Efficacy of Non-weight Based, Low Dose Dex-Dex Adjuncts in Prolonging Peripheral Nerve Blocks

NCT07099222 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 00004763
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to improve upon the standard practice of utilizing nerve blocks to enhance the satisfaction of patients undergoing shoulder, or foot and ankle surgery regarding their quality of pain control, the duration of their nerve blocks, as well as the avoidance of opioid medications and subsequently their undesirable side effects. The researchers hypothesize that dexmedetomidine and dexamethasone (Dex-Dex) will work synergistically as adjuncts in a low, non-weight based formula. This would allow the investigators to improve patient satisfaction by providing them with a superior means of pain control that is longer in duration with a decreased probability of unwanted side effects. The proposed clinical study will be a prospective, randomized control trial.

Conditions

Postoperative Pain; Nausea and Vomiting, Postoperative; Dizziness; Constipation; Duration of Response; Narcotics Consumption; Pain After Surgery

Keywords

Peripheral nerve block; PNB; Dex-Dex; Adjuncts; Dexmedetomidine; Dexamethasone; Extended Nerve Block; Additive; Prolonged Nerve Block; Dex; Steroid; Precedex; Decadron; Brachial Plexus; Sciatic; Femoral; Popliteal; Saphenous; Adductor Canal

Outcome Measures

Primary Outcomes (3)

• Peripheral Nerve Block Duration

  Using automated daily emailed patient surveys to assess for the duration of the peripheral nerve block.

  0-7 days

• Post-operative pain scores

  Postoperative pain scores based on the Patient-Reported Outcomes Measurement Information System (PROMIS) numeric rating scale for pain intensity with response scores from 0 (no pain) to 10 (pain as bad as it can be) are to be reported daily by the participant for 7 days after surgery. Therefore, a higher score on the scale would indicate a worse outcome in terms of pain experienced by the participant.

  0-7 days

• Pain medicine (opioid and non-opioid) consumption post-operatively

  Opioid and non-opioid pain medication consumption postoperatively, reported daily by the participant for 7 days

  0-7 days

Secondary Outcomes (1)

• Post-opertive side effects

  0-7 days

Study Arms (2)

Control Group: nerve blocks containing Ropivacaine and Dexamethasone only

EXPERIMENTAL

Ropivicaine peripheral nerve block solution with 4mg Dexamethasone adjunct

Drug: Ropivacaine with low, non weight based Dexamethasone additive

Study Group: nerve blocks containing Ropivacaine, Dexamethasone, and Dexmedetomidine

EXPERIMENTAL

Ropivacaine local anesthetic solution with 4mg Dexamethasone AND 25mcg Dexmedetomidine added

Drug: Low, non-weight based dose of Dexamethasone and Dexmedetomidine in peripheral nerve blocks

Interventions

Ropivacaine with low, non weight based Dexamethasone additive DRUG

Very accepted, standard peripheral nerve block with steroid adjunct solution used to increase the duration of local anesthetic by 4-6hrs.

Also known as: Ropivacaine and Dexamethasone

Control Group: nerve blocks containing Ropivacaine and Dexamethasone only

Low, non-weight based dose of Dexamethasone and Dexmedetomidine in peripheral nerve blocks DRUG

Low, non-weight based dose of Dexamethasone and Dexmedetomidine adjunct with Ropivacaine (local anesthetic) for use in peripheral nerve blocks to look for synergistic effects of the combination in extending the duration of the block while limiting any potential side effects of each additive.

Also known as: Dexamethasone and Dexmedetomidine

Study Group: nerve blocks containing Ropivacaine, Dexamethasone, and Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults (18 years and older but less than 75)
• Speaks and understands English.
• Capable of performing all activities of daily living independently
• Normal development for age and without cognitive impairment
• Weight over 50 kg
• Undergoing scheduled, elective foot, ankle, and shoulder surgery
• Patient is not expected to perform weight-bearing rehabilitation post-op for 1 week.
• Regular access to the internet

You may not qualify if:

• Under 18 or older than 75 years of age
• Pregnancy
• Known allergy to local anesthetics including lidocaine and ropivacaine.
• Known allergy to glucocorticoid steroids or necessary abstinence for medical reasons.
• Known allergy to dexmedetomidine or other α2 agonist derivatives.
• Severe organ dysfunction: end-stage renal disease, liver failure
• Severe psychiatric disease that alters sense of reality and interferes with pain perception.
• Severe cognitive impairment that interferes with pain perception
• Chronic opioid use, alcohol abuse, or any other substance abuse
• Urgent/emergent procedure
• Emergency return to OR after initial surgery
• Infection at block or surgical site
• Hemodynamic instability preoperatively
• Hemodynamic instability during surgery affects timely extubating at the end of surgery.
• Failed nerve blocks that did not end up blocking the nerves as intended, or inadequate nerve blocks requiring repeat rescue blocks in PACU.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner - University Medical Center South

Tucson, Arizona, 85713, United States

Location

Related Publications (18)

• Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2.

