AnalgesiaPhase 4NCT04875039
Dexametasone Versus Dexametasone Plus Dexmedetomidine in Nerve Blocks
A Phase 4 study testing Dexamethasone and Dexmedetomidine-Dexamethasone in people with Analgesia and Pain, Acute, run by University of Chile at 1 site in Chile.
Trial summary
This study will compare perineural dexamethasone 2mg and perineural mixture of dexamethasone 2mg plus dexmedetomidine 50mcg DX plus DXD as adjuvants to local anesthetics for ultrasound-guided infraclavicular brachial plexus blocks (ICBs). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Pain, Acute, Upper Extremity Injury
- What is being tested?
- Dexamethasone and Dexmedetomidine-Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 31 Aug 2021to 1 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists classification 1-3
- Body mass index between 20 and 35
Who cannot join
- Adults who are unable to give their own consent
- Pre-existing neuropathy (assessed by history and physical examination)
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- Allergy to local anesthetics (LAs)
Show all 9Show fewer
- Pregnancy
- Prior surgery in the infraclavicular region
- Chronic pain syndromes requiring opioid intake at home
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison Between Perineural Dexamethasone and Perineural Mixture of Dexamethasone-Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Block
This study will compare perineural dexamethasone 2mg and perineural mixture of dexamethasone 2mg plus dexmedetomidine 50mcg DX plus DXD as adjuvants to local anesthetics for ultrasound-guided infraclavicular brachial plexus blocks (ICBs). The protocol is designed as a superiority trial and hypothesizes that the mixture of both drugs results in longer block duration. Furthermore, since analgesic and sensory duration can be influenced by the intake of pain medications and surgical trauma to small cutaneous nerves, respectively, motor block duration was selected as the main outcome to better target the action of both adjuvants on the brachial plexus.
Read the detailed description
With the approval of Ethics Committee of the Hospital Clínico Universidad de Chile, a total of 50 patients undergoing upper extremity surgery (elbow and below) will be recruited. Recruitment will be carried out by an investigator not involved in patient care in the preoperative clinic or during routine preoperative visits.
All ICBs will be supervised by one of the coauthors and conducted preoperatively in an induction room.
After skin disinfection and draping, the ICB will be performed with a previously described technique. In both groups, a proven 90% effective volume of 35 mL of local anesthetic solution will be injected. As LA solution, it will be used a mixture of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL. The injectate will be slowly injected through the block needle.
Patients will be randomized to receive the study drug, either PN 2 mg dexamethasone or a combination of PN 2 mg dexamethasone with 50 ug dexmedetomidine, mixed with the above-mentioned LA solution.
A research assistant (licensed anesthesiologist) will prepare the local anesthetic solutions and will add the study drug following the randomization order. The operator, patient and investigator assessing the block will be blinded to group allocation.
The primary outcome will be the duration of the motor block (defined as the temporal interval between the end of LA injection through the block needle and the return of movement to the hand and fingers) for patients with successful ICBs. Patients will be provided with a data sheet and asked to record the time at which motor function returns. An investigator blinded to group allocation will collect this data sheet in person (inpatients) or by phone (outpatients) on postoperative day 1.
- Conditions
- Analgesia, Pain, Acute, Upper Extremity Injury
- Being tested
- Dexamethasone, Dexmedetomidine-Dexamethasone
- Keywords
- dexamethasone, dexmedetomidine, nerve block, adjuvants
- Medical subject headings
- Agnosia, Acute Pain, Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
dexamethasone 2 mg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach.
Dexmedetomidine-DexamethasoneDrug
A mixture of dexamethasone 2mg with dexmedetomidine 50mcg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach.
| Study group | Role | What they receive |
|---|---|---|
| Perineural dexamethasone | Active comparator | Addition of dexamethasone 2mg to local anesthetics in infraclavicular brachial plexus block Receives: Drug: Dexamethasone |
| Perineural dexamethasone plus dexmedetomidine | Experimental | Addition of dexamethasone plus dexmedetomidine to local anesthetics in infraclavicular brachial plexus block Receives: Drug: Dexmedetomidine-Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor block duration
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of return of hand and fingers movement
Measured: 24-48 hours after block
Secondary outcomes (14)
Sensory block duration
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of the return of hand and fingers sensation
Measured: Time Frame: 24-48 hours after nerve block
Analgesic block duration
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of the first sensation of pain in the surgical area
Measured: 24-48 hours after nerve block
Block performance time
Sum of: 1- the acquisition time of the ultrasonographic image. and 2- the time to perform the block itself (from the skin anesthesia to the end of local anesthetic injection)
Measured: 1 hour before surgery
Intensity of pain during block procedure
Evaluated with the Numeric Rating Scale for Pain. This scale is graduated from 0 to 10 points. A 0-point score represents the absence of pain, and a 10-points score represents the worst imaginable pain. Patients will be asked to rate their pain verbally with this scale. The blinded assessor will register the score reported.
