AnalgesiaPhase 4NCT05359731
Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Blockade
A Phase 4 study testing Bupivacaine Hydrochloride and Bupivacaine Hydrochloride with Dexamethasone in people with Analgesia and Acute Pain, run by University of Chile at 1 site in Chile.
Trial summary
The investigators will conduct a prospective, randomized, double-blinded study using an axillary brachial plexus block in patients undergoing elective surgery of the distal forearm and hand to characterize and describe the pharmacokinetics of bupivacaine associated with perineural dexamethasone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia, Acute Pain, Upper Extremity Injury
- What is being tested?
- Bupivacaine Hydrochloride and Bupivacaine Hydrochloride with Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- 28 Jun 2022to 24 Apr 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists classification 1-2
- Real weight between 80 and 100 kg
- Body mass index between 20 and 30
Who cannot join
- Adults who are not capable of giving their own consent
- Medical history or physical findings of pre-existing neuropathy
- 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)
- Pregnancy
- Previous surgery in the axillary region of the surgical side
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Brachial Plexus Blockade for Distal Forearm and Hand Surgery
The investigators will conduct a prospective, randomized, double-blinded study using an axillary brachial plexus block in patients undergoing elective surgery of the distal forearm and hand to characterize and describe the pharmacokinetics of bupivacaine associated with perineural dexamethasone.
The pharmacokinetic analysis will be performed by measuring bupivacaine plasma levels at different time intervals after the blockade (15, 30, 45, 60, and 90 minutes), allowing comparison between 2 different groups: Bupivacaine (B) and Bupivacaine-dexamethasone (BD).
Thus, the hypothesis is that plasma levels of bupivacaine during the first 90 minutes after a blockade are lower in the presence of perineural dexamethasone, suggesting a decrease, at least initially, in systemic absorption from the injection site.
- Conditions
- Analgesia, Acute Pain, Upper Extremity Injury
- Being tested
- Bupivacaine Hydrochloride, Bupivacaine Hydrochloride with Dexamethasone
- Keywords
- Dexamethasone, Nerve Block, Adjuvant, Pharmacokinetic Analysis
- 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.
Bupivacaine HydrochlorideDrug
Patients will receive a total volume of 30 ml of bupivacaine 0.5% in an axillary block with a double puncture.
Bupivacaine Hydrochloride with DexamethasoneDrug
Patients will receive a total volume of 30 ml of bupivacaine 0.5% with Dexamethasone 4 mg in an axillary block with a double puncture.
| Study group | Role | What they receive |
|---|---|---|
| Perineural Bupivacaine | Active comparator | Bupivacaine without Dexamethasone in axillary brachial plexus blockade Receives: Drug: Bupivacaine Hydrochloride |
| Perineural Bupivacaine plus Dexamethasone | Experimental | Bupivacaine with Dexamethasone in axillary brachial plexus blockade Receives: Drug: Bupivacaine Hydrochloride with Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of bupivacaine
Maximum plasmatic level of bupivacaine
Measured: 0 to 90 minutes after the ending time of local anesthetic injection
Secondary outcomes (17)
Plasmatic concentration of bupivacaine at 15 minutes
Plasmatic level of bupivacaine 15 minutes after local anesthetic injection (ng/ml)
Measured: 15 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 30 minutes
Plasmatic level of bupivacaine 30 minutes after local anesthetic injection (ng/ml)
Measured: 30 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 45 minutes
Plasmatic level of bupivacaine 45 minutes after local anesthetic injection (ng/ml)
Measured: 45 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 60 minutes
Plasmatic level of bupivacaine 60 minutes after local anesthetic injection (ng/ml)
Measured: 60 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 90 minutes
Plasmatic level of bupivacaine 90 minutes after local anesthetic injection (ng/ml)
Measured: 90 minutes after the ending time of local anesthetic injection
Time to obtain the maximum plasma concentration of bupivacaine (Tmax)
Time in minutes in which the maximum plasmatic level of bupivacaine is reached
Measured: 0 to 90 minutes after the ending time of local anesthetic injection
Area under the curve of plasma concentration versus time at 90 minutes (AUC90)
Area under the curve at 90 minutes
Measured: 0 to 90 minutes after the ending time of local anesthetic injection
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
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 9.
