Postoperative PainPhase 1/2Dex-Dex PNBNCT07099222
Efficacy of Non-weight Based, Low Dose Dex-Dex Adjuncts in Prolonging Peripheral Nerve Blocks
A Phase 1/2 study testing Low, non-weight based dose of Dexamethasone and Dexmedetomidine in peripheral nerve blocks and Ropivacaine with low, non weight based Dexamethasone additive in people with Postoperative Pain and Nausea and Vomiting, Postoperative, run by University of Arizona at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Nausea and Vomiting, Postoperative, Dizziness
- What is being tested?
- Low, non-weight based dose of Dexamethasone and Dexmedetomidine in peripheral nerve blocks and Ropivacaine with low, non weight based Dexamethasone additive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2024to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner - University Medical Center South
Tucson, Arizona, 85713
About this study
Official title: Extended Duration of Peripheral Nerve Blocks With Low, Non-weight-based Adjuncts of Dexamethasone and Dexmedetomidine Compared to Dexamethasone Alone in Orthopedic Surgery: A Prospective, Single-blind, Randomized Controlled Trial
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.
Read the detailed description
The standard practice for anesthesia in non-weight-bearing orthopedic foot and ankle surgery is to offer the patient popliteal (sciatic nerve) and saphenous (distal branch of femoral nerve) peripheral nerve blocks for postoperative pain control to minimize opioid requirements. Similarly, supraclavicular nerve blocks that decrease painful stimuli transmission through the brachial plexus are offered to patients undergoing shoulder joint procedures. For these peripheral nerve blocks, it is routine to use dexamethasone (glucocorticoid) as an additive in the local anesthetic injection which can prolong the local anesthetic effect of the blocks by 4-8 hours with minimal side effects observed and no dose-response relationship with perineural injection doses of 4, 8, 10, and 12mg. Though the precise mechanism of action has not been fully understood, it is largely believed that perineural injection of dexamethasone increases the effects of local anesthetics at least in part due to vasoconstriction.
Current literature suggests that 1-2 mcg/kg of dexmedetomidine will also prolong the peripheral nerve blocks but consistent utilization thus far has been limited by side-effects of higher, more efficacious doses. The potential dose-dependent side effects associated with the use of perineural dexmedetomidine include bradycardia, hypotension, and excessive sedation. There are minimal to no side-effects observed when perineural dexmedetomidine doses are kept below 1 mcg/kg. However, its effects on prolonging nerve blocks are not significant until the dose is increased to 1.5 mcg/kg where the nerve block is extended roughly 4-8 hours, similar to using dexamethasone as an adjunct. At doses greater than 2 mcg/kg, however, the nerve block can last up to 2-3 days but at the tradeoff of increased perioperative bradycardia and hypotension from presumed systemic absorption and dexmedetomidine's highly selective α2 agonist effects. Another study showed that when a low, non-weight-based dose of 50 mcg of dexmedetomidine was used in adults weighing over 50 kg, the duration of analgesia was improved, but its effects were less than 8 mg of dexamethasone as an adjunct, and the improvement of the duration of blockade at this low dose of dexmedetomidine was not significant. When both dexamethasone and dexmedetomidine were utilized as intravenous adjuncts administered at the time of performing the nerve blocks instead of in the perineural injection, Maagaard et al. discovered that dexamethasone improved the duration of analgesia of popliteal and saphenous nerve blocks in patients undergoing foot and ankle surgeries with or without dexmedetomidine. These findings support the theory that dexmedetomidine's local effects at the site of the injection, as opposed to its systemic analgesic effects on α2 receptors in the central nervous system, may be predominantly responsible for its role as an adjunct in prolonging the effects of local anesthetics in peripheral nerve blocks. The theory is also supported by Brummett et al and their findings that the analgesic effects of dexmedetomidine as an adjunct could not be reversed by an α2 receptor antagonist given systemically.
This study aims to determine a safe and effective approach for using dexamethasone and dexmedetomidine in combination using low, non-weight based (NWB) doses of both adjuncts. The researchers plan to track the duration of the blocks for 7 days postoperatively as well as any unwanted side effects in the post-anesthesia care unit including: hypotension, bradycardia, oversedation, and respiratory depression. The research team will contact subjects by email and rely on daily participant surveys (REDCap Survey POD #0) submitted electronically to provide subjective feedback on block duration and postoperative pain for 7 days using the PROMIS pain scale within the survey. Participants will also report pain medication usage for the same time frame including both opioid and non-opioid medications. Side effects in the post anesthesia care unit (PACU) will be documented by PACU nurses using the POSS sedation scale and comparing vital signs such as heart rate and blood pressure at 15- and 30-minute intervals to pre-operation recordings. Subjects might receive a phone call reminder to complete the daily surveys after their surgery, or if the research team notices that they have not completed the surveys on time.
