Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial

Phase 3

Completed

Conditions: Post-operative Pain
Post-partum Pain
Cesarean Section Complications

Interventions: Drug: Ketorolac

Registration Number: NCT03678675

Lead Sponsor: Tufts Medical Center

Brief Summary: To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section.

Detailed Description: This was a single-center, randomized, double-blind, parallel-group trial to assess pain management following cesarean section with increased ketorolac versus placebo. All patients undergoing cesarean section with neuraxial anesthesia received two doses of 30mg IV ketorolac postoperatively per hospital protocol and were then randomized to receive an additional four doses of 30 mg of IV ketorolac or placebo every 6 hours. The primary outcome was the total morphine milligram equivalents (MME) used in the first 72 postoperative hours. Secondary outcomes included the number of patients that used no opioid postoperatively, postoperative pain scores, postoperative change in hematocrit and creatinine, and postoperative satisfaction with inpatient care and pain management. A sample size of 74 per group (n=148) was planned.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 148

Inclusion Criteria

Women presenting for care at Tufts Medical Center as an outpatient in obstetrics clinic or on Labor and Delivery.
The subject must have had a cesarean section for any indication at Tufts Medical Center to be randomized to the study
The subject is willing to have a phone call follow up conversation 2 weeks after their surgery.

Exclusion Criteria

Patients with allergy to ketorolac, NSAIDS or aspirin
Patients with peptic ulcer disease, preexisting kidney or liver disease.
Duramorph is not used as the anesthetic for the spinal/epidural during the cesarean section.
Patient is hemodynamically unstable due to hemorrhage.
Patient requires therapeutic anticoagulation in the post-operative period
Patients with peripartum cardiomyopathy
Provider decision to exclude patient.
Patient diagnosis of chronic hypertension, gestational hypertension, preeclampsia, HELLP syndrome, or eclampsia
A study subject may participate in another research study while participating in this research study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac Protocol	Ketorolac	Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 6 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room or post-operative care unit.

Primary Outcome Measures

Name	Time	Method
The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours	Within 72 postoperative hours	The amount of MME's will be monitored for each group. MME's will be determined by the amount of opiate mediations administered. The MME value can range from 0 to typically 200 MME's, however there is no upper limit of measureable MME's. The MME's for each patient will be a sum of MME's administered throughout the course of the hospitalization.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Pain Score Greater Than 3	2 weeks	The patient reported pain scores will be recorded and analyzed for each group. The Pain Score is determined by the patient using a visual analog scale with a range from 0-10, where 0 is no pain at all and 10 is the worst pain imaginable for the patient. Pain scores were collected by postpartum nursing staff per institutional policy. The number of patients with a pain score greater than 3 will be reported. A pain score greater than 3 was chosen as a cutoff as this is the pain score at which an opioid may be indicated for analgesia at our institution.
The Number of Patients That Used no Opioid Postoperatively	Within 72 post-operative hours	The number of patients in each arm that required no opioids for pain control postoperatively.
Postoperative Change in Hematocrit	Change in pre-operative hematocrit to POD1 hematocrit	The change in patient hematocrit from baseline to POD1
Change in Creatinine	Change in creatinine from POD1 to POD2	The change in patient's creatinine from POD1 to POD2
Postoperative Satisfaction With Inpatient Pain Control	Inpatient pain control satisfaction as reported at two weeks postpartum	Two weeks after cesarean section, subjects were contacted by telephone to complete a survey on postpartum pain management. At least three attempts were made to contact subjects by telephone. In the follow-up phone call, patients were asked to rate their satisfaction with their postpartum care: very satisfied, satisfied, neutral, dissatisfied, or very dissatisfied. The number below describes the number of patients who reported they were "very satisfied" with their care.
Postoperative Satisfaction With Their Inpatient Postpartum Care.	Satisfaction with inpatient care as reported at two weeks postpartum	Two weeks after cesarean section, subjects were contacted by telephone to complete a survey on their overall postpartum care. At least three attempts were made to contact subjects by telephone. In the follow-up phone call, patients were asked to rate their satisfaction with their postpartum care: very satisfied, satisfied, neutral, dissatisfied, or very dissatisfied. The number below describes the number of patients that reported they were very satisfied with their care.