Minimally Invasive Surgical ProceduresPhase 4NCT07664956
Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy
A Phase 4 study testing Cyclobenzaprine in people with Minimally Invasive Surgical Procedures and Abnormal Uterine Bleeding, Unspecified, run by Christiana Care Health Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified, Adenomyosis of Uterus
- What is being tested?
- Cyclobenzaprine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age <18yo
- Male
- Pregnant, breastfeeding
- Non-English speaking
- Primary procedures other than laparoscopic hysterectomy
- Laparoscopic myomectomy
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kathryn Denny, MD contact
United States1 site
ChristianaCare Health System
Newark, Delaware, 19718
About this study
Official title: Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified, Adenomyosis of Uterus, Fibroid Uterus, Chronic Pelvic Pain, Endometriosis
- Being tested
- Cyclobenzaprine
- Keywords
- cyclobenzaprine, flexeril, hysterectomy, minimally invasive hysterectomy, pain control, multimodal pain control
- Medical subject headings
- Metrorrhagia, Adenomyosis, Leiomyoma, Endometriosis, Menorrhagia, Endometritis, Adnexal Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclobenzaprineDrug
5mg cyclobenzaprine q8hr for one week postoperatively after minimally invasive hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No additional intervention |
| Cyclobenzaprine | Experimental | 5mg cyclobenzaprine q8h for one week postoperatively Receives: Drug: Cyclobenzaprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Pain Score on Post Op Day 3
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.
Measured: 3 days postoperatively
Secondary outcomes (4)
Visual Analog Scale (VAS) Pain Scores on POD 0, 1, and 7
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.
Measured: 1 week
Cyclobenzaprine Side Effects as Part of Multimodal Analgesia
The study will collect data on and analyze and describe side effects that may be contributed to cyclobenzaprine use.
Measured: 1 week
Potential Contributors to Differences in Visual Analog Pain Scale Reported
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.
Measured: 1 week
Number of Alternative Postoperative Pain Medications Required to Achieve Adequate Analgesia
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Minimally Invasive Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664956
- Sponsor's protocol ID
- 50092
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be analyzed, only group data.
Publications
Khan NF, Bykov K, Barnett ML, Glynn RJ, Vine SM, Gagne JJ. Comparative Risk of Opioid Overdose With Concomitant Use of Prescription Opioids and Skeletal Muscle Relaxants. Neurology. 2022 Sep 27;99(13):e1432-e1442. doi: 10.1212/WNL.0000000000200904. Epub 2022 Jul 14.
PubMed 35835561Chen C, Hennessy S, Brensinger CM, Miano TA, Bilker WB, Dublin S, Chung SP, Horn JR, Tiwari A, Leonard CE. Comparative Risk of Injury with Concurrent Use of Opioids and Skeletal Muscle Relaxants. Clin Pharmacol Ther. 2024 Jul;116(1):117-127. doi: 10.1002/cpt.3248. Epub 2024 Mar 14.
PubMed 38482733Day LT, Jeanmonod RK. Serotonin syndrome in a patient taking Lexapro and Flexeril: a case report. Am J Emerg Med. 2008 Nov;26(9):1069.e1-3. doi: 10.1016/j.ajem.2008.03.028.
PubMed 19091289Braschi E, Garrison S, Allan GM. Cyclobenzaprine for acute back pain. Can Fam Physician. 2015 Dec;61(12):1074. No abstract available.
PubMed 26668287Tu J, Zhang C, Xie S, He J, Zhang H. Cyclobenzaprine-related adverse events: a comprehensive pharmacovigilance analysis using the FDA Adverse Event Reporting System. Front Med (Lausanne). 2025 Sep 22;12:1574395. doi: 10.3389/fmed.2025.1574395. eCollection 2025.
PubMed 41058614Choi JB, Kang K, Song MK, Seok S, Kim YH, Kim JE. Pain Characteristics after Total Laparoscopic Hysterectomy. Int J Med Sci. 2016 Jul 5;13(8):562-8. doi: 10.7150/ijms.15875. eCollection 2016.
PubMed 27499688Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.