Preliminary data has been very promising. The investigator's facility has thus far declined the use of liposomal bupivacaine, which has limited the ability to offer the patients peripheral nerve blocks lasting greater than 24 hours. Therefore, to extend the length of our peripheral nerve blocks the research team added both 4 mg dexamethasone and 50 mcg dexmedetomidine to 30 ml of 0.5% ropivacaine for lower extremity blocks for patients that would benefit from a prolonged nerve block for postoperative pain. The roughly 31.5 ml solution is then split evenly between the popliteal and saphenous nerve blocks. The investigators observed that these blocks frequently extended the duration of the block to 2-5 days compared to the standard 20-24 hours normally observed with dexamethasone adjunct alone. Similarly, the exact same additives (4 mg dexamethasone and 50 mcg dexmedetomidine) have been added to 15 ml of 0.5% Ropivacaine for shoulder procedures with similar observations noted of increased duration. This posed a research question that the investigators wishe to investigate further that compares their usual practice of blocks with ropivacaine and dexamethasone alone to blocks utilizing both dexamethasone and dexmedetomidine as adjuncts. The investigators chose the dexmedetomidine dose in combination with their inclusion criteria of adults weighing more than 50 kg so that the patients in this study will not receive a dexmedetomidine adjunct dose that is greater than 1 mcg/kg.
For the initial research the investigators plan on recruiting patients who are undergoing foot and ankle surgery who are not expected to participate in weight-bearing physical rehabilitation immediately after surgery and that would benefit from a potential multi-day nerve block for primary pain management. The investigators also plan on recruiting patients undergoing extensive shoulder surgery such as total shoulder arthroplasty and rotator cuff repairs because these procedures tend to have higher observed post-operative pain associated and the patients are not expected to participate in active rehabilitation immediately after surgery.
- Conditions
- Postoperative Pain, Nausea and Vomiting, Postoperative, Dizziness, Constipation, Duration of Response, Narcotics Consumption
- Being tested
- Low, non-weight based dose of Dexamethasone and Dexmedetomidine in peripheral nerve blocks, Ropivacaine with low, non weight based Dexamethasone additive
- 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
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Dizziness, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low, non-weight based dose of Dexamethasone and Dexmedetomidine in peripheral nerve blocksDrug
Also called Dexamethasone and Dexmedetomidine
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.
Ropivacaine with low, non weight based Dexamethasone additiveDrug
Also called Ropivacaine and Dexamethasone
Very accepted, standard peripheral nerve block with steroid adjunct solution used to increase the duration of local anesthetic by 4-6hrs.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: nerve blocks containing Ropivacaine and Dexamethasone only | Experimental | Ropivicaine peripheral nerve block solution with 4mg Dexamethasone adjunct Receives: 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 Receives: Drug: Low, non-weight based dose of Dexamethasone and Dexmedetomidine in peripheral nerve blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Nerve Block Duration
Using automated daily emailed patient surveys to assess for the duration of the peripheral nerve block.
Measured: 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.
Measured: 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
Measured: 0-7 days
Secondary outcomes (1)
Post-opertive side effects
Measuring any reduction in opioid use side effects in the study group as a result of increased block duration leading to less opioid use for breakthrough pain. These side effects measured include: nausea, vomiting, lightheadedness, dizziness, and constipation.
Measured: 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start10 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Tang, University of Arizona
- Investigators
- Ronald Tang, MD, Principal investigator, University of Arizona - Banner Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099222
- Sponsor's protocol ID
- 00004763
- Acronym
- Dex-Dex PNB
- Status last verified
- Nov 2025
- First submitted
- 25 Jul 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical researchers may contact the principal investigator (Ronald Tang, MD) to request the raw data for the study. All shared data will be void of personal identifiers. Sharing of data will be granted on a case by case basis determined by the credentials of the requesting researcher and necessity for requesting the data.
Publications
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.
PubMed 29121400Andersen 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.
PubMed 34811722Chen 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.
PubMed 37220544Singh 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.
PubMed 33013041Venkatraman 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.
PubMed 34103832Maagaard 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.
PubMed 38489226Brummett 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.
PubMed 20814283Desai 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.
PubMed 33456903Obayah 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.
PubMed 19935071Iyengar 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.
PubMed 37575723Schubert 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.
PubMed 37337656Wei 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.