Measured: 1 hour before surgery
Block onset time
Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points. The sensorimotor score is described in outcome 7.
Measured: 1 hour before surgery
Sensory and motor block score
The sensorimotor block will be assessed every 5 minutes until 30 minutes after the end of local anesthetic injection using a 16-point composite score evaluating sensory and motor block of musculocutaneous, medium, radial, and ulnar nerves.
Sensation will be assessed with ice in each nerve territory with a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, the patient can feel touch but not cold; 2= anesthetic block, the patient cannot feel cold or touch.
The motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Successful blocks at 30 minutes correlate with a final score ( sum of all individual sensory and motor scores) of at least 14 points out of 16.
Measured: 30 minutes after the ending time of local anesthetic injection
Incidence of complete block
Percentage of blocks with a minimal sensorimotor composite score of 14 points out of a maximum of 16 points at 30 minutes after the injection
Measured: 30 minutes after the ending time of local anesthetic injection
Incidence of surgical anesthesia
Ability to proceed with surgery without the need for intravenous narcotics, general anesthesia, rescue blocks or local anesthesia infiltration by the surgeon
Measured: 30-60 minutes after the ending time of local anesthetic injection
Incidence of nerve block side effects
Determined by the presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, Horner syndrome or hoarseness after the block.
Measured: 0 minutes after skin disinfection to 30 minutes after the nerve block
Respiratory depression
Presence of low respiratory rates (lower than 8 breaths per minute) or persistent oxygen requirements (pulse oximetry lower than 90% without supplementary oxygen).
The respiratory rate and pulse oximetry are continuously measured intra- and post-operatively (in the post-anesthetic care unit) as a standard of care with a multiparameter monitor. Alarms are set to alert when predetermined levels are reached
Measured: 30 minutes after the nerve block to 2 hours after surgery
Bradycardia
Defined as a heart rate lower than 50 beats per minute. The heart rate is continuously measured intra- and post-operatively (in the post-anesthetic care unit) as a standard of care with a multiparameter monitor. Alarms are set to alert when predetermined levels are reached
Measured: 30 minutes after the nerve block to 2 hours after surgery
Hypotension
Mean arterial pressure lower than 60 mmHg. The blood pressure is measured intra- and post-operatively (in the post-anesthetic care unit) as a standard of care with a multiparameter monitor. Alarms are set to alert when predetermined levels are reached
Measured: 30 minutes after the nerve block to 2 hours after surgery
Postoperative persistent sedation
Persistent sedation after surgery using Ramsay sedation scale. The scale has 6 points from 1 to 6. A higher score represents a more sedated patient.
1= anxious, agitated or restless; 2= co-operative, oriented and tranquil; 3= responds to command only; 4= brisk response to light pain or loud auditory stimulus; 5= sluggish response to light pain or loud auditory stimulus; 6= no response.
Measured: 2 hours after surgery
Persistent neurologic deficit
Presence of persistent sensory or motor postoperative deficit. The patients will be contacted by telephone and inquired about any sensory or motor deficit in the operated extremity.
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start31 Aug 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- blinded-randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Aliste, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875039
- Sponsor's protocol ID
- OAIC 1091/19
- Status last verified
- Mar 2022
- First submitted
- 27 Apr 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.
PubMed 20048654Tran DQ, Dugani S, Dyachenko A, Correa JA, Finlayson RJ. Minimum effective volume of lidocaine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):190-4. doi: 10.1097/AAP.0b013e31820d4266.
PubMed 21270721Leurcharusmee P, Aliste J, Van Zundert TC, Engsusophon P, Arnuntasupakul V, Tiyaprasertkul W, Tangjitbampenbun A, Ah-Kye S, Finlayson RJ, Tran DQ. A Multicenter Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Block. Reg Anesth Pain Med. 2016 May-Jun;41(3):328-33. doi: 10.1097/AAP.0000000000000386.