PubMed 26757238Turner NF, Greco NJ. The rapid recovery study: Cyclobenzaprine's effect on recovery following joint arthroplasty. J Orthop. 2024 Mar 13;54:81-85. doi: 10.1016/j.jor.2024.03.016. eCollection 2024 Aug.
PubMed 38550387Ogura Y, Gum JL, Steele P, Crawford CH 3rd, Djurasovic M, Owens RK 2nd, Laratta JL, Davis E, Brown M, Daniels C, Dimar JR 2nd, Glassman SD, Carreon LY. Multi-modal pain control regimen for anterior lumbar fusion drastically reduces in-hospital opioid consumption. J Spine Surg. 2020 Dec;6(4):681-687. doi: 10.21037/jss-20-629.
PubMed 33447670van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM; Cochrane Back Review Group. Muscle relaxants for nonspecific low back pain: a systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1978-92. doi: 10.1097/01.BRS.0000090503.38830.AD.
PubMed 12973146Winchell GA, King JD, Chavez-Eng CM, Constanzer ML, Korn SH. Cyclobenzaprine pharmacokinetics, including the effects of age, gender, and hepatic insufficiency. J Clin Pharmacol. 2002 Jan;42(1):61-9. doi: 10.1177/0091270002042001007.
PubMed 11808825Verdiner R, Khurmi N, Choukalas C, Erickson C, Poterack K. Does adding muscle relaxant make post-operative pain better? a narrative review of the literature from US and European studies. Anesth Pain Med (Seoul). 2023 Oct;18(4):340-348. doi: 10.17085/apm.23055. Epub 2023 Oct 30.
PubMed 37919918Farishta A, Iancau A, Janis JE, Joshi GP. Use of Muscle Relaxants for Acute Postoperative Pain: A Practical Review. Plast Reconstr Surg Glob Open. 2024 Jul 1;12(7):e5938. doi: 10.1097/GOX.0000000000005938. eCollection 2024 Jul.
PubMed 38957722Ayogu CI, Javed A, Pompeu Dos Santos AF. Enhanced Recovery After Surgery vs Traditional Recovery Pathway After Minimally Invasive Hysterectomy for Benign Indications: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2025 Sep;32(9):775-783. doi: 10.1016/j.jmig.2025.04.003. Epub 2025 Apr 10.
PubMed 40216301Wang Y, Sun J, Yu K, Liu X, Liu L, Miao H, Li T. Virtual reality exposure reduce acute postoperative pain in female patients undergoing laparoscopic gynecology surgery: A Randomized Control Trial (RCT) study. J Clin Anesth. 2024 Oct;97:111525. doi: 10.1016/j.jclinane.2024.111525. Epub 2024 Jun 12.
PubMed 38870701
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07664956
- Acronym / sponsor ID
- 50092
- Conditions
- Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified, Adenomyosis of Uterus, Fibroid Uterus, Chronic Pelvic Pain, Endometriosis
- Keywords
- cyclobenzaprine, flexeril, hysterectomy, minimally invasive hysterectomy, pain control, multimodal pain control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No additional intervention |
| Cyclobenzaprine | Experimental | Drug: Cyclobenzaprine5mg cyclobenzaprine q8h for one week postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- Age <18yo
- Male
- Pregnant, breastfeeding
- Non-English speaking
- Primary procedures other than laparoscopic hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclobenzaprine5mg cyclobenzaprine q8hr for one week postoperatively after minimally invasive hysterectomy | Drug | Cyclobenzaprine |
Primary outcome
Visual Analog Scale (VAS) Pain Score on Post Op Day 3
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.
4 secondary outcomes
Visual Analog Scale (VAS) Pain Scores on POD 0, 1, and 7
Time frame: 1 week
Cyclobenzaprine Side Effects as Part of Multimodal Analgesia
Time frame: 1 week
Potential Contributors to Differences in Visual Analog Pain Scale Reported
Time frame: 1 week
Number of Alternative Postoperative Pain Medications Required to Achieve Adequate Analgesia
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 35835561Khan NF, Bykov K, Barnett ML, Glynn RJ, Vine SM, Gagne JJ. Comparative Risk of Opioid Overdose With Concomitant Use of Prescription Opioids and Skeletal Muscle Relaxants. Neurology. 2022 Sep 27;99(13):e1432-e1442. doi: 10.1212/WNL.0000000000200904. Epub 2022 Jul 14.
