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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Sindhura Vallabhaneni, MD
- 電話番号：(860) 972-4338
- メール：Sindhura.Vallabhaneni@hhchealth.org
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Reported Outcome (PRO)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain and Recovery-objective
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Elena Tunitsky, MD、Hartford Healthcare
- 主任研究者：Sindhura Vallabhaneni, MD、Hartford Healthcare
出版物と役立つリンク
一般刊行物
- 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.
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