Intrathecal Hydromorphone for Labor Analgesia
Overview
- Phase
- Not Applicable
- Intervention
- Hyperbaric bupivacaine
- Conditions
- Pregnancy
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Effect on maternal temperature during labor
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
The objective of this study is to evaluate the effect of intrathecal hydromorphone on the duration of labor analgesia and the incidence of epidural-associated temperature increase in laboring parturients. We hypothesize that intrathecal administration of longer-acting hydromorphone will:
- Prolong the duration and improve the quality of analgesia in labor, and
- Decrease the incidence of epidural-associated temperature increase in labor.
Investigators
Dominique Arce
Instructor of Anaesthesia
Brigham and Women's Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients are eligible for enrollment if they are healthy, pregnant females between the ages of 18 and 45 years, primiparous, and at term gestation (≥ 37 weeks).
Exclusion Criteria
- •Patients with a Category II or III fetal heart rate tracing, a fetus with intrauterine growth restriction, prolonged rupture of membranes, recent diagnosis of infection of any cause, or in whom dural puncture is contraindicated will be excluded from the study.
Arms & Interventions
No Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 0.05 ml of 0.9% normal saline.
Intervention: Hyperbaric bupivacaine
No Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 0.05 ml of 0.9% normal saline.
Intervention: Fentanyl
Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)
Intervention: Hydromorphone
Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)
Intervention: Hyperbaric bupivacaine
Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)
Intervention: Fentanyl
Outcomes
Primary Outcomes
Effect on maternal temperature during labor
Time Frame: 2 years
The primary outcome measure will be the incidence of maternal temperature increase, defined as an increase in maternal temperature by 1 degree celsius over the baseline temperature recorded prior to the onset of epidural analgesia.
Secondary Outcomes
- Effect on efficacy of labor analgesia(2 years)