- Background: PubMed 38482733Chen C, Hennessy S, Brensinger CM, Miano TA, Bilker WB, Dublin S, Chung SP, Horn JR, Tiwari A, Leonard CE. Comparative Risk of Injury with Concurrent Use of Opioids and Skeletal Muscle Relaxants. Clin Pharmacol Ther. 2024 Jul;116(1):117-127. doi: 10.1002/cpt.3248. Epub 2024 Mar 14.
- Background: PubMed 19091289Day LT, Jeanmonod RK. Serotonin syndrome in a patient taking Lexapro and Flexeril: a case report. Am J Emerg Med. 2008 Nov;26(9):1069.e1-3. doi: 10.1016/j.ajem.2008.03.028.
- Background: PubMed 26668287Braschi E, Garrison S, Allan GM. Cyclobenzaprine for acute back pain. Can Fam Physician. 2015 Dec;61(12):1074. No abstract available.
- Background: PubMed 41058614Tu J, Zhang C, Xie S, He J, Zhang H. Cyclobenzaprine-related adverse events: a comprehensive pharmacovigilance analysis using the FDA Adverse Event Reporting System. Front Med (Lausanne). 2025 Sep 22;12:1574395. doi: 10.3389/fmed.2025.1574395. eCollection 2025.
- Background: PubMed 27499688Choi JB, Kang K, Song MK, Seok S, Kim YH, Kim JE. Pain Characteristics after Total Laparoscopic Hysterectomy. Int J Med Sci. 2016 Jul 5;13(8):562-8. doi: 10.7150/ijms.15875. eCollection 2016.
- Background: PubMed 26757238Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.
- Background: PubMed 38550387Turner NF, Greco NJ. The rapid recovery study: Cyclobenzaprine's effect on recovery following joint arthroplasty. J Orthop. 2024 Mar 13;54:81-85. doi: 10.1016/j.jor.2024.03.016. eCollection 2024 Aug.
- Background: PubMed 33447670Ogura Y, Gum JL, Steele P, Crawford CH 3rd, Djurasovic M, Owens RK 2nd, Laratta JL, Davis E, Brown M, Daniels C, Dimar JR 2nd, Glassman SD, Carreon LY. Multi-modal pain control regimen for anterior lumbar fusion drastically reduces in-hospital opioid consumption. J Spine Surg. 2020 Dec;6(4):681-687. doi: 10.21037/jss-20-629.
- Background: PubMed 12973146van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM; Cochrane Back Review Group. Muscle relaxants for nonspecific low back pain: a systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1978-92. doi: 10.1097/01.BRS.0000090503.38830.AD.
- Background: PubMed 11808825Winchell GA, King JD, Chavez-Eng CM, Constanzer ML, Korn SH. Cyclobenzaprine pharmacokinetics, including the effects of age, gender, and hepatic insufficiency. J Clin Pharmacol. 2002 Jan;42(1):61-9. doi: 10.1177/0091270002042001007.
- Background: PubMed 37919918Verdiner R, Khurmi N, Choukalas C, Erickson C, Poterack K. Does adding muscle relaxant make post-operative pain better? a narrative review of the literature from US and European studies. Anesth Pain Med (Seoul). 2023 Oct;18(4):340-348. doi: 10.17085/apm.23055. Epub 2023 Oct 30.
- Cyclobenzaprine DrugBankLink provided by the sponsor.
- Cyclobenzaprine PubChemLink provided by the sponsor.
- Cyclobenzaprine StatPearlsLink provided by the sponsor.
- Cyclobenzaprine FDA LabelLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual data will not be analyzed, only group data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathryn Denny, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclobenzaprine in people with Minimally Invasive Surgical Procedures and Abnormal Uterine Bleeding, Unspecified, run by Christiana Care Health Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret Wingo, MD (302-623-4410, margaret.wingo@christianacare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Pain Score on Post Op Day 3 (time frame: 3 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07664956, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.