PubMed 27015546Chong MA, Berbenetz NM, Lin C, Singh S. Perineural Versus Intravenous Dexamethasone as an Adjuvant for Peripheral Nerve Blocks: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2017 May/Jun;42(3):319-326. doi: 10.1097/AAP.0000000000000571.
PubMed 28252523Vorobeichik L, Brull R, Abdallah FW. Evidence basis for using perineural dexmedetomidine to enhance the quality of brachial plexus nerve blocks: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2017 Feb;118(2):167-181. doi: 10.1093/bja/aew411.
PubMed 28100520Bravo D, Aliste J, Layera S, Fernandez D, Leurcharusmee P, Samerchua A, Tangjitbampenbun A, Watanitanon A, Arnuntasupakul V, Tunprasit C, Gordon A, Finlayson RJ, Tran DQ. A multicenter, randomized comparison between 2, 5, and 8 mg of perineural dexamethasone for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jan;44(1):46-51. doi: 10.1136/rapm-2018-000032.
PubMed 30640652Aliste J, Layera S, Bravo D, Fernandez D, Jara A, Garcia A, Finlayson RJ, Tran DQ. Randomized comparison between perineural dexamethasone and dexmedetomidine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jul 11:rapm-2019-100680. doi: 10.1136/rapm-2019-100680. Online ahead of print.
PubMed 31300595Aliste J, Layera S, Bravo D, Aguilera G, Erpel H, Garcia A, Lizama M, Finlayson RJ, Tran D. Randomized comparison between perineural dexamethasone and combined perineural dexamethasone-dexmedetomidine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2022 Jun 21:rapm-2022-103760. doi: 10.1136/rapm-2022-103760. Online ahead of print.
PubMed 35728840
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Between Perineural Dexamethasone and Perineural Mixture of Dexamethasone-Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Block
- ClinicalTrials.gov ID
- NCT04875039
- Acronym / sponsor ID
- OAIC 1091/19
- Conditions
- Analgesia, Pain, Acute, Upper Extremity Injury
- Keywords
- dexamethasone, dexmedetomidine, nerve block, adjuvants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 6 May 2021 (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 study will compare perineural dexamethasone 2mg and perineural mixture of dexamethasone 2mg plus dexmedetomidine 50mcg DX plus DXD as adjuvants to local anesthetics for ultrasound-guided infraclavicular brachial plexus blocks (ICBs). The protocol is designed as a superiority trial and hypothesizes that the mixture of both drugs results in longer block duration. Furthermore, since analgesic and sensory duration can be influenced by the intake of pain medications and surgical trauma to small cutaneous nerves, respectively, motor block duration was selected as the main outcome to better target the action of both adjuvants on the brachial plexus.
Detailed description
With the approval of Ethics Committee of the Hospital Clínico Universidad de Chile, a total of 50 patients undergoing upper extremity surgery (elbow and below) will be recruited. Recruitment will be carried out by an investigator not involved in patient care in the preoperative clinic or during routine preoperative visits.
All ICBs will be supervised by one of the coauthors and conducted preoperatively in an induction room.
After skin disinfection and draping, the ICB will be performed with a previously described technique. In both groups, a proven 90% effective volume of 35 mL of local anesthetic solution will be injected. As LA solution, it will be used a mixture of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL. The injectate will be slowly injected through the block needle.
Patients will be randomized to receive the study drug, either PN 2 mg dexamethasone or a combination of PN 2 mg dexamethasone with 50 ug dexmedetomidine, mixed with the above-mentioned LA solution.
A research assistant (licensed anesthesiologist) will prepare the local anesthetic solutions and will add the study drug following the randomization order. The operator, patient and investigator assessing the block will be blinded to group allocation.
