Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial

NCT06917118 | Not Yet Recruiting

• 1 other identifier: 2501339638
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy). The study groups are:

• Control group: standard pain control with opioids
• Experimental group: multimodal non-opioid pain control Study Outcomes are:
• VAS pain scores (7 days),
• Total opioid usage
• Patient satisfaction
• Adverse events We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.

Conditions

Pain Management

Keywords

WALANT; Multimodal analgesia; Nonopioid pain management; VAS pain scores

Outcome Measures

Primary Outcomes (3)

• VAS Pain Scores

  VAS pain scores will be assessed using a patient- completed VAS pain questionnaire until 7 days post-op. Patients will take the questionnaire home and report pain scores in the morning and in the afternoon every day for a week.

  From enrollment to the end of treatment at 7 days

• Patient Satisfaction

  Patient satisfaction will be assessed using the Patient Satisfaction Questionnaire Short Form (PSQ-18)

  From enrollment to the end of treatment at 7 days

• Total Opioid Usage

  Will be reported in as morphine milligram equivalents (MMEs)

  From enrollment to the end of treatment at 7 days

Secondary Outcomes (3)

• Breakthrough Pain

  From enrollment to the end of treatment at 7 days

• Length of Treatment

  From enrollment to the end of treatment at 7 days

• Indication for WALANT surgery

  From enrollment to the end of treatment at 7 days

Study Arms (2)

Standard Postoperative opioid analgesia

ACTIVE COMPARATOR

10 pills of 5mg oxycodone Q4hrs as needed

Drug: Oxycodone 5mg taken first

Postoperative Opioid-sparing Multimodal analgesia

EXPERIMENTAL

30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs. Will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain

Drug: Acetaminophen; Drug: Naproxen Tablets, 500 mg; Drug: OxyCODONE 5 mg Oral Tablet

Interventions

Oxycodone 5mg taken first DRUG

10 pills of 5mg oxycodone Q4hrs as needed

Standard Postoperative opioid analgesia

Acetaminophen DRUG

30 pills of 500mg acetaminophen Q4hrs

Postoperative Opioid-sparing Multimodal analgesia

Naproxen Tablets, 500 mg DRUG

30 pills of 500mg naproxen Q4hrs

Postoperative Opioid-sparing Multimodal analgesia

OxyCODONE 5 mg Oral Tablet DRUG

Only used for breakthrough pain

Postoperative Opioid-sparing Multimodal analgesia

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 21-70 years of age undergoing outpatient hand surgery
• Patients undergoing surgery with WALANT technique
• Patients who provide written informed consent

You may not qualify if:

• Patients aged 20 and younger, or 71 and older
• Patient with chronic pain requiring opioid use
• Pregnant patients
• Patients who do not self-identify as Hispanic
• Patients with known allergy to the medication
• Patients with contraindications for the prescribed medications

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

Oncological Hospital

San Juan, PR, 00935, Puerto Rico

Location

Related Publications (20)

• Abdullah S, Ahmad AA, Lalonde D. Wide Awake Local Anesthesia No Tourniquet Forearm Triple Tendon Transfer in Radial Nerve Palsy. Plast Reconstr Surg Glob Open. 2020 Aug 11;8(8):e3023. doi: 10.1097/GOX.0000000000003023. eCollection 2020 Aug.

  PMID: 32983779 BACKGROUND

• Burn MB, Shapiro LM, Eppler SL, Behal R, Kamal RN. Clinical Care Redesign to Improve Value for Trigger Finger Release: A Before-and-After Quality Improvement Study. Hand (N Y). 2021 Sep;16(5):624-631. doi: 10.1177/1558944719884661. Epub 2019 Nov 5.

  PMID: 31690136 BACKGROUND

• Lalonde D, Bell M, Benoit P, Sparkes G, Denkler K, Chang P. A multicenter prospective study of 3,110 consecutive cases of elective epinephrine use in the fingers and hand: the Dalhousie Project clinical phase. J Hand Surg Am. 2005 Sep;30(5):1061-7. doi: 10.1016/j.jhsa.2005.05.006.

  PMID: 16182068 BACKGROUND

• Chowdhry S, Seidenstricker L, Cooney DS, Hazani R, Wilhelmi BJ. Do not use epinephrine in digital blocks: myth or truth? Part II. A retrospective review of 1111 cases. Plast Reconstr Surg. 2010 Dec;126(6):2031-2034. doi: 10.1097/PRS.0b013e3181f44486.

  PMID: 20697319 BACKGROUND

• Sawhney A, Thacoor A, Nagra R, Geoghegan L, Akhavani M. Wide Awake Local Anesthetic No Tourniquet in Hand and Wrist Surgery: Current Concepts, Indications, and Considerations. Plast Reconstr Surg Glob Open. 2024 Jan 22;12(1):e5526. doi: 10.1097/GOX.0000000000005526. eCollection 2024 Jan.

  PMID: 38260757 BACKGROUND

• Deutsch CJ, Jones K, Dassayanake S, Milroy C. Concern about ischaemia drives a persistent and generation-spanning aversion to adrenaline in digital anaesthesia. JPRAS Open. 2021 Jan 26;28:61-63. doi: 10.1016/j.jpra.2021.01.006. eCollection 2021 Jun. No abstract available.

