Pain, AcutePhase 4NCT05834023
Bupivacaine Versus Bupivacaine Plus Lidocaine in Infraclavicular Block
A Phase 4 study testing Bupivacaine-Lidocaine and Bupivacaine in people with Pain, Acute and Postoperative Pain, run by Hospital de San Carlos Dr. Benicio Arzola Medina at 1 site in Chile.
Trial summary
In this study, the investigators will compare two different anesthetic solutions in the infraclavicular block in patients having forearm, wrist, and hand surgery. The solutions will be bupivacaine 0.5% versus bupivacaine 0.25% plus lidocaine 1%, both associated with epinephrine 5 mcg/ml and dexamethasone 4 mg. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Acute, Postoperative Pain, Analgesia
- What is being tested?
- Bupivacaine-Lidocaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 2 May 2023to 5 Jan 2024
- 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
- Age between 18 and 80 years
- American Society of Anesthesiologists classification 1-3
- Surgery of the forearm, wrist, and hand
- Weight ≥ 80 kilograms
Who cannot join
- Adults who are unable to give their consent
- Infection in the injection site (infraclavicular region)
- Pre-existing neuropathy (assessed by history and physical examination)
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work, i.e., platelets ≤ 100, International Normalized Ratio ≥ 1.4)
- Renal failure (assessed by history and physical examination and if deemed clinically necessary, by blood work, i.e., creatinine ≥ 1.2)
- Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work, i.e., transaminases ≥ 100)
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- Allergy to local anesthetics (LAs)
- Pregnancy or breastfeeding
- Prior surgery in the infraclavicular region
- Chronic pain syndromes requiring opioid intake at home
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital de San Carlos Dr. Benicio Arzola Medina
San Carlos, Región de Ñuble
About this study
Official title: Comparison Between Bupivacaine 0.5% Versus Bupivacaine 0.25% Plus Lidocaine 1% in Ultrasound-guided Infraclavicular Block: a Prospective Randomized Controlled Trial
In this study, the investigators will compare two different anesthetic solutions in the infraclavicular block in patients having forearm, wrist, and hand surgery. The solutions will be bupivacaine 0.5% versus bupivacaine 0.25% plus lidocaine 1%, both associated with epinephrine 5 mcg/ml and dexamethasone 4 mg.
The main objective of this investigation is to demonstrate that using higher concentrations of bupivacaine alone results in a significant block duration increase compared with the mixture of bupivacaine and lidocaine.
- Conditions
- Pain, Acute, Postoperative Pain, Analgesia
- Being tested
- Bupivacaine-Lidocaine, Bupivacaine
- Keywords
- Bupivacaine, Lidocaine, Nerve Block, Infraclavicular Block, Upper Extremity Surgery
- Medical subject headings
- Acute Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-LidocaineDrug
Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.25% + Lidocaine 1% + dexamethasone 4 mg + epinephrine 5 mcg/ml
BupivacaineDrug
Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.5% + dexamethasone 4 mg + epinephrine 5 mcg/ml
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine 0.25% plus Lidocaine 1% | Active comparator | Infraclavicular block with Bupivacaine and Lidocaine Receives: Drug: Bupivacaine-Lidocaine |
| Bupivacaine 0.5% | Experimental | Infraclavicular block with Bupivacaine Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor block duration
The time interval in minutes between the end of the local anesthetic injection and the return of hand mobility.
Measured: 0 - 48 hours after block
Secondary outcomes (21)
Sensory block duration
The time interval in minutes between the end of the local anesthetic injection and the return of hand sensation.
Measured: 0 - 48 hours after block
Analgesic block duration
The time interval in minutes between the end of the local anesthetic injection and the first sensation of pain in the surgical area.
Measured: 0 - 48 hours after block
Sensory and motor block score
The sensorimotor block will be assessed every 5 minutes until 60 minutes after the end of local anesthetic injection using a 16-point composite score evaluating sensory and motor block of musculocutaneous, median, radial, and ulnar nerves.