The primary outcome will be the duration of the motor block (defined as the temporal interval between the end of LA injection through the block needle and the return of movement to the hand and fingers) for patients with successful ICBs. Patients will be provided with a data sheet and asked to record the time at which motor function returns. An investigator blinded to group allocation will collect this data sheet in person (inpatients) or by phone (outpatients) on postoperative day 1.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- blinded-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Perineural dexamethasone | Active comparator | Drug: DexamethasoneAddition of dexamethasone 2mg to local anesthetics in infraclavicular brachial plexus block |
| Perineural dexamethasone plus dexmedetomidine | Experimental | Drug: Dexmedetomidine-DexamethasoneAddition of dexamethasone plus dexmedetomidine to local anesthetics in infraclavicular brachial plexus block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists classification 1-3
- Body mass index between 20 and 35
Key exclusion criteria (9 listed)
- Adults who are unable to give their own consent
- Pre-existing neuropathy (assessed by history and physical examination)
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
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 |
|---|---|---|
| Dexamethasonedexamethasone 2 mg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach. | Drug | Perineural dexamethasone |
| Dexmedetomidine-DexamethasoneA mixture of dexamethasone 2mg with dexmedetomidine 50mcg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach. | Drug | Perineural dexamethasone plus dexmedetomidine |
Primary outcome
Motor block duration
Time frame: 24-48 hours after block
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of return of hand and fingers movement
14 secondary outcomes
Sensory block duration
Time frame: Time Frame: 24-48 hours after nerve block
Analgesic block duration
Time frame: 24-48 hours after nerve block
Block performance time
Time frame: 1 hour before surgery
Intensity of pain during block procedure
Time frame: 1 hour before surgery
Block onset time
Time frame: 1 hour before surgery
Sensory and motor block score
Time frame: 30 minutes after the ending time of local anesthetic injection
Incidence of complete block
Time frame: 30 minutes after the ending time of local anesthetic injection
Incidence of surgical anesthesia
Time frame: 30-60 minutes after the ending time of local anesthetic injection
Incidence of nerve block side effects
Time frame: 0 minutes after skin disinfection to 30 minutes after the nerve block
Respiratory depression
Time frame: 30 minutes after the nerve block to 2 hours after surgery
Bradycardia
Time frame: 30 minutes after the nerve block to 2 hours after surgery
Hypotension
Time frame: 30 minutes after the nerve block to 2 hours after surgery
Postoperative persistent sedation
Time frame: 2 hours after surgery
Persistent neurologic deficit
Time frame: 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 20048654Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.
- Background: PubMed 21270721Tran DQ, Dugani S, Dyachenko A, Correa JA, Finlayson RJ. Minimum effective volume of lidocaine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):190-4. doi: 10.1097/AAP.0b013e31820d4266.
- Background: PubMed 27015546Leurcharusmee P, Aliste J, Van Zundert TC, Engsusophon P, Arnuntasupakul V, Tiyaprasertkul W, Tangjitbampenbun A, Ah-Kye S, Finlayson RJ, Tran DQ. A Multicenter Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Block. Reg Anesth Pain Med. 2016 May-Jun;41(3):328-33. doi: 10.1097/AAP.0000000000000386.
- Background: PubMed 28252523Chong MA, Berbenetz NM, Lin C, Singh S. Perineural Versus Intravenous Dexamethasone as an Adjuvant for Peripheral Nerve Blocks: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2017 May/Jun;42(3):319-326. doi: 10.1097/AAP.0000000000000571.
- Background: PubMed 28100520Vorobeichik L, Brull R, Abdallah FW. Evidence basis for using perineural dexmedetomidine to enhance the quality of brachial plexus nerve blocks: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2017 Feb;118(2):167-181. doi: 10.1093/bja/aew411.
- Background: PubMed 30640652Bravo D, Aliste J, Layera S, Fernandez D, Leurcharusmee P, Samerchua A, Tangjitbampenbun A, Watanitanon A, Arnuntasupakul V, Tunprasit C, Gordon A, Finlayson RJ, Tran DQ. A multicenter, randomized comparison between 2, 5, and 8 mg of perineural dexamethasone for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jan;44(1):46-51. doi: 10.1136/rapm-2018-000032.
- Background: PubMed 31300595Aliste J, Layera S, Bravo D, Fernandez D, Jara A, Garcia A, Finlayson RJ, Tran DQ. Randomized comparison between perineural dexamethasone and dexmedetomidine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jul 11:rapm-2019-100680. doi: 10.1136/rapm-2019-100680. Online ahead of print.
- Derived from this study: PubMed 35728840Aliste J, Layera S, Bravo D, Aguilera G, Erpel H, Garcia A, Lizama M, Finlayson RJ, Tran D. Randomized comparison between perineural dexamethasone and combined perineural dexamethasone-dexmedetomidine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2022 Jun 21:rapm-2022-103760. doi: 10.1136/rapm-2022-103760. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Dexmedetomidine-Dexamethasone in people with Analgesia and Pain, Acute, run by University of Chile at 1 site in Chile.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 4 Mar 2022. 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 Chile. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Motor block duration (time frame: 24-48 hours after block). 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 NCT04875039, which also lists 8 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 4 Mar 2022.