Ankle DiseaseNCT07289620
Dexamethasone vs Dexmedetomidine vs Combination as Adjuvants to Popliteal Sciatic Nerve Block in Children
A study testing Dexamethasone, Dexmedetomidine and Dexamethasone + Dexmedetomidine in people with Ankle Disease and Foot Diseases, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
This clinical study will evaluate three commonly used medications that can be added to local anesthetic during a popliteal sciatic nerve block in children undergoing surgery of the lower leg or foot. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Ankle Disease, Foot Diseases
- What is being tested?
- Dexamethasone, Dexmedetomidine and Dexamethasone + Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 16 Jan 2026to 31 Jan 2027
- Phase
- Interventional
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 12 years.
- Scheduled for elective unilateral lower limb surgery (foot, ankle, or distal lower leg) under general anesthesia with a popliteal sciatic nerve block planned for postoperative analgesia.
- ASA physical status I-III.
- Ability of parents or legal guardians to understand the study procedures and provide written informed consent.
- Child and parents/guardians available for telephone follow-up at 1 week and 1 month after surgery.
Who cannot join
- Refusal of the parents/legal guardians to provide informed consent or refusal of the child to cooperate with anesthesia or study procedures.
- Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any component of the study medications.
- Pre-existing neurological deficit or neuromuscular disease affecting the lower limbs (motor or sensory).
- Coagulopathy or current therapeutic anticoagulation that contraindicates regional anesthesia.
- Local infection, inflammation, or skin lesions at the planned block site.
- Severe cardiac, hepatic, renal, or respiratory disease that, in the investigator's opinion, increases the risk of study participation.
Show all 11Show fewer
- History of clinically significant arrhythmias, severe bradycardia, or second/third degree atrioventricular block not treated with a pacemaker.
- Developmental delay or severe cognitive impairment that precludes reliable pain assessment or follow-up.
- Chronic use of opioid analgesics or sedatives (≥ 2 weeks of daily use before surgery).
- Participation in another interventional clinical trial within the last 30 days.
- Any other condition considered by the investigator to interfere with protocol adherence, safety monitoring, or reliable outcome assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 62-701
Malgorzata Reysner, M.D. Ph.D., +48 61 873 83 03, mreysner@ump.edu.pl
About this study
Official title: A Randomized, Double-Blinded, Controlled Trial Comparing Perineural Dexamethasone, Dexmedetomidine, and Their Combination as Adjuvants to Ropivacaine for Popliteal Sciatic Nerve Block in Pediatric Patients
This clinical study will evaluate three commonly used medications that can be added to local anesthetic during a popliteal sciatic nerve block in children undergoing surgery of the lower leg or foot. These medications-dexamethasone, dexmedetomidine, or a combination of both-may help the nerve block last longer and provide better postoperative pain control.
All participating children will receive a standard popliteal sciatic nerve block with ropivacaine, a commonly used local anesthetic. They will then be randomly assigned to one of three groups: (1) ropivacaine with dexamethasone, (2) ropivacaine with dexmedetomidine, or (3) ropivacaine with both dexamethasone and dexmedetomidine. Neither the children, parents, nor the clinical staff assessing pain will know which medication was given.
The goal of this study is to determine whether the combination of dexamethasone and dexmedetomidine provides longer pain relief and reduces the need for additional pain medication compared with either medication alone. The results may help identify the most effective and safest strategy for improving postoperative comfort in pediatric patients receiving regional anesthesia.
Read the detailed description
Popliteal sciatic nerve block is frequently used in pediatric anesthesia to provide effective pain control for surgical procedures involving the lower leg, ankle, and foot. Although ropivacaine alone offers good analgesia, its duration is limited, and additional medications (adjuvants) are often added to prolong the effect of the block. Two commonly used adjuvants are dexamethasone, a corticosteroid, and dexmedetomidine, an alpha-2 adrenergic agonist. Each of these medications has been shown to extend the duration of analgesia, but it remains unclear whether combining them provides an additive or potentially synergistic benefit.
