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Phase 2 N=22 Single-blind Treatment

Intrathecal Hydromorphone for Labor Analgesia

Labor Pain

Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Pain Score, Visual Analogue Pain Scores — 1.9 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Hydromorphone (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Emory University
Primary completion
Feb 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Score, Visual Analogue Pain Scores
1.9
SECONDARY
Pain Scores, Visual Analogue Pain Scale
8.6

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.

Eligibility Criteria

Inclusion Criteria

  • Healthy patients
  • Labor
  • Desires pain relief

Exclusion Criteria

  • Any comorbidities other than obesity
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01598506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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