Intra-Operative Corticosteroid Injection During Arthroscopic Shoulder Surgery

NCT02867904 | Terminated Phase 4

• 1 other identifier: 2016.128
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy of intra-operative subacromial corticosteroid injections in patients undergoing arthroscopic shoulder surgery on quality of life scores and activity level when compared to a control group.

Conditions

Arthroscopic Shoulder Surgery; Intra-articular Debridement; Subacromial Decompression; Acromioplasty; Acromioclavicular Joint Resection

Outcome Measures

Primary Outcomes (1)

• Disabilities of the Arm, Shoulder, and Hand Survey (DASH)

  1 year

Secondary Outcomes (4)

• Active Range of Motion of Shoulder

  Pre-operatively and Post-operatively at 2 weeks, 6 weeks, and 3 months

• Simple Assessment Numeric Evaluation (SANE)

  1 year

• Western Ontario Rotator Cuff Survey (WORC)

  1 year

• Marx Shoulder Activity Level Survey (MARX)

  1 year

Study Arms (2)

Group A

PLACEBO COMPARATOR

After arthroscopic surgery the control group (Group A) will undergo a subacromial marcaine injection (standard of care).

Drug: Marcaine (4ml 0.5%, injection)

Group B

EXPERIMENTAL

After arthroscopic surgery the experimental group (Group B) will undergo a subacromial corticosteroid injection+marcaine.

Drug: Methylprednisolone (40 mg depomedrol, 1ml, injection); Drug: Marcaine (4ml 0.5%, injection)

Interventions

Methylprednisolone (40 mg depomedrol, 1ml, injection) DRUG

Experimental Drug

Group B

Marcaine (4ml 0.5%, injection) DRUG

Control

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years-old or older
• Male patients
• Female patients
• Patients able to speak and understand written English
• Patients presenting to the orthopedic institute clinic with shoulder pain and necessitating the procedure of arthroscopic shoulder surgery
• Specific arthroscopic procedures include: intra-articular debridement, decompression, acromioplasty, and acromioclavicular joint resection

You may not qualify if:

• Patients undergoing arthroscopic shoulder surgery that includes other interventions (i.e. rotator cuff repair; labral repair, etc)
• Patients with adhesive capsulitis
• Patients with significant cervical spine symptoms and/or pathology
• Patients having a history of receiving chronic pain treatment
• Patients who are currently pregnant or who become pregnant before surgery
• Patients who cannot speak or understand written english
• Patients who are under the age of 18 years of age

Sponsors & Collaborators

• Peter Chang: lead

Study Sites (1)

Orthopedic Institute

Sioux Falls, South Dakota, 57105, United States

Location

Related Publications (19)

• Bhattacharjee DP, Biswas C, Haldar P, Ghosh S, Piplai G, Rudra JS. Efficacy of intraarticular dexamethasone for postoperative analgesia after arthroscopic knee surgery. J Anaesthesiol Clin Pharmacol. 2014 Jul;30(3):387-90. doi: 10.4103/0970-9185.137273.

  PMID: 25190949 BACKGROUND

• Kim YJ, Lee GY, Kim DY, Kim CH, Baik HJ, Heo S. Dexamathasone added to levobupivacaine improves postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Feb;62(2):130-4. doi: 10.4097/kjae.2012.62.2.130. Epub 2012 Feb 20.

  PMID: 22379567 BACKGROUND

• Stan T, Goodman EJ, Bravo-Fernandez C, Holbrook CR. Adding methylprednisolone to local anesthetic increases the duration of axillary block. Reg Anesth Pain Med. 2004 Jul-Aug;29(4):380-1. doi: 10.1016/j.rapm.2004.03.006. No abstract available.

  PMID: 15305267 BACKGROUND

• Attardi B, Takimoto K, Gealy R, Severns C, Levitan ES. Glucocorticoid induced up-regulation of a pituitary K+ channel mRNA in vitro and in vivo. Recept Channels. 1993;1(4):287-93.

  PMID: 8081726 BACKGROUND

• Singelyn FJ, Lhotel L, Fabre B. Pain relief after arthroscopic shoulder surgery: a comparison of intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg. 2004 Aug;99(2):589-92, table of contents. doi: 10.1213/01.ANE.0000125112.83117.49.

  PMID: 15271745 BACKGROUND

• Cancienne JM, Gwathmey FW, Werner BC. Intraoperative Corticosteroid Injection at the Time of Knee Arthroscopy Is Associated With Increased Postoperative Infection Rates in a Large Medicare Population. Arthroscopy. 2016 Jan;32(1):90-5. doi: 10.1016/j.arthro.2015.09.003. Epub 2015 Nov 6.

