Clinical Trials Logo

Clinical Trial Summary

In the United States the incidence of cesarean deliveries have increased over the last several decades and is currently approximately 30% nationwide. The anesthesia and analgesia for elective c-sections vary between institutions.

Parturients present a unique challenge for the anesthesiologist as the mother has to care not only for herself, but also for the newborn postpartum. While intrathecal opioids provide adequate pain relief, they do so at the cost of bothersome side effects for patients, such as pruritus and nausea/vomiting.

Intrathecal hydromorphone has started to be explored as a new option for intrathecal analgesia. A study done by Beatty et al. showed in a retrospective review that 40 mcg of intrathecal dilaudid was safe and effective as compared to intrathecal morphine for analgesia after cesarean delivery. Additionally they showed no difference in side effect profiles of the two medications. Mhyre et al. investigated the use of 100 mcg of intrathecal dilaudid with hyperbaric bupivacaine in varying dosages for labor analgesia. The results were inconclusive, but the dosage of hydromorphone was reported to be without adverse effects.

Virginia Commonwealth University Health Systems has successfully instituted the use of intrathecal morphine with superior analgesia but with undesired side effects, most notably pruritus. Recent drug shortages of duramorph have prompted investigators to seek alternative options for post cesarean section analgesia. The investigators are interested in determining the dose, efficacy, and side effect profile of intrathecal hydromorphone. Although our institution has never utilized intrathecal hydromorphone for our patient population, it has been studied at various other institutions where it has been found to be safe and efficacious with an acceptable side effect profile.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02787928
Study type Interventional
Source Virginia Commonwealth University
Contact
Status Terminated
Phase Phase 1
Start date April 2016
Completion date December 31, 2017

See also
  Status Clinical Trial Phase
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03631329 - Predictability of Preoperative Carotid Artery Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Completed NCT03244540 - Regional Analgesia After Cesarean Section Phase 4
Active, not recruiting NCT03760718 - Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery Early Phase 1
Active, not recruiting NCT04965779 - The Effect of Abdominal Binder Use on Postpartum Pain, Bleeding, and Breastfeeding Success in Cesarean Delivery Women N/A
Terminated NCT01687972 - INSORB Versus Subcuticular Sutures at Cesarean Section Phase 1
Withdrawn NCT01211431 - Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine Phase 4
Completed NCT00991627 - Different Approaches to Maternal Hypotension During Cesarean Section Phase 4
Completed NCT00987701 - Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors N/A
Completed NCT01049477 - The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery N/A
Terminated NCT00524511 - Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples N/A
Terminated NCT00386477 - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial N/A
Completed NCT00375986 - A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section N/A
Completed NCT00517140 - Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function N/A
Terminated NCT05051150 - Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section Phase 4
Terminated NCT03695172 - Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section Phase 4
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Completed NCT06012747 - Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Not yet recruiting NCT05187520 - Naldebain for Control of Post-Cesarean Section Pain Phase 2
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A