Hydromorphone and C-section

Postoperative Pain Clinical Trial

Official title:

Determination of the ED50 of Intrathecal Hydromorphone for Post-cesarean Section Pain Relief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598545
• Other study ID #: IRB00058097
• Status: Completed
• Phase: Phase 2
• First received: May 10, 2012
• Last updated: December 9, 2014
• Start date: February 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Emory IRBUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy women undergoing cesarean section

Exclusion Criteria:

• Any comorbidities other than obesity, hypertension, fetal anomalies

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores, Visual Analogue Pain Scale	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).	12 hours after intrathecal injection	No
Secondary	Pain Scores, Visual Analogue Pain Scale	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).	Baseline	No
Secondary	Pain Scores, Visual Analogue Pain Scale	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).	6 hours after intrathecal injection	No
Secondary	Pain Scores, Visual Analogue Pain Scale	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).	18 hours after intrathecal injection	No
Secondary	Pain Scores, Visual Analogue Pain Scale	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).	24 hours after intrathecal injection	No