Measured: 30 minutes after the ending time of local anesthetic injection
Incidence of successful 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
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: 48 hours after the ending time of local anesthetic injection
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: 48 hours after the ending time of local anesthetic injection
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: 48 hours after the ending time of local anesthetic injection
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: During the execution of the nerve blockade
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: From the skin anesthesia to the end of local anesthetic injection
Incidence of nerve block side effects
Determined by the presence of paresthesia, local anesthetic systemic toxicity, vascular puncture after the block.
Measured: From the skin anesthesia to the end of local anesthetic injection
Persistent neurologic deficit
Presence of persistent sensory or motor postoperative deficit.
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 posted4 May 2022
- Study start28 Jun 2022
- Primary completion17 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Bravo Advis, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359731
- Sponsor's protocol ID
- OAIC 1249/22
- Status last verified
- Oct 2023
- First submitted
- 28 Apr 2022
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Desai N, Albrecht E, El-Boghdadly K. Perineural adjuncts for peripheral nerve block. BJA Educ. 2019 Sep;19(9):276-282. doi: 10.1016/j.bjae.2019.05.001. Epub 2019 Jul 6. No abstract available.
PubMed 33456903Leurcharusmee 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 27015546Aliste J, Leurcharusmee P, Engsusophon P, Gordon A, Michelagnoli G, Sriparkdee C, Tiyaprasertkul W, Tran DQ, Van Zundert TC, Finlayson RJ, Tran DQH. A randomized comparison between intravenous and perineural dexamethasone for ultrasound-guided axillary block. Can J Anaesth. 2017 Jan;64(1):29-36. doi: 10.1007/s12630-016-0741-8. Epub 2016 Sep 23.
PubMed 27663451Heesen M, Klimek M, Imberger G, Hoeks SE, Rossaint R, Straube S. Co-administration of dexamethasone with peripheral nerve block: intravenous vs perineural application: systematic review, meta-analysis, meta-regression and trial-sequential analysis. Br J Anaesth. 2018 Feb;120(2):212-227. doi: 10.1016/j.bja.2017.11.062. Epub 2017 Nov 22.
PubMed 29406171Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.
PubMed 25123271Shishido H, Kikuchi S, Heckman H, Myers RR. Dexamethasone decreases blood flow in normal nerves and dorsal root ganglia. Spine (Phila Pa 1976). 2002 Mar 15;27(6):581-6. doi: 10.1097/00007632-200203150-00005.
PubMed 11884905Gonzalez AP, Bernucci F, Pham K, Correa JA, Finlayson RJ, Tran DQ. Minimum effective volume of lidocaine for double-injection ultrasound-guided axillary block. Reg Anesth Pain Med. 2013 Jan-Feb;38(1):16-20. doi: 10.1097/AAP.0b013e3182707176.
PubMed 23146999Kirkham KR, Jacot-Guillarmod A, Albrecht E. Optimal Dose of Perineural Dexamethasone to Prolong Analgesia After Brachial Plexus Blockade: A Systematic Review and Meta-analysis. Anesth Analg. 2018 Jan;126(1):270-279. doi: 10.1213/ANE.0000000000002488.
PubMed 28922230Souza MCO, Marques MP, Duarte G, Lanchote VL. Analysis of bupivacaine enantiomers in plasma as total and unbound concentrations using LC-MS/MS: Application in a pharmacokinetic study of a parturient with placental transfer. J Pharm Biomed Anal. 2019 Feb 5;164:268-275. doi: 10.1016/j.jpba.2018.10.040. Epub 2018 Oct 23.