  PMID: 33732855 BACKGROUND

• Fillingham YA, Hannon CP, Erens GA; AAHKS Anesthesia & Analgesia Clinical Practice Guideline Workgroup; Hamilton WG, Della Valle CJ. Acetaminophen in Total Joint Arthroplasty: The Clinical Practice Guidelines of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. J Arthroplasty. 2020 Oct;35(10):2697-2699. doi: 10.1016/j.arth.2020.05.030. Epub 2020 May 26. No abstract available.

  PMID: 32571591 BACKGROUND

• Padilla JA, Gabor JA, Schwarzkopf R, Davidovitch RI. A Novel Opioid-Sparing Pain Management Protocol Following Total Hip Arthroplasty: Effects on Opioid Consumption, Pain Severity, and Patient-Reported Outcomes. J Arthroplasty. 2019 Nov;34(11):2669-2675. doi: 10.1016/j.arth.2019.06.038. Epub 2019 Jun 26.

  PMID: 31311667 BACKGROUND

• Gimbel JS, Brugger A, Zhao W, Verburg KM, Geis GS. Efficacy and tolerability of celecoxib versus hydrocodone/acetaminophen in the treatment of pain after ambulatory orthopedic surgery in adults. Clin Ther. 2001 Feb;23(2):228-41. doi: 10.1016/s0149-2918(01)80005-9.

  PMID: 11293556 BACKGROUND

• Thompson KA, Klein D, Alaia MJ, Strauss EJ, Jazrawi LM, Campbell KA. Opioid Use Is Reduced in Patients Treated with NSAIDs After Arthroscopic Bankart Repair: A Randomized Controlled Study. Arthrosc Sports Med Rehabil. 2020 Dec 27;3(1):e15-e22. doi: 10.1016/j.asmr.2020.08.003. eCollection 2021 Feb.

  PMID: 33615243 BACKGROUND

• Hess-Arcelay H, Claudio-Marcano A, Torres-Lugo NJ, Deliz-Jimenez D, Acosta-Julbe J, Hernandez G, Deliz-Jimenez D, Monge G, Ramirez N, Lojo-Sojo L. Opioid-Sparing Nonsteroid Anti-inflammatory Drugs Protocol in Patients Undergoing Intramedullary Nailing of Tibial Shaft Fractures: A Randomized Control Trial. J Am Acad Orthop Surg. 2024 Jun 15;32(12):e596-e604. doi: 10.5435/JAAOS-D-23-01014. Epub 2024 Apr 4.

  PMID: 38579315 BACKGROUND

• American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.

  PMID: 22227789 BACKGROUND

• Chung F, Ritchie E, Su J. Postoperative pain in ambulatory surgery. Anesth Analg. 1997 Oct;85(4):808-16. doi: 10.1097/00000539-199710000-00017.

  PMID: 9322460 BACKGROUND

• Pasero C, McCaffery M. Orthopaedic postoperative pain management. J Perianesth Nurs. 2007 Jun;22(3):160-72; quiz 172-3. doi: 10.1016/j.jopan.2007.02.004.

  PMID: 17543801 BACKGROUND

• Trasolini NA, McKnight BM, Dorr LD. The Opioid Crisis and the Orthopedic Surgeon. J Arthroplasty. 2018 Nov;33(11):3379-3382.e1. doi: 10.1016/j.arth.2018.07.002. Epub 2018 Jul 11.

  PMID: 30075877 BACKGROUND

• Harris JD. Management of expected and unexpected opioid-related side effects. Clin J Pain. 2008 May;24 Suppl 10:S8-S13. doi: 10.1097/AJP.0b013e31816b58eb.

  PMID: 18418226 BACKGROUND

• Huynh MNQ, Yuan M, Gallo L, Olaiya OR, Barkho J, McRae M. Opioid Consumption After Upper Extremity Surgery: A Systematic Review. Hand (N Y). 2024 Sep;19(6):1002-1011. doi: 10.1177/15589447231160211. Epub 2023 Mar 23.

  PMID: 36960481 BACKGROUND

• Feinberg AE, Chesney TR, Srikandarajah S, Acuna SA, McLeod RS; Best Practice in Surgery Group. Opioid Use After Discharge in Postoperative Patients: A Systematic Review. Ann Surg. 2018 Jun;267(6):1056-1062. doi: 10.1097/SLA.0000000000002591.

  PMID: 29215370 BACKGROUND

• Fader L, Whitaker J, Lopez M, Vivace B, Parra M, Carlson J, Zamora R. Tibia fractures and NSAIDs. Does it make a difference? A multicenter retrospective study. Injury. 2018 Dec;49(12):2290-2294. doi: 10.1016/j.injury.2018.09.024. Epub 2018 Sep 18.

  PMID: 30270011 BACKGROUND

• Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012 Apr;37(4):645-50. doi: 10.1016/j.jhsa.2012.01.035. Epub 2012 Mar 10.

  PMID: 22410178 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Oxycodone; Acetaminophen; Naproxen; Tablets

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Naphthaleneacetic Acids; Naphthalenes; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Christian A. Foy, MD

  University of Puerto Rico Medical Sciences Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose I Acosta Julbe, MD

CONTACT

+1 7873794119; jose.acosta14@upr.edu

Daniel E. Deliz Jiménez, BSc

CONTACT

+1 7872332369; daniel.deliz@upr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Christian A. Foy

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)