Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study

NCT07766837 | Recruiting Phase 2 FDA Drug

• 1 other identifier: HHC-2026-0118
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative; Post Operative Analgesia; Urogynecologic Surgery

Keywords

post operative; tizanidine; urogynecology

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcome (PRO)

  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

Secondary Outcomes (4)

• Pain and Recovery-objective

  4-6 weeks post-operatively

• Pain and Recovery- subjective

  4-6 weeks

• Healthcare Utilization

  6 weeks post-operative

• Constipation

  2 weeks post-operative

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Other: Standard-of-Care Therapy

Intervention/Tizanidine

EXPERIMENTAL

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.

Drug: Tizanidine

Interventions

Tizanidine DRUG

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.

Intervention/Tizanidine

Standard-of-Care Therapy OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06103, United States

RECRUITING

Related Publications (12)

• 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.

  PMID: 41854462 RESULT

• 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 Sep 1;32(9):1120-1126. doi: 10.1097/SPV.0000000000001825.

  PMID: 41687037 RESULT

• 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.

  PMID: 11130605 RESULT

• 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.

  PMID: 16038812 RESULT

• 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.

  PMID: 8646957 RESULT

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 RESULT

• 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.

  PMID: 26555871 RESULT

• 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.

  PMID: 27521884 RESULT

• 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.

  PMID: 38529017 RESULT

• 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.

  PMID: 12269398 RESULT

• 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.

  RESULT

• 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.

  PMID: 20223444 RESULT

MeSH Terms

Interventions

tizanidine

Study Officials

• Elena Tunitsky, MD

  Hartford HealthCare

  STUDY DIRECTOR

• Sindhura Vallabhaneni, MD

  Hartford HealthCare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sindhura Vallabhaneni, MD

CONTACT

(860) 972-4338; Sindhura.Vallabhaneni@hhchealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control/standard-of-care arm 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. Intervention/treatment arm 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.

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 17, 2026
• Study Start: August 21, 2026
• Primary Completion (Estimated): July 29, 2028
• Study Completion (Estimated): July 29, 2028
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)