This randomized, double-blinded, controlled clinical trial will compare three perineural adjuvant strategies: dexamethasone, dexmedetomidine, and their combination. All participants will receive a single-shot popliteal sciatic nerve block with 0.2% ropivacaine. Children will then be randomized into one of three treatment arms:
- ropivacaine with perineural dexamethasone,
- ropivacaine with perineural dexmedetomidine, or
- ropivacaine with a perineural combination of dexamethasone and dexmedetomidine. Pain scores, block duration, opioid use, and recovery parameters will be assessed by trained observers who are blinded to group assignment. The primary aim is to determine whether the combination of dexamethasone and dexmedetomidine leads to superior analgesia compared with either drug alone. Secondary aims include evaluating the time to first rescue analgesia, total postoperative opioid requirements, behavioral pain scores (e.g., FLACC), adverse events, and early functional recovery.
This study seeks to provide high-quality evidence to guide the optimal choice of perineural adjuvants in pediatric regional anesthesia and may help establish best-practice recommendations for improving postoperative comfort and safety in children undergoing lower-limb surgery.
- Conditions
- Ankle Disease, Foot Diseases
- Being tested
- Dexamethasone, Dexmedetomidine, Dexamethasone + Dexmedetomidine
- Medical subject headings
- Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Perineural dexamethasone will be administered as an adjuvant to a single-shot popliteal sciatic nerve block. Children will receive 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg dexamethasone, injected under ultrasound guidance using a 22-gauge echogenic needle prior to surgery. The medication will be given as a single perineural dose only. Standard perioperative analgesia will be provided to all participants.
DexmedetomidineDrug
Perineural dexmedetomidine will be administered as an adjuvant to a single-shot popliteal sciatic nerve block. Children will receive 0.3 mL/kg of 0.2% ropivacaine combined with 0.5 µg/kg dexmedetomidine, injected under ultrasound guidance with a 22-gauge echogenic needle prior to surgery. The medication will be administered as a single perineural bolus. Standard perioperative analgesia will be provided to all participants.
Dexamethasone + DexmedetomidineDrug
Children in this arm will receive a combination of two perineural adjuvants added to a single-shot popliteal sciatic nerve block. The block will include 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg dexamethasone and 0.5 µg/kg dexmedetomidine, administered under ultrasound guidance using a 22-gauge echogenic needle prior to surgery. Both medications will be delivered together as a single perineural bolus. Standard perioperative analgesia will be provided to all participants.
| Study group | Role | What they receive |
|---|---|---|
| Perineural Dexamethasone | Active comparator | Children in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg perineural dexamethasone (maximum dose per institutional pediatric guidelines). The block will be performed using a 22-gauge echogenic needle under sterile conditions prior to the start of surgery. No additional adjuvants will be administered. Standard perioperative analgesia will be provided to all participants. Receives: Drug: Dexamethasone |
| Perineural Dexmedetomidine | Active comparator | Children in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.5 µg/kg perineural dexmedetomidine (maximum dose per institutional pediatric guidelines). A 22-gauge echogenic needle will be used for block placement under sterile conditions. No additional adjuvants will be administered. Standard perioperative analgesia will be provided to all participants. Receives: Drug: Dexmedetomidine |
| Perineural Dexamethasone + Dexmedetomidine Combination | Active comparator | Children in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg perineural dexamethasone and 0.5 µg/kg perineural dexmedetomidine (maximum doses per institutional pediatric guidelines). The block will be performed with a 22-gauge echogenic needle under sterile conditions before surgery. Standard perioperative analgesia will be provided to all participants. Receives: Drug: Dexamethasone + Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Rescue Analgesia
Time in hours from completion of the popliteal sciatic nerve block to the first administration of rescue analgesic medication. Rescue analgesia will be provided when the FLACC pain score is ≥ 4, or upon patient/parent request. This measure reflects the duration of effective postoperative analgesia provided by the nerve block.
Measured: 0-24 hours postoperatively
Secondary outcomes (14)
Total Opioid Consumption
Total amount of opioid rescue medication administered within the first 24 hours after surgery, converted to morphine milligram equivalents (MME). Includes all postoperative rescue doses documented in the anesthesia and nursing records.