PubMed 30399533Tran 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 21270721Bravo 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 30640652Ferraro LHC, Takeda A, Barreto CN, Faria B, Assuncao NA. [Pharmacokinetic and clinical effects of two bupivacaine concentrations on axillary brachial plexus block]. Braz J Anesthesiol. 2018 Mar-Apr;68(2):115-121. doi: 10.1016/j.bjan.2017.09.001. Epub 2017 Oct 16.
PubMed 29042063Bravo D, Aguilera G, Giordano A, Layera S, Erpel H, Mora D, Ramirez C, Jara A, Aliste J. Bupivacaine pharmacokinetics in the absence or presence of perineural dexamethasone in axillary block: an exploratory trial. Br J Anaesth. 2026 Mar;136(3):1090-1092. doi: 10.1016/j.bja.2025.12.009. Epub 2026 Jan 16. No abstract available.
PubMed 41547610
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Brachial Plexus Blockade for Distal Forearm and Hand Surgery
- ClinicalTrials.gov ID
- NCT05359731
- Acronym / sponsor ID
- OAIC 1249/22
- Conditions
- Analgesia, Acute Pain, Upper Extremity Injury
- Keywords
- Dexamethasone, Nerve Block, Adjuvant, Pharmacokinetic Analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 4 May 2022 (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 investigators will conduct a prospective, randomized, double-blinded study using an axillary brachial plexus block in patients undergoing elective surgery of the distal forearm and hand to characterize and describe the pharmacokinetics of bupivacaine associated with perineural dexamethasone.
The pharmacokinetic analysis will be performed by measuring bupivacaine plasma levels at different time intervals after the blockade (15, 30, 45, 60, and 90 minutes), allowing comparison between 2 different groups: Bupivacaine (B) and Bupivacaine-dexamethasone (BD).
Thus, the hypothesis is that plasma levels of bupivacaine during the first 90 minutes after a blockade are lower in the presence of perineural dexamethasone, suggesting a decrease, at least initially, in systemic absorption from the injection site.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineural Bupivacaine | Active comparator | Drug: Bupivacaine HydrochlorideBupivacaine without Dexamethasone in axillary brachial plexus blockade |
| Perineural Bupivacaine plus Dexamethasone | Experimental | Drug: Bupivacaine Hydrochloride with DexamethasoneBupivacaine with Dexamethasone in axillary brachial plexus blockade |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists classification 1-2
- Real weight between 80 and 100 kg
- Body mass index between 20 and 30
Key exclusion criteria (8 listed)
- Adults who are not capable of giving their own consent
- Medical history or physical findings of pre-existing neuropathy
- 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 |
|---|---|---|
| Bupivacaine HydrochloridePatients will receive a total volume of 30 ml of bupivacaine 0.5% in an axillary block with a double puncture. | Drug | Perineural Bupivacaine |
| Bupivacaine Hydrochloride with DexamethasonePatients will receive a total volume of 30 ml of bupivacaine 0.5% with Dexamethasone 4 mg in an axillary block with a double puncture. | Drug | Perineural Bupivacaine plus Dexamethasone |
Primary outcome
Maximum plasma concentration (Cmax) of bupivacaine
Time frame: 0 to 90 minutes after the ending time of local anesthetic injection
Maximum plasmatic level of bupivacaine
17 secondary outcomes
Plasmatic concentration of bupivacaine at 15 minutes
Time frame: 15 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 30 minutes
Time frame: 30 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 45 minutes
Time frame: 45 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 60 minutes
Time frame: 60 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 90 minutes
Time frame: 90 minutes after the ending time of local anesthetic injection
Time to obtain the maximum plasma concentration of bupivacaine (Tmax)
Time frame: 0 to 90 minutes after the ending time of local anesthetic injection
Area under the curve of plasma concentration versus time at 90 minutes (AUC90)
Time frame: 0 to 90 minutes after the ending time of local anesthetic injection
Sensory and motor block score
Time frame: 30 minutes after the ending time of local anesthetic injection
Block onset time
Time frame: 30 minutes after the ending time of local anesthetic injection
Incidence of successful block
Time frame: 30 minutes after the ending time of local anesthetic injection
Motor block duration
Time frame: 48 hours after the ending time of local anesthetic injection
Sensory block duration
Time frame: 48 hours after the ending time of local anesthetic injection
Analgesic block duration
Time frame: 48 hours after the ending time of local anesthetic injection
Intensity of pain during block procedure
Time frame: During the execution of the nerve blockade
Block performance time
Time frame: From the skin anesthesia to the end of local anesthetic injection
Incidence of nerve block side effects
Time frame: From the skin anesthesia to the end of local anesthetic injection
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 17 Oct 2023.
