ChristianaCare Health System
Newark, Delaware, 19718, United States
NCT Number: NCT07664956
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Phase 4
Newark, Delaware, 19718, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5mg cyclobenzaprine q8hr for one week postoperatively after minimally invasive hysterectomy
Time frame: 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.
Time frame: 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.
Time frame: 1 week
The study will collect data on and analyze and describe side effects that may be contributed to cyclobenzaprine use.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
The researchers will determine if having the addition of cyclobenzaprine as part of postoperative multimodal pain management correlates with the number of times the patient interacts with the health system postoperatively, including but not limited to communications, office visits, ER visits, and readmissions.
Contact information is provided by the study sponsor or research team.
Christiana Care Health Services
Other
Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06731998
Agnosia, Biliary Tract Cancer
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT07370116
Minimally Invasive Surgical Procedures, Nasogastric Tube Decompression
Beijing, China
View Trial DetailsNCT06295094
Chemotherapy, Adjuvant, Digestive System Diseases
Duarte, California, United States
View Trial DetailsNCT07671963
Bone Substitutes, Minimally Invasive Surgical Procedures
Cagliari, Italy
View Trial Details