Postoperative Pain Clinical Trial
Official title:
A Prospective, Randomized, Control Trial of Ketorolac Versus Placebo on Opioid Analgesic Use, Estimated Blood Loss and Complications Following Cesarean Delivery With Epidural Morphine
NCT number | NCT02509312 |
Other study ID # | Ketorolac-1 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | October 2017 |
Verified date | May 2022 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this randomized, double-blind control trial to evaluate the effect of ketorolac given at the time of cord clamp has on estimated blood loss and postcesarean pain control. Patients will be randomized to either placebo or ketorolac prior to surgery. Those randomized to ketorolac will receive ketorolac at cord clamp and three additional doses every 6 hours (total 4 doses/24 hours). Those in the placebo group will receive normal saline during those time periods. Our primary outcome is to assess whether intra-operative ketorolac increases the estimated blood loss during Cesarean delivery.
Status | Completed |
Enrollment | 70 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Patients undergoing a scheduled or non-scheduled, non-urgent primary or repeat Cesarean delivery between 37-42 weeks gestational age, - Viable singleton intra-uterine pregnancy, - Patients undergoing a scheduled or unscheduled, non-emergent/non-urgent Cesarean delivery for placenta previa or vasa previa, - Neuraxial anesthesia with combined spinal-epidural placed for surgery, - Patients must be 18 years or older as well as willing and able to provide informed consent. Exclusion Criteria: - Patients unable or unwilling to provide informed consent, - Urgent or emergent Cesarean delivery - Multiple fetal gestations (>1 intrauterine pregnancy), - Cesarean delivery for bleeding such as placental abruption or actively bleeding placenta previa or vasa previa, - Contraindication to NSAID use eg: allergy, chronic renal disease, - Patients with acute or chronic platelet dysfunction (e.g.: idiopathic thrombocytopenic purpura, HELLP syndrome), - Platelets <100k, - History of peptic ulcer disease, - Inherited or acquired coagulopathies or bleeding disorder, (disseminated intravascular coagulopathy, hemophilia), - Suspected or proven placenta accreta, increta or percreta, - Inability to receive epidural morphine, - Diagnosed chronic pain disorder on chronic adjunct or opioid analgesia, - Use of general anesthesia during procedure. Intraoperative exclusion criteria: - EBL > 1000 ml prior to cord clamp |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Case Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center |
United States,
Blackburn A, Stevens JD, Wheatley RG, Madej TH, Hunter D. Balanced analgesia with intravenous ketorolac and patient-controlled morphine following lower abdominal surgery. J Clin Anesth. 1995 Mar;7(2):103-8. — View Citation
Diemunsch P, Alt M, Diemunsch AM, Treisser A. Post cesarean analgesia with ketorolac tromethamine and uterine atonia. Eur J Obstet Gynecol Reprod Biol. 1997 Apr;72(2):205-6. — View Citation
El-Tahan MR, Warda OM, Yasseen AM, Attallah MM, Matter MK. A randomized study of the effects of preoperative ketorolac on general anaesthesia for caesarean section. Int J Obstet Anesth. 2007 Jul;16(3):214-20. Epub 2007 Apr 24. — View Citation
Elhakim M, Fathy A, Amine H, Saeed A, Mekawy M. Effect of i.v. tenoxicam during caesarean delivery on platelet activity. Acta Anaesthesiol Scand. 2000 May;44(5):555-9. — View Citation
Gobble RM, Hoang HLT, Kachniarz B, Orgill DP. Ketorolac does not increase perioperative bleeding: a meta-analysis of randomized controlled trials. Plast Reconstr Surg. 2014 Mar;133(3):741-755. doi: 10.1097/01.prs.0000438459.60474.b5. — View Citation
Lowder JL, Shackelford DP, Holbert D, Beste TM. A randomized, controlled trial to compare ketorolac tromethamine versus placebo after cesarean section to reduce pain and narcotic usage. Am J Obstet Gynecol. 2003 Dec;189(6):1559-62; discussion 1562. — View Citation
Pavy TJ, Paech MJ, Evans SF. The effect of intravenous ketorolac on opioid requirement and pain after cesarean delivery. Anesth Analg. 2001 Apr;92(4):1010-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimated Blood Loss (EBL) | Estimation of blood loss during surgery | Immediately post-op | |
Secondary | Post-Partum Hemorrhage | Rate of Post-Partum Hemorrhage between groups during the first 24 hours pst-partum. | 0 - 24 hours post-partum | |
Secondary | Corrected Change in Hct on POD1. | Corrected change in Hct on POD1. Performed by subtracting POD1 Hct from POD0 Hct. Correction for transfusion by further subtracting 3 per unit of pRBC transfused to account for the typical change seen per unit transfused. | POD1 | |
Secondary | Uterotonic Doses | Total number of uterotonic doses including methylergonovine, carboprost and misoprostol. | 0 - 24 hours post-partum | |
Secondary | Units of Packed Reb Blood Cell Transfused | Total number of Units of Packed Reb Blood Cell Transfused in intra-op until 24 hours post-partum. | Intra-op until 24 hours post-partum. | |
Secondary | Hydromorphone Use | Use of any intravenous hydromorphone administered within the first 24 hours after cesarean delivery. | 0 - 24 hours post-partum | |
Secondary | Total Hydromorphone Dose | Total hydromorphone doses in mg in the first 24 hours post-partum. | 0 - 24 hours post-partum. | |
Secondary | Anti-emetic Doses | Total doses of medications to treat pruritus (opioid side-effect) including ondansetron and promethazine. | 0 - 24 hours post-partum | |
Secondary | Pruritus Doses | Total doses of medications to treat pruritus (opioid side-effect) including diphenhydramine, nalbuphine and naloxone. | 0 - 24 hours post-partum | |
Secondary | Percentile Change in Systolic Blood Pressure at 6,12, and 24 Hours | Percentile change in Systolic Blood Pressure at 6,12, and 24 hours for each patient's baseline defined by immediate post-op PACU vitals. | 0 - 24 hours post-partum | |
Secondary | Percentile Change in Diastolic Blood Pressure (DBP) at 6,12, and 24 Hours | Percentile change in diastolic Blood Pressure at 6,12, and 24 hours for each patient's baseline defined by immediate post-op PACU vitals. | 0 - 24 hours post-partum | |
Secondary | Change in Pain Score Post-Cesarean Delivery | Pain score post-Cesarean Delivery using 11-point numerical rating scale (NRS): 0-10 where 0 is no pain and 10 is the worst pain imaginable | Up to 24 hours post-cesarean delivery |
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