Hydromorphone and C-section

NCT01598545 | Completed Phase 2 Results DMC

• 1 other identifier: IRB00058097
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the dose of hydromorphone which will relieve the pain of women following a cesarean section when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 3 out of 10 12 hours after intrathecal injection in 50% of women. Secondary objectives include determining the average amount of time patients obtain pain relief after injection. Other secondary objectives include determining the frequency and severity of side-effects associated with intrathecal administration of hydromorphone, including: bradycardia, hypotension, respiratory depression, apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and delivery for planned cesarean section desiring will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone. After the intrathecal injection is given, patients will undergo their cesarean section. The patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire. The patient's medical record will be reviewed to determine when she first requested supplemental pain medication. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be assessed.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pain Scores, Visual Analogue Pain Scale

  Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

  12 hours after intrathecal injection

Secondary Outcomes (4)

• Pain Scores, Visual Analogue Pain Scale

  Baseline

• Pain Scores, Visual Analogue Pain Scale

  6 hours after intrathecal injection

• Pain Scores, Visual Analogue Pain Scale

  18 hours after intrathecal injection

• Pain Scores, Visual Analogue Pain Scale

  24 hours after intrathecal injection

Study Arms (1)

Hydromorphone

EXPERIMENTAL

Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally

Drug: Hydromorphone

Interventions

Hydromorphone DRUG

Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.

Hydromorphone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women undergoing cesarean section

You may not qualify if:

• Any comorbidities other than obesity, hypertension, fetal anomalies

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; 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. Grant Lynde
• Organization: Emory University

glynde@emory.edu

404-778-3900

Study Officials

• Grant C Lynde, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 15, 2012
• Study Start: February 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 17, 2014
• Results First Posted: December 17, 2014

Record last verified: 2014-12

Locations

US (1)