Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study (TIPS)
The goal of this clinical trial is to evaluate whether adding tizanidine to the standard postoperative pain regimen improves recovery after pelvic reconstructive surgery in adult women. The main questions it aims to answer are:
Does postoperative tizanidine improve patient-reported recovery 4-6 weeks after surgery? Does tizanidine reduce postoperative pain, opioid use, constipation, and healthcare utilization while improving functional recovery?
Researchers will compare standard postoperative care plus tizanidine with standard postoperative care alone to determine whether tizanidine improves postoperative recovery.
Participants will:
- Be randomly assigned to receive either standard postoperative pain management alone or standard postoperative pain management plus tizanidine for 2 weeks after surgery.
- Complete electronic surveys before surgery, 1-2 days after surgery, 2 weeks after surgery, and 4-6 weeks after surgery to assess pain, recovery, activity, and bowel function.
- Allow researchers to review information from their electronic medical record, including healthcare utilization and postoperative outcomes, during the 4-6 weeks following surgery.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
This pilot study evaluates the effectiveness of postoperative tizanidine as an adjunct to existing postoperative pain regimens for patients undergoing pelvic reconstructive surgery. Enhanced Recovery After Surgery (ERAS) pathways in gynecologic surgery have been associated with decreased postoperative pain, need for analgesia, complications, re-admissions, and length of hospital stay, with an emphasis on multimodal regimens and minimizing opioid administration. However, postoperative pain after urogynecologic surgery remains multifactorial and may be related to pelvic floor muscle spasm or dysfunction following surgery. Tizanidine, a skeletal muscle relaxant that acts centrally as an alpha-2 adrenergic agonist, has the unique ability to address pelvic floor muscle spasm and its contribution to postoperative pain, while having fewer adverse events in older patients compared to other skeletal muscle relaxants. Although one randomized control trial demonstrated favorable effects of tizanidine on postoperative pain and recovery after inguinal hernia repair, no previous studies have examined its role in postoperative recovery and pain control for gynecologic patients.
The study will be conducted as a prospective, longitudinal, non-blinded, two-arm randomized controlled trial comparing the postoperative experience and pain control of patients utilizing tizanidine to those who are not taking tizanidine. Eligible participants include English- or Spanish-speaking women aged 18-89 years undergoing apical suspension with concomitant vaginal repairs. Participants will be randomized in a 1:1 ratio to either a control arm receiving standard ERAS postoperative care or an intervention arm receiving standard ERAS care plus tizanidine 4 mg three times daily for two weeks postoperatively.
Data collection will include demographic, medical, surgical, and healthcare utilization information, as well as validated surveys administered preoperatively, on postoperative day 1-2, at 2 weeks, and at 4-6 weeks postoperatively. The primary outcome is patient-reported outcome (PRO) assessed at 4-6 weeks postoperatively. Secondary outcomes include pain and recovery measures, opioid use, constipation, and healthcare utilization including readmissions, ED visits, telephone encounters, patient portal messages, and additional pain medication prescriptions. The study aims to recruit 186 patients to achieve 150 completed participants. Findings may help investigate a postoperative pain regimen that could decrease opioid use and improve postoperative recovery in urogynecologic patients.
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Sindhura Vallabhaneni, MD
- Numer telefonu: (860) 972-4338
- E-mail: Sindhura.Vallabhaneni@hhchealth.org
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
female, age ≥18 and ≤89 years old
- any race/ethnicity
- English and/or Spanish fluency
undergoing apical suspension:
- sacrocolpopexy (laparoscopic or robotic)
- uterosacral ligament suspension (vaginal, laparoscopic, or robotic)
- sacrospinous ligament fixation
- iliococcygeus suspension
- surgery being performed at Hartford Hospital
Exclusion Criteria:
male
- age <18 or ≥90 years old
- pregnant
- breastfeeding
- documented diagnosis of hypotension in EMR problem list, BP in office or at pre-op PAC (confirmed on repeat) to be systolic <100 mm Hg and/or diastolic <70 mm Hg
- known intolerance or sensitivity to tizanidine
current use of:
- CYP1A2 inhibitor:
- clonidine (alpha-2 agonist) antihypertensive
- opioid
- muscle relaxant
pre-existing
- hepatic impairment as defined as transaminitis with ALT or AST >2x upper limit of normal
- diagnoses of cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease (NAFLD)
- renal impairment as defined by creatinine clearance <25 mL/min
- obstructive sleep apnea
- non-English or non-Spanish speaking
- past opioid dependence
- concurrent diagnosis of malignancy
- concurrent surgery apart from pelvic reconstructive surgery with another specialty
- unable/unwilling to consent to participate
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Control
Participants will follow standard-of-care -- the current standard ERAS protocol including preop medication management with Tylenol and Celebrex (unless contraindicated) and postoperative outpatient pain regimen of scheduled Tylenol, Motrin, and as-needed standard amounts of opioid medication.
A placebo will not be used in this study.
|
Participants will follow standard-of-care -- the current standard ERAS protocol including preop medication management with Tylenol and Celebrex (unless contraindicated) and postoperative outpatient pain regimen of scheduled Tylenol, Motrin, and as-needed standard amounts of opioid medication.