  PMID: 29121400 BACKGROUND

• Andersen JH, Karlsen A, Geisler A, Jaeger P, Grevstad U, Dahl JB, Mathiesen O. Alpha2 -receptor agonists as adjuvants for brachial plexus nerve blocks-A systematic review with meta-analyses. Acta Anaesthesiol Scand. 2022 Feb;66(2):186-206. doi: 10.1111/aas.14002. Epub 2021 Dec 21.

  PMID: 34811722 BACKGROUND

• Chen Z, Liu Z, Feng C, Jin Y, Zhao X. Dexmedetomidine as an Adjuvant in Peripheral Nerve Block. Drug Des Devel Ther. 2023 May 17;17:1463-1484. doi: 10.2147/DDDT.S405294. eCollection 2023.

  PMID: 37220544 BACKGROUND

• Singh N, Gupta S, Kathuria S. Dexmedetomidine vs dexamethasone as an adjuvant to 0.5% ropivacaine in ultrasound-guided supraclavicular brachial plexus block. J Anaesthesiol Clin Pharmacol. 2020 Apr-Jun;36(2):238-243. doi: 10.4103/joacp.JOACP_176_19. Epub 2020 Jun 15.

  PMID: 33013041 BACKGROUND

• Venkatraman R, Pushparani A, Karthik K, Nandhini P. Comparison of morphine, dexmedetomidine and dexamethasone as an adjuvant to ropivacaine in ultrasound-guided supraclavicular brachial plexus block for postoperative analgesia-a randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2021 Jan-Mar;37(1):102-107. doi: 10.4103/joacp.JOACP_70_19. Epub 2021 Apr 10.

  PMID: 34103832 BACKGROUND

• Maagaard M, Funder KS, Schou NK, Penny JO, Toquer P, Laigaard J, Stormholt ER, Norskov AK, Jaeger P, Andersen JH, Mathiesen O. Combined Dexamethasone and Dexmedetomidine as Adjuncts to Popliteal and Saphenous Nerve Blocks in Patients Undergoing Surgery of the Foot or Ankle: A Randomized, Blinded, Placebo-controlled Clinical Trial. Anesthesiology. 2024 Jun 1;140(6):1165-1175. doi: 10.1097/ALN.0000000000004977.

  PMID: 38489226 BACKGROUND

• Brummett CM, Amodeo FS, Janda AM, Padda AK, Lydic R. Perineural dexmedetomidine provides an increased duration of analgesia to a thermal stimulus when compared with a systemic control in a rat sciatic nerve block. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):427-31. doi: 10.1097/AAP.0b013e3181ef4cf0.

  PMID: 20814283 BACKGROUND

• Desai N, Albrecht E, El-Boghdadly K. Perineural adjuncts for peripheral nerve block. BJA Educ. 2019 Sep;19(9):276-282. doi: 10.1016/j.bjae.2019.05.001. Epub 2019 Jul 6. No abstract available.

  PMID: 33456903 BACKGROUND

• Obayah GM, Refaie A, Aboushanab O, Ibraheem N, Abdelazees M. Addition of dexmedetomidine to bupivacaine for greater palatine nerve block prolongs postoperative analgesia after cleft palate repair. Eur J Anaesthesiol. 2010 Mar;27(3):280-4. doi: 10.1097/EJA.0b013e3283347c15.

  PMID: 19935071 BACKGROUND

• Iyengar SS, Pangotra A, Abhishek K, Sinha N, Rao NS, Singh VK, Prakash J. The Comparison of Dexmedetomidine to Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Infraclavicular Brachial Plexus Block in Upper Limb Surgeries. Cureus. 2023 Jul 10;15(7):e41668. doi: 10.7759/cureus.41668. eCollection 2023 Jul.