Sensation will be assessed with a pinprick test in each nerve territory with a 0 to 2-point scale. 0= no block, patients can feel a pin prick; 1= analgesic block, the patient can feel touch but not pinprick; 2= anesthetic block, the patient cannot feel pinprick 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.
Measured: 0 - 60 minutes after block
Block onset time
The time interval in minutes between the end of the local anesthetic injection and a minimal sensorimotor composite score of 14 out of 16 points.
The sensorimotor score is described in Outcome 4.
Measured: 0 - 60 minutes after block
Incidence of successful block
Patients with a minimal sensorimotor score of 14 out of 16 points, with at least 7 points in the sensitive score. The sensorimotor score is described in Outcome 4.
Measured: 0 - 60 minutes after block
Incidence of failed block
Patients with a sensorimotor score of 13 points or less. The sensorimotor score is described in Outcome 4.
Measured: 0 - 60 minutes after block
Incidence of anesthetic block
Ability to proceed with the surgery without general anesthesia, rescue blocks, or local anesthesia infiltration by the surgeon.
Measured: 60 to 120 minutes after the ending time of local anesthetic injection
Procedural pain
Pain related to the nerve block according to 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-point score means the worst imaginable pain.
Measured: Immediately after nerve block
Image time
The time interval in seconds between the probe placement and the acquisition of the final ultrasonographic image.
Measured: 2 hours before surgery
Needle time
The time interval in seconds between the skin infiltration and the end of local anesthetic injection
Measured: 2 hours before surgery
Block performance time
Sum of image and needle time
Measured: 2 hours before surgery
Number of patients requiring general anesthesia
Patients who need general anesthesia to proceed with the surgery
Measured: 60 to 120 minutes after the ending time of local anesthetic injection
Diaphragmatic function
Diaphragmatic excursion in millimeters evaluated by ultrasound in three different times: pre-block, 60 minutes after block, and at the end of the surgery
Measured: From arrival to the pre-anesthesia unit to the end of surgery
Rate of diaphragmatic paresis
Patients with decreased diaphragmatic excursion by 25% to 75% compared with the basal function 60 minutes after the block or at the end of the surgery.
Measured: From 60 minutes after block to the end of the surgery
Rate of diaphragmatic paralysis
Patients with decreased diaphragmatic excursion greater than 75% compared with the basal function, absence of diaphragmatic movement, or paradoxical movement 60 minutes after the block or at the end of the surgery.
Measured: From 60 minutes after block to the end of the surgery
Incidence of rebound pain
Severe pain (NRS ≥ 7) in the surgical area within 24 hours after the block wears off.
Measured: 24 hours after the block wears off
Incidence of nerve block side effects
The presence of Horner syndrome, paresthesia, vascular puncture, hematoma, or local anesthetic systemic toxicity after the nerve block.
Measured: From skin anesthesia to 60 minutes after the nerve block
Postoperative complications
Presence of persistent paresthesia, numbness, or motor deficit in the postoperative period.
Measured: 7 days after surgery
Duration of surgery
Time in minutes between skin incision and closure.
Measured: 3 hours after skin incision
Pain score in the post-anesthesia care unit (PACU)
Highest pain reported by the patient in the PACU according to 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-point score means the worst imaginable pain.
Measured: 3 hours after the end of the surgery
Length of PACU stay
The time interval in minutes between PACU arrival to readiness to discharge
Measured: 3 hours after the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start2 May 2023
- Primary completion29 Dec 2023
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies 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
- Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de San Carlos Dr. Benicio Arzola Medina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Germán Armando Aguilera Ceballos, Hospital de San Carlos Dr. Benicio Arzola Medina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834023
- Sponsor's protocol ID
- CEC-HCHM 05-2023
- Status last verified
- Jan 2024
- First submitted
- 6 Apr 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vrancken D, Theunissen M, Joosten EA, Fiddelers AAA, Hoofwijk DMN, Buhre WFFA, Gramke HF, Stessel BOR. Procedure-Specific Pain Intensity Four Days After Day Surgery and the Relationship with Preoperative Pain: A Prospective Cohort Study. Anesth Pain Med. 2018 Nov 17;8(6):e81366. doi: 10.5812/aapm.81366. eCollection 2018 Dec.
