Hydromorphone and C-section

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01598545

Enrollment

Registered

2012-05-15

Start date

2013-02-28

Completion date

2014-09-30

Last updated

2014-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

DRUGHydromorphone

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy women undergoing cesarean section

Exclusion criteria

* Any comorbidities other than obesity, hypertension, fetal anomalies

Design outcomes

Primary

Measure	Time frame	Description
Pain Scores, Visual Analogue Pain Scale	12 hours after intrathecal injection	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

Secondary

Measure	Time frame	Description
Pain Scores, Visual Analogue Pain Scale	Baseline	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

Countries

United States

Participant flow

Recruitment details

Subjects enrolled from January 2013 to June 2014 at Grady Memorial Hospital.

Participants by arm

Arm	Count
Hydromorphone Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief. ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg.	20
Total	20

Baseline characteristics

Characteristic	Hydromorphone
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	20 Participants
Region of Enrollment United States	20 participants
Sex: Female, Male Female	20 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 20
serious Total, serious adverse events	0 / 20