  PMID: 26553960 BACKGROUND

• Arroll B, Goodyear-Smith F. Corticosteroid injections for osteoarthritis of the knee: meta-analysis. BMJ. 2004 Apr 10;328(7444):869. doi: 10.1136/bmj.38039.573970.7C. Epub 2004 Mar 23.

  PMID: 15039276 BACKGROUND

• Koyonos L, Yanke AB, McNickle AG, Kirk SS, Kang RW, Lewis PB, Cole BJ. A randomized, prospective, double-blind study to investigate the effectiveness of adding DepoMedrol to a local anesthetic injection in postmeniscectomy patients with osteoarthritis of the knee. Am J Sports Med. 2009 Jun;37(6):1077-82. doi: 10.1177/0363546508331204. Epub 2009 Mar 11.

  PMID: 19279226 BACKGROUND

• Highgenboten CL, Jackson AW, Meske NB. Arthroscopy of the knee. Ten-day pain profiles and corticosteroids. Am J Sports Med. 1993 Jul-Aug;21(4):503-6. doi: 10.1177/036354659302100404.

  PMID: 8368408 BACKGROUND

• Armstrong RW, Bolding F. Septic arthritis after arthroscopy: the contributing roles of intraarticular steroids and environmental factors. Am J Infect Control. 1994 Feb;22(1):16-8. doi: 10.1016/0196-6553(94)90086-8.

  PMID: 8172371 BACKGROUND

• Fontana C, Di Donato A, Di Giacomo G, Costantini A, De Vita A, Lancia F, Caricati A. Postoperative analgesia for arthroscopic shoulder surgery: a prospective randomized controlled study of intraarticular, subacromial injection, interscalenic brachial plexus block and intraarticular plus subacromial injection efficacy. Eur J Anaesthesiol. 2009 Aug;26(8):689-93. doi: 10.1097/eja.0b013e32832d673e.

  PMID: 19593887 BACKGROUND

• HOLLANDER JL, BROWN EM Jr, JESSAR RA, BROWN CY. Hydrocortisone and cortisone injected into arthritic joints; comparative effects of and use of hydrocortisone as a local antiarthritic agent. J Am Med Assoc. 1951 Dec 22;147(17):1629-35. doi: 10.1001/jama.1951.03670340019005. No abstract available.

  PMID: 14880415 BACKGROUND

• Sun Y, Chen J, Li H, Jiang J, Chen S. Steroid Injection and Nonsteroidal Anti-inflammatory Agents for Shoulder Pain: A PRISMA Systematic Review and Meta-Analysis of Randomized Controlled Trials. Medicine (Baltimore). 2015 Dec;94(50):e2216. doi: 10.1097/MD.0000000000002216.

  PMID: 26683932 BACKGROUND

• Tandoc MN, Fan L, Kolesnikov S, Kruglov A, Nader ND. Adjuvant dexamethasone with bupivacaine prolongs the duration of interscalene block: a prospective randomized trial. J Anesth. 2011 Oct;25(5):704-9. doi: 10.1007/s00540-011-1180-x. Epub 2011 Jun 17.

  PMID: 21681533 BACKGROUND

• Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.

  PMID: 23587875 BACKGROUND

• Zheng XQ, Li K, Wei YD, Tie HT, Yi XY, Huang W. Nonsteroidal anti-inflammatory drugs versus corticosteroid for treatment of shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Oct;95(10):1824-31. doi: 10.1016/j.apmr.2014.04.024. Epub 2014 May 16.

  PMID: 24841629 BACKGROUND

• Westermann RW, Pugely AJ, Ries Z, Amendola A, Martin CT, Gao Y, Wolf BR. Causes and Predictors of 30-Day Readmission After Shoulder and Knee Arthroscopy: An Analysis of 15,167 Cases. Arthroscopy. 2015 Jun;31(6):1035-1040.e1. doi: 10.1016/j.arthro.2015.03.029.

  PMID: 26048765 BACKGROUND

• Bjornholdt KT, Monsted PN, Soballe K, Nikolajsen L. Dexamethasone for pain after outpatient shoulder surgery: a randomised, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2014 Jul;58(6):751-8. doi: 10.1111/aas.12333. Epub 2014 May 13.

  PMID: 24825530 BACKGROUND

• Hagiwara Y, Sugaya H, Takahashi N, Kawai N, Ando A, Hamada J, Itoi E. Effects of intra-articular steroid injection before pan-capsular release in patients with refractory frozen shoulder. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1536-1541. doi: 10.1007/s00167-014-2936-2. Epub 2014 Mar 19.

  PMID: 24643358 BACKGROUND

MeSH Terms

Interventions

Methylprednisolone; Injections; Bupivacaine

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Student Researcher

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 16, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

US (1)