PubMed 30719413Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581.
PubMed 27749354Aguirre J, Del Moral A, Cobo I, Borgeat A, Blumenthal S. The role of continuous peripheral nerve blocks. Anesthesiol Res Pract. 2012;2012:560879. doi: 10.1155/2012/560879. Epub 2012 Jun 18.
PubMed 22761615Chelly JE, Ghisi D, Fanelli A. Continuous peripheral nerve blocks in acute pain management. Br J Anaesth. 2010 Dec;105 Suppl 1:i86-96. doi: 10.1093/bja/aeq322.
PubMed 21148658Sinatra RS, Goldstein R, Sevarino FB. The clinical effectiveness of epidural bupivacaine, bupivacaine with lidocaine, and bupivacaine with fentanyl for labor analgesia. J Clin Anesth. 1991 May-Jun;3(3):219-24; discussion 214-5. doi: 10.1016/0952-8180(91)90164-i.
PubMed 1878235Ribotsky BM, Berkowitz KD, Montague JR. Local anesthetics. Is there an advantage to mixing solutions? J Am Podiatr Med Assoc. 1996 Oct;86(10):487-91. doi: 10.7547/87507315-86-10-487.
PubMed 8918026Nestor CC, Ng C, Sepulveda P, Irwin MG. Pharmacological and clinical implications of local anaesthetic mixtures: a narrative review. Anaesthesia. 2022 Mar;77(3):339-350. doi: 10.1111/anae.15641. Epub 2021 Dec 14.
PubMed 34904711Gadsden J, Hadzic A, Gandhi K, Shariat A, Xu D, Maliakal T, Patel V. The effect of mixing 1.5% mepivacaine and 0.5% bupivacaine on duration of analgesia and latency of block onset in ultrasound-guided interscalene block. Anesth Analg. 2011 Feb;112(2):471-6. doi: 10.1213/ANE.0b013e3182042f7f. Epub 2010 Dec 14.
PubMed 21156983Bobik P, Kosel J, Swirydo P, Talalaj M, Czaban I, Radziwon W. Comparison of the pharmacological properties of 0.375% bupivacaine with epinephrine, 0.5% ropivacaine and a mixture of bupivacaine with epinephrine and lignocaine - a randomized prospective study. J Plast Surg Hand Surg. 2020 Jun;54(3):156-160. doi: 10.1080/2000656X.2020.1720999. Epub 2020 Jan 31.
PubMed 32003278Laur JJ, Bayman EO, Foldes PJ, Rosenquist RW. Triple-blind randomized clinical trial of time until sensory change using 1.5% mepivacaine with epinephrine, 0.5% bupivacaine, or an equal mixture of both for infraclavicular block. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):28-33. doi: 10.1097/AAP.0b013e318236bc30.
PubMed 22157740Almasi R, Rezman B, Kriszta Z, Patczai B, Wiegand N, Bogar L. Onset times and duration of analgesic effect of various concentrations of local anesthetic solutions in standardized volume used for brachial plexus blocks. Heliyon. 2020 Sep 2;6(9):e04718. doi: 10.1016/j.heliyon.2020.e04718. eCollection 2020 Sep.
PubMed 32944664Pongraweewan O, Inchua N, Kitsiripant C, Kongmuang B, Tiwirach W. Onset Time of 2% Lidocaine and 0.5% Bupivacaine Mixture versus 0.5% Bupivacaine Alone using Ultrasound and Double Nerve Stimulation for Infraclavicular Brachial Plexus Anesthesia in ESRD Patients Undergoing Arteriovenous Fistula Creation. J Med Assoc Thai. 2016 May;99(5):589-95.
PubMed 27501616Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10.
PubMed 24413428Chong 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 28252523Desai 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 33456903
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Bupivacaine 0.5% Versus Bupivacaine 0.25% Plus Lidocaine 1% in Ultrasound-guided Infraclavicular Block: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05834023
- Acronym / sponsor ID
- CEC-HCHM 05-2023
- Conditions
- Pain, Acute, Postoperative Pain, Analgesia
- Keywords
- Bupivacaine, Lidocaine, Nerve Block, Infraclavicular Block, Upper Extremity Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital de San Carlos Dr. Benicio Arzola MedinaUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 27 Apr 2023 (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.