Measured: 0-24 hours postoperatively
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
Measured: 2 hours postoperatively
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
Measured: 4 hours postoperatively
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
Measured: 8 hours postoperatively
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
Measured: 12 hours postoperatively
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
Measured: 24 hours postoperatively
FLACC Pain Scores During Movement
Pain scores assessed during standardized gentle movement of the operated limb using the FLACC scale (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Movement will be performed by a physiotherapist or trained nurse.
Measured: 2 hours postoperatively
FLACC Pain Scores During Movement
Pain scores assessed during standardized gentle movement of the operated limb using the FLACC scale (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Movement will be performed by a physiotherapist or trained nurse.
Measured: 4 hours postoperatively
FLACC Pain Scores During Movement
Pain scores assessed during standardized gentle movement of the operated limb using the FLACC scale (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Movement will be performed by a physiotherapist or trained nurse.
Measured: 8 hours postoperatively
FLACC Pain Scores During Movement
Pain scores assessed during standardized gentle movement of the operated limb using the FLACC scale (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Movement will be performed by a physiotherapist or trained nurse.
Measured: 12 hours postoperatively
FLACC Pain Scores During Movement
Pain scores assessed during standardized gentle movement of the operated limb using the FLACC scale (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Movement will be performed by a physiotherapist or trained nurse.
Measured: 24 hours postoperatively
Incidence of Adverse Events
Number of participants experiencing adverse events possibly related to the block or adjuvants, including excessive sedation, bradycardia, hypotension, local anesthetic systemic toxicity, injection-related complications, prolonged motor block, postoperative nausea or vomiting, or unexpected behavioral responses.
Measured: 0-24 hours postoperatively
Incidence of Persistent Sensory or Motor Deficit (Nerve Injury Screening)
Screening for signs of persistent sensory or motor dysfunction potentially related to the popliteal sciatic nerve block or perineural adjuvants. Follow-up will be conducted through structured telephone interviews with parents or guardians at 1 week and 1 month postoperatively. The assessment will include questions regarding persistent numbness, tingling, altered sensation, weakness of ankle or toe movement, gait abnormalities, or any parental concerns suggestive of nerve dysfunction. If abnormalities are reported, an in-person neurological examination will be offered. This measure assesses the potential impact of perineural dexamethasone, dexmedetomidine, or their combination on nerve integrity.
Measured: 1 week postoperatively
Incidence of Persistent Sensory or Motor Deficit (Nerve Injury Screening)
Screening for signs of persistent sensory or motor dysfunction potentially related to the popliteal sciatic nerve block or perineural adjuvants. Follow-up will be conducted through structured telephone interviews with parents or guardians at 1 week and 1 month postoperatively. The assessment will include questions regarding persistent numbness, tingling, altered sensation, weakness of ankle or toe movement, gait abnormalities, or any parental concerns suggestive of nerve dysfunction. If abnormalities are reported, an in-person neurological examination will be offered. This measure assesses the potential impact of perineural dexamethasone, dexmedetomidine, or their combination on nerve integrity.
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start16 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MAlgorzata Reysenr, MD PhD, Study chair, Poznań University of Medicla Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289620
- Sponsor's protocol ID
- 15/2025
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the primary and secondary outcomes will be made available to qualified researchers upon reasonable request. Shared data will include demographic information, details of the nerve block, intraoperative variables, postoperative pain scores, time to first rescue analgesia, opioid consumption, adverse events, and follow-up information regarding sensory or motor deficits. No direct identifiers or protected health information will be included.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Controlled Trial Comparing Perineural Dexamethasone, Dexmedetomidine, and Their Combination as Adjuvants to Ropivacaine for Popliteal Sciatic Nerve Block in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07289620
- Acronym / sponsor ID
- 15/2025
- Conditions
- Ankle Disease, Foot Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 17 Dec 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.
This clinical study will evaluate three commonly used medications that can be added to local anesthetic during a popliteal sciatic nerve block in children undergoing surgery of the lower leg or foot. These medications-dexamethasone, dexmedetomidine, or a combination of both-may help the nerve block last longer and provide better postoperative pain control.