A placebo will not be used in this study.
|
|
Eksperymentalny: Intervention/Tizanidine
Participants will follow standard-of-care -- the current standard ERAS protocol above -- and will be given tizanidine 4 mg scheduled three times a day (12 mg/day) for two weeks postoperatively.
|
Participants will follow standard-of-care -- the current standard ERAS protocol above -- and will be given tizanidine 4 mg scheduled three times a day (12 mg/day) for two weeks postoperatively.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Patient Reported Outcome (PRO)
Ramy czasowe: 4-6 weeks post-operatively
|
Patient-reported outcome (PRO) assessed at 4-6 weeks post-operatively is the primary outcome. The PRO is a single question survey "To what extent do you feel physically recovered after surgery" that identifies a patient's perceived post-operative recovery with recent publication of content validity in urogynecology research. Answer choices are "I don't feel at all recovered," "I feel recovered up to 25%," "I feel recovered up to 50%," "I feel recovered up to 75%," and "I feel fully recovered." |
4-6 weeks post-operatively
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Pain and Recovery-objective
Ramy czasowe: 4-6 weeks post-operatively
|
Composite outcome assessed at 4-6 weeks post-operatively and includes pain and recovery according to objective and subjective criteria: objective criteria -- morphine milligram equivalents (MME) used
|
4-6 weeks post-operatively
|
|
Pain and Recovery- subjective
Ramy czasowe: 4-6 weeks
|
Composite outcome assessed at 4-6 weeks post-operatively and includes pain and recovery according to objective and subjective criteria: subjective criteria -- validated surveys (AAS, GSR, PRO, BPI-SF) Activity Assessment Scale, min score 0, max score 100, higher score is better function Global Surgical Recovery, min score 0%, max score 100%, higher score is better recovery Brief Pain Inventory-Short Form, min score 0, max score 10 per item. higher scire is worse pain |
4-6 weeks
|
|
Healthcare Utilization
Ramy czasowe: 6 weeks post-operative
|
Healthcare utilization will be assessed by readmission, ED visits, telephone visits, patient portal messages, additional pain meds prescribed (including refills) within 4-6 weeks postoperatively.
|
6 weeks post-operative
|
|
Constipation
Ramy czasowe: 2 weeks post-operative
|
Constipation will be measured with constipation scoring system (CSS). CSS, min score 0, max score 30, higher score means worse constipation |
2 weeks post-operative
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Elena Tunitsky, MD, Hartford Healthcare
- Główny śledczy: Sindhura Vallabhaneni, MD, Hartford Healthcare
Publikacje i pomocne linki
Publikacje ogólne
- Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Agachan F, Chen T, Pfeifer J, Reissman P, Wexner SD. A constipation scoring system to simplify evaluation and management of constipated patients. Dis Colon Rectum. 1996 Jun;39(6):681-5. doi: 10.1007/BF02056950.
- Kleinbeck SV. Self-reported at-home postoperative recovery. Res Nurs Health. 2000 Dec;23(6):461-72. doi: 10.1002/1098-240X(200012)23:63.0.CO;2-S.
- Kalogera E, Dowdy SC. Enhanced Recovery Pathway in Gynecologic Surgery: Improving Outcomes Through Evidence-Based Medicine. Obstet Gynecol Clin North Am. 2016 Sep;43(3):551-73. doi: 10.1016/j.ogc.2016.04.006.
- Ashmore S, Samsel T, Collins SA, Kenton K, Lewicky-Gaupp C, Mueller MG. Patient Reported Recovery After Surgery. Urogynecology (Phila). 2026 Apr 1;32(4):391-398. doi: 10.1097/SPV.0000000000001815.
- Mueller MG, Ganz MG, Siddiqui NY, Sung V, Andy U, Menefee S, Dounoucos V, Griffith JW, Schaffer J, Mazloomdoost D, Kenton K; Pelvic Floor Disorders Network. Content Validity of a Patient-Reported Measure of Postoperative Recovery. Urogynecology (Phila). 2026 Feb 12:10.1097/SPV.0000000000001825. doi: 10.1097/SPV.0000000000001825. Online ahead of print.
- McCarthy M Jr, Jonasson O, Chang CH, Pickard AS, Giobbie-Hurder A, Gibbs J, Edelman P, Fitzgibbons R, Neumayer L. Assessment of patient functional status after surgery. J Am Coll Surg. 2005 Aug;201(2):171-8. doi: 10.1016/j.jamcollsurg.2005.03.035.
- Yazicioglu D, Caparlar C, Akkaya T, Mercan U, Kulacoglu H. Tizanidine for the management of acute postoperative pain after inguinal hernia repair: A placebo-controlled double-blind trial. Eur J Anaesthesiol. 2016 Mar;33(3):215-22. doi: 10.1097/EJA.0000000000000371.
- Zhu LL, Wang YH, Zhou Q. Tizanidine: Advances in Pharmacology & Therapeutics and Drug Formulations. J Pain Res. 2024 Mar 21;17:1257-1271. doi: 10.2147/JPR.S461032. eCollection 2024.
- Jain NK, Kulkarni SK, Singh A. Modulation of NSAID-induced antinociceptive and anti-inflammatory effects by alpha2-adrenoceptor agonists with gastroprotective effects. Life Sci. 2002 May 3;70(24):2857-69. doi: 10.1016/s0024-3205(02)01549-7.
- U.S. Food and Drug Administration. Zanaflex (tizanidine hydrochloride) prescribing information. FDA; October 4, 2013. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021447s011_020397s026lbl.pdf. Accessed January 26, 2026.
- Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in inpatient prolapse procedures in the United States, 1979-2006. Am J Obstet Gynecol. 2010 May;202(5):501.e1-7. doi: 10.1016/j.ajog.2010.01.017. Epub 2010 Mar 11.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HHC-2026-0118
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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