In this study, the investigators will compare two different anesthetic solutions in the infraclavicular block in patients having forearm, wrist, and hand surgery. The solutions will be bupivacaine 0.5% versus bupivacaine 0.25% plus lidocaine 1%, both associated with epinephrine 5 mcg/ml and dexamethasone 4 mg.
The main objective of this investigation is to demonstrate that using higher concentrations of bupivacaine alone results in a significant block duration increase compared with the mixture of bupivacaine and lidocaine.
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
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine 0.25% plus Lidocaine 1% | Active comparator | Drug: Bupivacaine-LidocaineInfraclavicular block with Bupivacaine and Lidocaine |
| Bupivacaine 0.5% | Experimental | Drug: BupivacaineInfraclavicular block with Bupivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years
- American Society of Anesthesiologists classification 1-3
- Surgery of the forearm, wrist, and hand
- Weight ≥ 80 kilograms
Key exclusion criteria (10 listed)
- Adults who are unable to give their consent
- Infection in the injection site (infraclavicular region)
- Pre-existing neuropathy (assessed by history and physical examination)
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work, i.e., platelets ≤ 100, International Normalized Ratio ≥ 1.4)
- Renal failure (assessed by history and physical examination and if deemed clinically necessary, by blood work, i.e., creatinine ≥ 1.2)
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-LidocaineInfraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.25% + Lidocaine 1% + dexamethasone 4 mg + epinephrine 5 mcg/ml | Drug | Bupivacaine 0.25% plus Lidocaine 1% |
| BupivacaineInfraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.5% + dexamethasone 4 mg + epinephrine 5 mcg/ml | Drug | Bupivacaine 0.5% |
Primary outcome
Motor block duration
Time frame: 0 - 48 hours after block
The time interval in minutes between the end of the local anesthetic injection and the return of hand mobility.
21 secondary outcomes
Sensory block duration
Time frame: 0 - 48 hours after block
Analgesic block duration
Time frame: 0 - 48 hours after block
Sensory and motor block score
Time frame: 0 - 60 minutes after block
Block onset time
Time frame: 0 - 60 minutes after block
Incidence of successful block
Time frame: 0 - 60 minutes after block
Incidence of failed block
Time frame: 0 - 60 minutes after block
Incidence of anesthetic block
Time frame: 60 to 120 minutes after the ending time of local anesthetic injection
Procedural pain
Time frame: Immediately after nerve block
Image time
Time frame: 2 hours before surgery
Needle time
Time frame: 2 hours before surgery
Block performance time
Time frame: 2 hours before surgery
Number of patients requiring general anesthesia
Time frame: 60 to 120 minutes after the ending time of local anesthetic injection
Diaphragmatic function
Time frame: From arrival to the pre-anesthesia unit to the end of surgery
Rate of diaphragmatic paresis
Time frame: From 60 minutes after block to the end of the surgery
Rate of diaphragmatic paralysis
Time frame: From 60 minutes after block to the end of the surgery
Incidence of rebound pain
Time frame: 24 hours after the block wears off
Incidence of nerve block side effects
Time frame: From skin anesthesia to 60 minutes after the nerve block
Postoperative complications
Time frame: 7 days after surgery
Duration of surgery
Time frame: 3 hours after skin incision
Pain score in the post-anesthesia care unit (PACU)
Time frame: 3 hours after the end of the surgery
Length of PACU stay
Time frame: 3 hours after the end of the 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 Jan 2024.
- Background: PubMed 30719413Vrancken D, Theunissen M, Joosten EA, Fiddelers AAA, Hoofwijk DMN, Buhre WFFA, Gramke HF, Stessel BOR. Procedure-Specific Pain Intensity Four Days After Day Surgery and the Relationship with Preoperative Pain: A Prospective Cohort Study. Anesth Pain Med. 2018 Nov 17;8(6):e81366. doi: 10.5812/aapm.81366. eCollection 2018 Dec.
