Postoperative Pain Clinical Trial
— KetoPltAggOfficial title:
Prospective Evaluation of the Effects of IV Ketorolac on Platelet Function Post-Cesarean Delivery
Verified date | May 2024 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption. The effect of NSAIDs on healthy volunteers results in inhibition of platelet aggregation and prolonged bleeding time. However, in the obstetric population, the presence and degree of platelet inhibition after NSAID exposure is less clear. The investigators plan to use Platelet Aggregometry and Thromboelastography (TEG) to evaluate the effect of ketorolac on platelets.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | August 30, 2024 |
Est. primary completion date | February 3, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Pregnant - Undergoing routine, scheduled cesarean section - Gestation >37 weeks - Singleton gestation - Intraoperative anesthesia - 1.5 ml of intrathecal bupivicaine 0.75%, 25mcg of intrathecal fentanyl and 250 mcg of intrathecal morphine via Spinal or Combined Spinal Epidural Exclusion Criteria: - Pre-eclampsia with severe features or HELLP - Allergy to NSAIDs - Pre-existing bleeding disorder - Other major risk factor for postpartum hemorrhage (placenta accreta, large uterine fibroid) - Chronic kidney disease - Plt count less than 100k - Gastric ulcer or gastric bleeding - Pre-existing uterine bleeding or disseminated intravascular coagulation - Patient or Obstetrician refusal - Intraoperative exclusion criteria - Postpartum hemorrhage (EBL >1000 ml) or unplanned intraoperative extension of surgery |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Society for Obstetric Anesthesia and Perinatology |
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. doi: 10.1016/0952-8180(94)00040-b. — 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. doi: 10.1016/s0301-2115(96)02682-6. No abstract available. — 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. doi: 10.1016/j.ijoa.2007.01.012. 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. doi: 10.1034/j.1399-6576.2000.00512.x. — 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. doi: 10.1016/j.ajog.2003.08.014. — 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. doi: 10.1097/00000539-200104000-00038. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Platelet Aggregometry Light Transmission | Platelet Aggregometry uses measurements platelet rich blood or serum samples and activating agents to analyze the percent change in light transmission as a marker of platelet aggregation. | 15 minutes after dosing of placebo or ketorolac | |
Secondary | Thromboelastogram parameters including Reaction time (R) | Thromboelastogram parameters including Reaction time (R) | 15 minutes after dosing of placebo or ketorolac | |
Secondary | Thromboelastogram parameters including Angle (alpha) | Thromboelastogram parameters including Angle (alpha) | 15 minutes after dosing of placebo or ketorolac | |
Secondary | Thromboelastogram parameters including Kinetics (K) | Thromboelastogram parameters including Kinetics (K) | 15 minutes after dosing of placebo or ketorolac | |
Secondary | Thromboelastogram parameters including Maximum Amplitude (MA) | Thromboelastogram parameters including Maximum Amplitude (MA) | 15 minutes after dosing of placebo or ketorolac |
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