  PMID: 37575723 BACKGROUND

• Schubert AK, Seneviratne V, Stolz J, Wiesmann T, Wulf H, Eberhart L, Dinges HC. The effect of adjuvants added to local anaesthetics for single-injection upper extremity peripheral regional anaesthesia: A systematic review with network meta-analysis of randomised trials. Eur J Anaesthesiol. 2023 Sep 1;40(9):672-690. doi: 10.1097/EJA.0000000000001860. Epub 2023 Jun 19.

  PMID: 37337656 BACKGROUND

• Wei XM, Liu Z, Lv LC, Wu GH, Sun PY, Gu CP, Shi PC. Comparison of dexmedetomidine and dexamethasone as adjuvants to the ultrasound-guided interscalene nerve block in arthroscopic shoulder surgery: a systematic review and Bayesian network meta-analysis of randomized controlled trials. Front Med (Lausanne). 2023 Jun 16;10:1159216. doi: 10.3389/fmed.2023.1159216. eCollection 2023.

  PMID: 37396910 BACKGROUND

• Edinoff AN, Houk GM, Patil S, Bangalore Siddaiah H, Kaye AJ, Iyengar PS, Cornett EM, Imani F, Mahmoudi K, Kaye AM, Urman RD, Kaye AD. Adjuvant Drugs for Peripheral Nerve Blocks: The Role of Alpha-2 Agonists, Dexamethasone, Midazolam, and Non-steroidal Anti-inflammatory Drugs. Anesth Pain Med. 2021 Jul 4;11(3):e117197. doi: 10.5812/aapm.117197. eCollection 2021 Jun.

  PMID: 34540647 BACKGROUND

• Brummett CM, Hong EK, Janda AM, Amodeo FS, Lydic R. Perineural dexmedetomidine added to ropivacaine for sciatic nerve block in rats prolongs the duration of analgesia by blocking the hyperpolarization-activated cation current. Anesthesiology. 2011 Oct;115(4):836-43. doi: 10.1097/ALN.0b013e318221fcc9.

  PMID: 21666435 BACKGROUND

• Marhofer P, Brummett CM. Safety and efficiency of dexmedetomidine as adjuvant to local anesthetics. Curr Opin Anaesthesiol. 2016 Oct;29(5):632-7. doi: 10.1097/ACO.0000000000000364.

  PMID: 27258154 BACKGROUND

• Chen BS, Peng H, Wu SN. Dexmedetomidine, an alpha2-adrenergic agonist, inhibits neuronal delayed-rectifier potassium current and sodium current. Br J Anaesth. 2009 Aug;103(2):244-54. doi: 10.1093/bja/aep107. Epub 2009 Jun 20.

  PMID: 19542547 BACKGROUND

• Reddy BS, Gaude YK, Vaidya S, Kini GK, Budania LS, Eeshwar MV. Effect of dexmedetomidine on characteristics of ultrasound-guided supraclavicular brachial plexus block with levobupivacaine-A prospective double-blind randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2021 Jul-Sep;37(3):371-377. doi: 10.4103/joacp.JOACP_289_18. Epub 2021 Oct 12.

  PMID: 34759546 BACKGROUND

• Jung HS, Seo KH, Kang JH, Jeong JY, Kim YS, Han NR. Optimal dose of perineural dexmedetomidine for interscalene brachial plexus block to control postoperative pain in patients undergoing arthroscopic shoulder surgery: A prospective, double-blind, randomized controlled study. Medicine (Baltimore). 2018 Apr;97(16):e0440. doi: 10.1097/MD.0000000000010440.

  PMID: 29668608 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Dizziness; Constipation

Interventions

Dexmedetomidine; Dexamethasone; Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Sensation Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ronald Tang, MD

  University of Arizona - Banner Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: There will be a control group and a study group. A pre-determined order will be made for assignment into groups. There will be a separate predetermined randomization for patients undergoing shoulder surgery and patients undergoing foot/ankle surgery to help evenly distribute the number of participants assigned to the control and study groups in each subset. The control groups for both shoulder and foot/ankle surgery will receive Ropivacaine with Dexamethasone injection for their peripheral nerve block(s) in the same concentration. The study groups will receive nerve blocks containing Ropivacaine with Dexamethasone and Dexmedetomidine in the same concentration.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: October 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 3 years after the publication of results.
• Access Criteria: Researchers studying the effects of Dexmedetomidine and Dexamethasone may request access to the IPD and supporting information. The principal investigator will ultimately decide if criteria is met for data to be shared. In addition, a data sharing agreement may need to be signed on accordance with the University of Arizona and Banner University Medical Center policies.

Locations

US (1)