- Background: PubMed 27749354Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581.
- Background: PubMed 22761615Aguirre J, Del Moral A, Cobo I, Borgeat A, Blumenthal S. The role of continuous peripheral nerve blocks. Anesthesiol Res Pract. 2012;2012:560879. doi: 10.1155/2012/560879. Epub 2012 Jun 18.
- Background: PubMed 21148658Chelly JE, Ghisi D, Fanelli A. Continuous peripheral nerve blocks in acute pain management. Br J Anaesth. 2010 Dec;105 Suppl 1:i86-96. doi: 10.1093/bja/aeq322.
- Background: PubMed 1878235Sinatra RS, Goldstein R, Sevarino FB. The clinical effectiveness of epidural bupivacaine, bupivacaine with lidocaine, and bupivacaine with fentanyl for labor analgesia. J Clin Anesth. 1991 May-Jun;3(3):219-24; discussion 214-5. doi: 10.1016/0952-8180(91)90164-i.
- Background: PubMed 8918026Ribotsky BM, Berkowitz KD, Montague JR. Local anesthetics. Is there an advantage to mixing solutions? J Am Podiatr Med Assoc. 1996 Oct;86(10):487-91. doi: 10.7547/87507315-86-10-487.
- Background: PubMed 34904711Nestor CC, Ng C, Sepulveda P, Irwin MG. Pharmacological and clinical implications of local anaesthetic mixtures: a narrative review. Anaesthesia. 2022 Mar;77(3):339-350. doi: 10.1111/anae.15641. Epub 2021 Dec 14.
- Background: PubMed 21156983Gadsden J, Hadzic A, Gandhi K, Shariat A, Xu D, Maliakal T, Patel V. The effect of mixing 1.5% mepivacaine and 0.5% bupivacaine on duration of analgesia and latency of block onset in ultrasound-guided interscalene block. Anesth Analg. 2011 Feb;112(2):471-6. doi: 10.1213/ANE.0b013e3182042f7f. Epub 2010 Dec 14.
- Background: PubMed 32003278Bobik P, Kosel J, Swirydo P, Talalaj M, Czaban I, Radziwon W. Comparison of the pharmacological properties of 0.375% bupivacaine with epinephrine, 0.5% ropivacaine and a mixture of bupivacaine with epinephrine and lignocaine - a randomized prospective study. J Plast Surg Hand Surg. 2020 Jun;54(3):156-160. doi: 10.1080/2000656X.2020.1720999. Epub 2020 Jan 31.
- Background: PubMed 22157740Laur JJ, Bayman EO, Foldes PJ, Rosenquist RW. Triple-blind randomized clinical trial of time until sensory change using 1.5% mepivacaine with epinephrine, 0.5% bupivacaine, or an equal mixture of both for infraclavicular block. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):28-33. doi: 10.1097/AAP.0b013e318236bc30.
- Background: PubMed 32944664Almasi R, Rezman B, Kriszta Z, Patczai B, Wiegand N, Bogar L. Onset times and duration of analgesic effect of various concentrations of local anesthetic solutions in standardized volume used for brachial plexus blocks. Heliyon. 2020 Sep 2;6(9):e04718. doi: 10.1016/j.heliyon.2020.e04718. eCollection 2020 Sep.
- Background: PubMed 27501616Pongraweewan O, Inchua N, Kitsiripant C, Kongmuang B, Tiwirach W. Onset Time of 2% Lidocaine and 0.5% Bupivacaine Mixture versus 0.5% Bupivacaine Alone using Ultrasound and Double Nerve Stimulation for Infraclavicular Brachial Plexus Anesthesia in ESRD Patients Undergoing Arteriovenous Fistula Creation. J Med Assoc Thai. 2016 May;99(5):589-95.
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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-Lidocaine and Bupivacaine in people with Pain, Acute and Postoperative Pain, run by Hospital de San Carlos Dr. Benicio Arzola Medina 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 4 inclusion and 10 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 Jan 2024. 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: 0 - 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 NCT05834023, which also lists 16 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 Jan 2024.