PubMed 37396910Edinoff 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.
PubMed 34540647Brummett 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.
PubMed 21666435Marhofer 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.
PubMed 27258154
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Duration of Peripheral Nerve Blocks With Low, Non-weight-based Adjuncts of Dexamethasone and Dexmedetomidine Compared to Dexamethasone Alone in Orthopedic Surgery: A Prospective, Single-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07099222
- Acronym / sponsor ID
- Dex-Dex PNB / 00004763
- Conditions
- Postoperative Pain, Nausea and Vomiting, Postoperative, Dizziness, Constipation, Duration of Response, Narcotics Consumption
- Keywords
- Peripheral nerve block, PNB, Dex-Dex, Adjuncts, Dexmedetomidine, Dexamethasone, Extended Nerve Block, Additive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The standard practice for anesthesia in non-weight-bearing orthopedic foot and ankle surgery is to offer the patient popliteal (sciatic nerve) and saphenous (distal branch of femoral nerve) peripheral nerve blocks for postoperative pain control to minimize opioid requirements. Similarly, supraclavicular nerve blocks that decrease painful stimuli transmission through the brachial plexus are offered to patients undergoing shoulder joint procedures. For these peripheral nerve blocks, it is routine to use dexamethasone (glucocorticoid) as an additive in the local anesthetic injection which can prolong the local anesthetic effect of the blocks by 4-8 hours with minimal side effects observed and no dose-response relationship with perineural injection doses of 4, 8, 10, and 12mg. Though the precise mechanism of action has not been fully understood, it is largely believed that perineural injection of dexamethasone increases the effects of local anesthetics at least in part due to vasoconstriction.
Current literature suggests that 1-2 mcg/kg of dexmedetomidine will also prolong the peripheral nerve blocks but consistent utilization thus far has been limited by side-effects of higher, more efficacious doses. The potential dose-dependent side effects associated with the use of perineural dexmedetomidine include bradycardia, hypotension, and excessive sedation. There are minimal to no side-effects observed when perineural dexmedetomidine doses are kept below 1 mcg/kg. However, its effects on prolonging nerve blocks are not significant until the dose is increased to 1.5 mcg/kg where the nerve block is extended roughly 4-8 hours, similar to using dexamethasone as an adjunct. At doses greater than 2 mcg/kg, however, the nerve block can last up to 2-3 days but at the tradeoff of increased perioperative bradycardia and hypotension from presumed systemic absorption and dexmedetomidine's highly selective α2 agonist effects. Another study showed that when a low, non-weight-based dose of 50 mcg of dexmedetomidine was used in adults weighing over 50 kg, the duration of analgesia was improved, but its effects were less than 8 mg of dexamethasone as an adjunct, and the improvement of the duration of blockade at this low dose of dexmedetomidine was not significant. When both dexamethasone and dexmedetomidine were utilized as intravenous adjuncts administered at the time of performing the nerve blocks instead of in the perineural injection, Maagaard et al. discovered that dexamethasone improved the duration of analgesia of popliteal and saphenous nerve blocks in patients undergoing foot and ankle surgeries with or without dexmedetomidine. These findings support the theory that dexmedetomidine's local effects at the site of the injection, as opposed to its systemic analgesic effects on α2 receptors in the central nervous system, may be predominantly responsible for its role as an adjunct in prolonging the effects of local anesthetics in peripheral nerve blocks. The theory is also supported by Brummett et al and their findings that the analgesic effects of dexmedetomidine as an adjunct could not be reversed by an α2 receptor antagonist given systemically.
This study aims to determine a safe and effective approach for using dexamethasone and dexmedetomidine in combination using low, non-weight based (NWB) doses of both adjuncts. The researchers plan to track the duration of the blocks for 7 days postoperatively as well as any unwanted side effects in the post-anesthesia care unit including: hypotension, bradycardia, oversedation, and respiratory depression. The research team will contact subjects by email and rely on daily participant surveys (REDCap Survey POD #0) submitted electronically to provide subjective feedback on block duration and postoperative pain for 7 days using the PROMIS pain scale within the survey. Participants will also report pain medication usage for the same time frame including both opioid and non-opioid medications. Side effects in the post anesthesia care unit (PACU) will be documented by PACU nurses using the POSS sedation scale and comparing vital signs such as heart rate and blood pressure at 15- and 30-minute intervals to pre-operation recordings. Subjects might receive a phone call reminder to complete the daily surveys after their surgery, or if the research team notices that they have not completed the surveys on time.
