Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study

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.

Timeline

Start

2026-08-21

Primary completion

2028-07-29

Completion

2028-07-29

Publications

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

Drugs

Indications

No indication recorded.