Abnormal Uterine Bleeding, Unspecified, Adenomyosis of Uterus, Adnexal Diseases, Chronic Pelvic Pain, Endometriosis, Endometritis, Fibroid Uterus, Menorrhagia, Minimally Invasive Surgical Procedures
Conditions
Keywords
cyclobenzaprine, flexeril, hysterectomy, minimally invasive hysterectomy, pain control, multimodal pain control
Brief summary
Typical postoperative pain control after minimally invasive hysterectomy includes ibuprofen, acetaminophen, and a short course of narcotics. The purpose of this study is to see if adding cyclobenzaprine to this regime improves pain control and lessens narcotic use.
Detailed description
The purpose of this study is to gather more information on cyclobenzaprine as part of postoperative pain control. Cyclobenzaprine, aka Flexeril®, is NOT an experimental drug and is already approved by the Food and Drug Administration (FDA) for acute, painful muscle spasms. It is commonly used for muscle-related pain disorders. This research is being done because prior studies have shown that cyclobenzaprine helps with pain due to muscle spasms. Some studies showed that cyclobenzaprine does help reduce pain scores in patients undergoing abdominal or joint surgery, but the studies are very limited. This study will see if cyclobenzaprine can be used to decrease post-operative pain in patients undergoing minimally invasive hysterectomy.
Interventions
DRUGCyclobenzaprine
5mg cyclobenzaprine q8hr for one week postoperatively after minimally invasive hysterectomy
Sponsors
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18yo * Female * English speaking * Undergoing (robotic assisted or classic) total laparoscopic hysterectomy ± unilateral or bilateral salpingectomy ± unilateral or bilateral oophorectomy * If other procedures such as lysis of adhesions, excision of endometriosis, or ureterolysis are indicated based on intraoperative evaluation, those patients may still be included * Surgery took place at ChristianaCare Hospitals * No allergies or contraindications to standard of care post operative pain medications (acetaminophen, NSAIDs, narcotics) or cyclobenzaprine
Exclusion criteria
* Age \<18yo * Male * Pregnant, breastfeeding * Non-English speaking * Primary procedures other than laparoscopic hysterectomy * Laparoscopic myomectomy * Laparoscopic resection of endometriosis * Laparoscopic unilateral or bilateral salpingectomy ± unilateral or bilateral oophorectomy ± unilateral or bilateral cystectomy without hysterectomy * Hysteroscopic procedures * Bartholin gland marsupialization * Operations that are scheduled as or converted to the open approach * Procedures with planned or unplanned bladder or bowel surgery * Allergies or contraindications to standard post operative pain control medications (acetaminophen, NSAIDs, narcotics), such as kidney or liver damage/failure, bariatric surgery, history of gastric ulcer, etc. * Chronic pain issues, whether self-diagnosed or by a physician, currently undergoing management * Currently undergoing medication assisted treatment for opioid use disorder * Currently using opioids consistently * Allergies or contraindications to cyclobenzaprine: * Absolute: use of MAO inhibitors within 14 days, recent heart attack, congestive heart failure, heart block or other conduction abnormalities, cardiac arrhythmias, hyperthyroidism, history of serotonin syndrome * Allergies or contraindications to inactive ingredients in Flexeril, such as lactose * Patient's receiving gabapentin at baseline or postoperatively, due to potential sedating effects, or other sedating drugs such as scheduled benzodiazepines and barbiturates
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score on Post Op Day 3 | 3 days postoperatively | The primary objective of the study will be to assess pain scores via Visual Analog Scale (VAS) on Post Op Day 3 compared between the control group vs cyclobenzaprine group. Ratings will be from 0 to 10, which are associated with visual cues to aid in selection. As stated above, VAS pain scores will be collected electronically via REDCap. The survey will be distributed via Doximity text or patient portal message. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Scores on POD 0, 1, and 7 | 1 week | Visual Analog Scale (VAS) is rated 0-10. The study is not designed, nor powered, to test any other hypotheses other than the primary outcome. However, the study will collect data on analgesic use over a one-week period. In addition to the primary outcome of pain scores on POD3, pain scores will be collected on post op days 0, 1, and 7. |
| Cyclobenzaprine Side Effects as Part of Multimodal Analgesia | 1 week | The study will collect data on and analyze and describe side effects that may be contributed to cyclobenzaprine use. |
| Potential Contributors to Differences in Visual Analog Pain Scale Reported | 1 week | The researchers will also collect data to determine if any of the following variables contribute to changes in pain scores and/or requirements for analgesia: size of uterus, indication for operation, pathology, length of operation, blood loss, complications, and other pelvic surgeries performed. |
| Number of Alternative Postoperative Pain Medications Required to Achieve Adequate Analgesia | 1 week | The researchers will determine if adding another adjunctive medication (i.e. cyclobenzaprine) for pain affects the compliance of post-operative medications (such as ibuprofen, acetaminophen, and oxycodone). Specifically, we will determine the number of oxycodone tabs left at the end of the first week postoperatively and ask the patient to report if they took ibuprofen and acetaminophen scheduled, as prescribed. |
Countries
United States
Contacts
CONTACTMargaret Wingo, MD
CONTACTKathryn Denny, MD
Outcome results
None listed