Preliminary data has been very promising. The investigator's facility has thus far declined the use of liposomal bupivacaine, which has limited the ability to offer the patients peripheral nerve blocks lasting greater than 24 hours. Therefore, to extend the length of our peripheral nerve blocks the research team added both 4 mg dexamethasone and 50 mcg dexmedetomidine to 30 ml of 0.5% ropivacaine for lower extremity blocks for patients that would benefit from a prolonged nerve block for postoperative pain. The roughly 31.5 ml solution is then split evenly between the popliteal and saphenous nerve blocks. The investigators observed that these blocks frequently extended the duration of the block to 2-5 days compared to the standard 20-24 hours normally observed with dexamethasone adjunct alone. Similarly, the exact same additives (4 mg dexamethasone and 50 mcg dexmedetomidine) have been added to 15 ml of 0.5% Ropivacaine for shoulder procedures with similar observations noted of increased duration. This posed a research question that the investigators wishe to investigate further that compares their usual practice of blocks with ropivacaine and dexamethasone alone to blocks utilizing both dexamethasone and dexmedetomidine as adjuncts. The investigators chose the dexmedetomidine dose in combination with their inclusion criteria of adults weighing more than 50 kg so that the patients in this study will not receive a dexmedetomidine adjunct dose that is greater than 1 mcg/kg.
For the initial research the investigators plan on recruiting patients who are undergoing foot and ankle surgery who are not expected to participate in weight-bearing physical rehabilitation immediately after surgery and that would benefit from a potential multi-day nerve block for primary pain management. The investigators also plan on recruiting patients undergoing extensive shoulder surgery such as total shoulder arthroplasty and rotator cuff repairs because these procedures tend to have higher observed post-operative pain associated and the patients are not expected to participate in active rehabilitation immediately after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group: nerve blocks containing Ropivacaine and Dexamethasone only | Experimental | Drug: Ropivacaine with low, non weight based Dexamethasone additiveRopivicaine peripheral nerve block solution with 4mg Dexamethasone adjunct |
| Study Group: nerve blocks containing Ropivacaine, Dexamethasone, and Dexmedetomidine | Experimental | Drug: Low, non-weight based dose of Dexamethasone and Dexmedetomidine in peripheral nerve blocksRopivacaine local anesthetic solution with 4mg Dexamethasone AND 25mcg Dexmedetomidine added |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low, non-weight based dose of Dexamethasone and Dexmedetomidine in peripheral nerve blocksAlso: Dexamethasone and DexmedetomidineLow, 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. | Drug | Study Group: nerve blocks containing Ropivacaine, Dexamethasone, and Dexmedetomidine |
| Ropivacaine with low, non weight based Dexamethasone additiveAlso: Ropivacaine and DexamethasoneVery accepted, standard peripheral nerve block with steroid adjunct solution used to increase the duration of local anesthetic by 4-6hrs. | Drug | Control Group: nerve blocks containing Ropivacaine and Dexamethasone only |
Primary outcome
Peripheral Nerve Block Duration
Time frame: 0-7 days
Using automated daily emailed patient surveys to assess for the duration of the peripheral nerve block.
Post-operative pain scores
Time frame: 0-7 days
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.
Pain medicine (opioid and non-opioid) consumption post-operatively
Time frame: 0-7 days
Opioid and non-opioid pain medication consumption postoperatively, reported daily by the participant for 7 days
1 secondary outcome
Post-opertive side effects
Time frame: 0-7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 29121400Pehora 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.
- Background: PubMed 34811722Andersen 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.
- Background: PubMed 37220544Chen 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.
- Background: PubMed 33013041Singh 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.
- Background: PubMed 34103832Venkatraman 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.
- Background: PubMed 38489226Maagaard 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.
- Background: PubMed 20814283Brummett 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.
- Background: PubMed 33456903Desai 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.
- Background: PubMed 19935071Obayah 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.
- Background: PubMed 37575723Iyengar 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.
- Background: PubMed 37337656Schubert 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.
- Background: PubMed 37396910Wei 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.
- Individual participant dataSharing planned: Yes. Clinical researchers may contact the principal investigator (Ronald Tang, MD) to request the raw data for the study. All shared data will be void of personal identifiers. Sharing of data will be granted on a case by case basis determined by the credentials of the requesting researcher and necessity for requesting the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Tang, MD principal investigator
University of Arizona - Banner Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low, non-weight based dose of Dexamethasone and Dexmedetomidine in peripheral nerve blocks and Ropivacaine with low, non weight based Dexamethasone additive in people with Postoperative Pain and Nausea and Vomiting, Postoperative, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Nerve Block Duration (time frame: 0-7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07099222, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.