All participating children will receive a standard popliteal sciatic nerve block with ropivacaine, a commonly used local anesthetic. They will then be randomly assigned to one of three groups: (1) ropivacaine with dexamethasone, (2) ropivacaine with dexmedetomidine, or (3) ropivacaine with both dexamethasone and dexmedetomidine. Neither the children, parents, nor the clinical staff assessing pain will know which medication was given.
The goal of this study is to determine whether the combination of dexamethasone and dexmedetomidine provides longer pain relief and reduces the need for additional pain medication compared with either medication alone. The results may help identify the most effective and safest strategy for improving postoperative comfort in pediatric patients receiving regional anesthesia.
Detailed description
Popliteal sciatic nerve block is frequently used in pediatric anesthesia to provide effective pain control for surgical procedures involving the lower leg, ankle, and foot. Although ropivacaine alone offers good analgesia, its duration is limited, and additional medications (adjuvants) are often added to prolong the effect of the block. Two commonly used adjuvants are dexamethasone, a corticosteroid, and dexmedetomidine, an alpha-2 adrenergic agonist. Each of these medications has been shown to extend the duration of analgesia, but it remains unclear whether combining them provides an additive or potentially synergistic benefit.
This randomized, double-blinded, controlled clinical trial will compare three perineural adjuvant strategies: dexamethasone, dexmedetomidine, and their combination. All participants will receive a single-shot popliteal sciatic nerve block with 0.2% ropivacaine. Children will then be randomized into one of three treatment arms:
- ropivacaine with perineural dexamethasone,
- ropivacaine with perineural dexmedetomidine, or
- ropivacaine with a perineural combination of dexamethasone and dexmedetomidine. Pain scores, block duration, opioid use, and recovery parameters will be assessed by trained observers who are blinded to group assignment. The primary aim is to determine whether the combination of dexamethasone and dexmedetomidine leads to superior analgesia compared with either drug alone. Secondary aims include evaluating the time to first rescue analgesia, total postoperative opioid requirements, behavioral pain scores (e.g., FLACC), adverse events, and early functional recovery.
This study seeks to provide high-quality evidence to guide the optimal choice of perineural adjuvants in pediatric regional anesthesia and may help establish best-practice recommendations for improving postoperative comfort and safety in children undergoing lower-limb surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perineural Dexamethasone | Active comparator | Drug: DexamethasoneChildren in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg perineural dexamethasone (maximum dose per institutional pediatric guidelines). The block will be performed using a 22-gauge echogenic needle under sterile conditions prior to the start of surgery. No additional adjuvants will be administered. Standard perioperative analgesia will be provided to all participants. |
| Perineural Dexmedetomidine | Active comparator | Drug: DexmedetomidineChildren in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.5 µg/kg perineural dexmedetomidine (maximum dose per institutional pediatric guidelines). A 22-gauge echogenic needle will be used for block placement under sterile conditions. No additional adjuvants will be administered. Standard perioperative analgesia will be provided to all participants. |
| Perineural Dexamethasone + Dexmedetomidine Combination | Active comparator | Drug: Dexamethasone + DexmedetomidineChildren in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg perineural dexamethasone and 0.5 µg/kg perineural dexmedetomidine (maximum doses per institutional pediatric guidelines). The block will be performed with a 22-gauge echogenic needle under sterile conditions before surgery. Standard perioperative analgesia will be provided to all participants. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 3 to 12 years.
- Scheduled for elective unilateral lower limb surgery (foot, ankle, or distal lower leg) under general anesthesia with a popliteal sciatic nerve block planned for postoperative analgesia.
- ASA physical status I-III.
- Ability of parents or legal guardians to understand the study procedures and provide written informed consent.
- Child and parents/guardians available for telephone follow-up at 1 week and 1 month after surgery.
Key exclusion criteria (11 listed)
- Refusal of the parents/legal guardians to provide informed consent or refusal of the child to cooperate with anesthesia or study procedures.
- Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any component of the study medications.
- Pre-existing neurological deficit or neuromuscular disease affecting the lower limbs (motor or sensory).
- Coagulopathy or current therapeutic anticoagulation that contraindicates regional anesthesia.
- Local infection, inflammation, or skin lesions at the planned block site.
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 |
|---|---|---|
| DexamethasonePerineural dexamethasone will be administered as an adjuvant to a single-shot popliteal sciatic nerve block. Children will receive 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg dexamethasone, injected under ultrasound guidance using a 22-gauge echogenic needle prior to surgery. The medication will be given as a single perineural dose only. Standard perioperative analgesia will be provided to all participants. | Drug | Perineural Dexamethasone |
| DexmedetomidinePerineural dexmedetomidine will be administered as an adjuvant to a single-shot popliteal sciatic nerve block. Children will receive 0.3 mL/kg of 0.2% ropivacaine combined with 0.5 µg/kg dexmedetomidine, injected under ultrasound guidance with a 22-gauge echogenic needle prior to surgery. The medication will be administered as a single perineural bolus. Standard perioperative analgesia will be provided to all participants. | Drug | Perineural Dexmedetomidine |
| Dexamethasone + DexmedetomidineChildren in this arm will receive a combination of two perineural adjuvants added to a single-shot popliteal sciatic nerve block. The block will include 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg dexamethasone and 0.5 µg/kg dexmedetomidine, administered under ultrasound guidance using a 22-gauge echogenic needle prior to surgery. Both medications will be delivered together as a single perineural bolus. Standard perioperative analgesia will be provided to all participants. | Drug | Perineural Dexamethasone + Dexmedetomidine Combination |
Primary outcome
Time to First Rescue Analgesia
Time frame: 0-24 hours postoperatively
Time in hours from completion of the popliteal sciatic nerve block to the first administration of rescue analgesic medication. Rescue analgesia will be provided when the FLACC pain score is ≥ 4, or upon patient/parent request. This measure reflects the duration of effective postoperative analgesia provided by the nerve block.
14 secondary outcomes
Total Opioid Consumption
Time frame: 0-24 hours postoperatively
FLACC Pain Scores at Rest
Time frame: 2 hours postoperatively
FLACC Pain Scores at Rest
Time frame: 4 hours postoperatively
FLACC Pain Scores at Rest
Time frame: 8 hours postoperatively
FLACC Pain Scores at Rest
Time frame: 12 hours postoperatively
FLACC Pain Scores at Rest
Time frame: 24 hours postoperatively
FLACC Pain Scores During Movement
Time frame: 2 hours postoperatively
FLACC Pain Scores During Movement
Time frame: 4 hours postoperatively
FLACC Pain Scores During Movement
Time frame: 8 hours postoperatively
FLACC Pain Scores During Movement
Time frame: 12 hours postoperatively
FLACC Pain Scores During Movement
Time frame: 24 hours postoperatively
Incidence of Adverse Events
Time frame: 0-24 hours postoperatively
Incidence of Persistent Sensory or Motor Deficit (Nerve Injury Screening)
Time frame: 1 week postoperatively
Incidence of Persistent Sensory or Motor Deficit (Nerve Injury Screening)
Time frame: 1 month postoperatively
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 2 Feb 2026.
- Individual participant dataSharing planned: Yes. the primary and secondary outcomes will be made available to qualified researchers upon reasonable request. Shared data will include demographic information, details of the nerve block, intraoperative variables, postoperative pain scores, time to first rescue analgesia, opioid consumption, adverse events, and follow-up information regarding sensory or motor deficits. No direct identifiers or protected health information will be included.
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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.
MAlgorzata Reysenr, MD PhD study chair
Poznań University of Medicla Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone, Dexmedetomidine and Dexamethasone + Dexmedetomidine in people with Ankle Disease and Foot Diseases, run by Poznan University of Medical Sciences at 1 site in Poland.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 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 Poland. 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.
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?
Contact Malgorzata Reysner, MD PhD (+48 61 873 83 03, mreysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Rescue Analgesia (time frame: 0-24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.