Intrathecal Hydromorphone for Labor Analgesia

NCT ID: NCT01598506

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-02-28

Brief Summary

This study will investigate the dose of hydromorphone which will relieve the pain of women in labor 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 4 out of 10 thirty minutes after intrathecal injection in 50% of women. Secondary objectives include determining this dose at five and ten minutes after injection. Thirty women admitted to labor and delivery for planned vaginal delivery desiring epidural placement 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 and the epidural is placed, visual analogue pain scores will be assessed 60 minutes following injection. 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, fetal heart rate, and any side effects will also be assessed.

Conditions

Labor Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hydromorphone

Laboring patients receive ED50 of hydromorphone one time intrathecally

Group Type: EXPERIMENTAL

Hydromorphone

Intervention Type: DRUG

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

Interventions

Hydromorphone

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy patients
• Labor
• Desires pain relief

Exclusion Criteria

• Any comorbidities other than obesity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Grant Lynde

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grant C Lynde, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Countries

United States

References

O'Reilly-Shah V, Lynde GC. Determination of ED50 and time to effectiveness for intrathecal hydromorphone in laboring patients using Dixon's up-and-down sequential allocation method. BMC Anesthesiol. 2018 Oct 5;18(1):140. doi: 10.1186/s12871-018-0603-8.

Reference Type: DERIVED

PMID: 30290794 (View on PubMed)

Other Identifiers

IRB00054701

Identifier Type: -

Identifier Source: org_study_id