- 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 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 27663451Aliste J, Leurcharusmee P, Engsusophon P, Gordon A, Michelagnoli G, Sriparkdee C, Tiyaprasertkul W, Tran DQ, Van Zundert TC, Finlayson RJ, Tran DQH. A randomized comparison between intravenous and perineural dexamethasone for ultrasound-guided axillary block. Can J Anaesth. 2017 Jan;64(1):29-36. doi: 10.1007/s12630-016-0741-8. Epub 2016 Sep 23.
- Background: PubMed 29406171Heesen M, Klimek M, Imberger G, Hoeks SE, Rossaint R, Straube S. Co-administration of dexamethasone with peripheral nerve block: intravenous vs perineural application: systematic review, meta-analysis, meta-regression and trial-sequential analysis. Br J Anaesth. 2018 Feb;120(2):212-227. doi: 10.1016/j.bja.2017.11.062. Epub 2017 Nov 22.
- Background: PubMed 25123271Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.
- Background: PubMed 11884905Shishido H, Kikuchi S, Heckman H, Myers RR. Dexamethasone decreases blood flow in normal nerves and dorsal root ganglia. Spine (Phila Pa 1976). 2002 Mar 15;27(6):581-6. doi: 10.1097/00007632-200203150-00005.
- Background: PubMed 23146999Gonzalez AP, Bernucci F, Pham K, Correa JA, Finlayson RJ, Tran DQ. Minimum effective volume of lidocaine for double-injection ultrasound-guided axillary block. Reg Anesth Pain Med. 2013 Jan-Feb;38(1):16-20. doi: 10.1097/AAP.0b013e3182707176.
- Background: PubMed 28922230Kirkham KR, Jacot-Guillarmod A, Albrecht E. Optimal Dose of Perineural Dexamethasone to Prolong Analgesia After Brachial Plexus Blockade: A Systematic Review and Meta-analysis. Anesth Analg. 2018 Jan;126(1):270-279. doi: 10.1213/ANE.0000000000002488.
- Background: PubMed 30399533Souza MCO, Marques MP, Duarte G, Lanchote VL. Analysis of bupivacaine enantiomers in plasma as total and unbound concentrations using LC-MS/MS: Application in a pharmacokinetic study of a parturient with placental transfer. J Pharm Biomed Anal. 2019 Feb 5;164:268-275. doi: 10.1016/j.jpba.2018.10.040. Epub 2018 Oct 23.
- 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 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 29042063Ferraro LHC, Takeda A, Barreto CN, Faria B, Assuncao NA. [Pharmacokinetic and clinical effects of two bupivacaine concentrations on axillary brachial plexus block]. Braz J Anesthesiol. 2018 Mar-Apr;68(2):115-121. doi: 10.1016/j.bjan.2017.09.001. Epub 2017 Oct 16.
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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 Bupivacaine Hydrochloride and Bupivacaine Hydrochloride with Dexamethasone in people with Analgesia and Acute Pain, 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 3 inclusion and 8 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 17 Oct 2023. 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?
Maximum plasma concentration (Cmax) of bupivacaine (time frame: 0 to 90 minutes after the ending time of local anesthetic injection). 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 NCT05359731, which also lists 13 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 17 Oct 2023.