Clinical trial NCT04444830: Sprix for Postoperative Pain Control Following Gynecologic Surgery
Official title: Can Intranasal Ketorolac Tromethamine Prescribed Postoperatively After Major Female Pelvic Reconstructive Surgery Reduce Consumption of Prescribed Narcotics?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Post Operative Pain Control
Narcotic Use
Pelvic Organ Prolapse
Urinary Incontinence , Stress
Surgery
Keywords: Minimally Invasive Gynecologic Surgery
Female Pelvic Reconstructive Surgery
Post Operative Pain Control
Narcotic Reduction
Opioid Reduction
Pelvic Organ Prolapse
Stress Urinary Incontinence
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-center, non-blinded, randomized control trial.
Primary purpose: TREATMENT

Brief summary: The ongoing opioid epidemic has altered both how physicians prescribe narcotics and patients' perceptions of those prescriptions. Along with increased scrutiny regarding the quantity of opioids that be may prescribed after acute injury, for chronic conditions and following surgery the healthcare industry as a whole continues to search for alternative medications that provide adequate pain relief and have a reduced tendency for abuse/dependence/addition. To that end this study has the following aims:

1. To evaluate the amount of opioids consumed following minimally invasive, female pelvic surgery when patients' postoperative pain is managed via:

   1. Acetaminophen plus Ibuprofen plus breakthrough pain opioids (Standard protocol)
   2. Acetaminophen plus Intranasal Ketorolac Tromethamine plus opioids for breakthrough pain (Sprix protocol)
2. Patient satisfaction with the aforementioned methods
3. Evaluate and compare pain scores via validated questionnaire

Hypothesis:

Primary:

1. Patients prescribed intranasal Ketorolac (Sprix protocol) will consume significantly less Morphine Milliequivalents (mEqs) of narcotics compared to the standard protocol following minimally invasive female pelvic surgery.

Secondary:

1. Patients in the Sprix protocol will have lower Visual Analog Scale (VAS) measures of pain which will be measured on a 0-10 scale where 0 denotes no pain and 10 denotes maximum experience of pain
2. Patients in the Sprix protocol will have lower numeric pain score and on POD#4
3. Patients in the Sprix protocol will have higher Quality of Recovery 40 (QoR-40 )scores on POD#1
4. Patients in the Sprix protocol will have higher QoR-40 scores on POD#4
5. Patients will not have any significant difference in overall surgical satisfaction on POD#1 and POD#4 using a numerical satisfaction score
6. Patients in the Sprix protocol will be more likely to consume no narcotics at all once discharged to home


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years of age
2. Weight ≥ 110lbs
3. English Speaking and Reading
4. All consecutive, consenting female patients undergoing Pelvic Organ Prolapse (POP) surgery - vaginal prolapse surgery, laparoscopic vaginal prolapse surgery or robotic assisted vaginal prolapse surgery - with or without Bilateral or Unilateral Salpingoopherectomy, with or without concomitant hysterectomy, with or without urinary anti-incontinence surgery

Exclusion Criteria:

1. Patients taking opioids chronically at the time of surgery
2. History of Coronary Artery Bypass Graft (CABG)
3. History of peptic ulcer disease or bleeding in the stomach or intestines
4. History of asthma attack, hives, or other allergic reaction with aspirin or any other Non-Steroidal Anti-inflammatory Drug (NSAID)
5. Uncontrolled hypertension at the time of consent and/or surgery
6. History of renal impairment as defined by blood creatinine of 1.1 or greater at any time

Primary outcomes:
measure: Morphine mEqs
timeFrame: As measured from the day of surgery to 4 days post operative
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Day of surgery to 4 days postoperative
measure: Patient's perception of current pain
timeFrame: Day of surgery to 4 days postoperatively
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
References:
citation: Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010 Aug;26(8):1915-23. doi: 10.1185/03007995.2010.495564.
citation: Pergolizzi JV Jr, Taylor R Jr, Raffa RB. Intranasal ketorolac as part of a multimodal approach to postoperative pain. Pain Pract. 2015 Apr;15(4):378-88. doi: 10.1111/papr.12239. Epub 2014 Aug 28.
citation: Pollack CV Jr, Diercks DB, Thomas SH, Shapiro NI, Fanikos J, Mace SE, Rafique Z, Todd KH. Patient-reported Outcomes from A National, Prospective, Observational Study of Emergency Department Acute Pain Management With an Intranasal Nonsteroidal Anti-inflammatory Drug, Opioids, or Both. Acad Emerg Med. 2016 Mar;23(3):331-41. doi: 10.1111/acem.12902.
citation: Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008 Dec;107(6):2025-31. doi: 10.1213/ane.0b013e318188b736.