;113:951-55. 10. O'Donnell DB, Iohom G. Anesthesiology 2009;111:25-9. 11. Vandepitte C, Gautier P, Xu D, et al. Anesthesiology 2013;118:863-7

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • H.Jane Huffnagle, DO

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 20, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

US(1)