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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine 0.25% plus Lidocaine 1% | Active Comparator | Infraclavicular block with Bupivacaine and Lidocaine |
|
| Bupivacaine 0.5% | Experimental | Infraclavicular block with Bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine-Lidocaine | Drug | Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.25% + Lidocaine 1% + dexamethasone 4 mg + epinephrine 5 mcg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motor block duration | The time interval in minutes between the end of the local anesthetic injection and the return of hand mobility. | 0 - 48 hours after block |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory block duration | The time interval in minutes between the end of the local anesthetic injection and the return of hand sensation. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de San Carlos Dr. Benicio Arzola Medina | San Carlos | Región de Ñuble | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30719413 | Background | 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. | |
| 27749354 |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Randomized Controlled Trial
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A research assistant will prepare the solutions before the procedure, utilizing bupivacaine alone or mixing bupivacaine and lidocaine as appropriate. The operator, patient, and investigator assessing the block will be blinded to group allocation.
| Bupivacaine | Drug | Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.5% + dexamethasone 4 mg + epinephrine 5 mcg/ml |
|
| 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. | 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. | 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. | 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. | 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. | 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. | Immediately after nerve block |
| Image time | The time interval in seconds between the probe placement and the acquisition of the final ultrasonographic image. | 2 hours before surgery |
| Needle time | The time interval in seconds between the skin infiltration and the end of local anesthetic injection | 2 hours before surgery |
| Block performance time | Sum of image and needle time | 2 hours before surgery |
| Number of patients requiring general anesthesia | Patients who need general anesthesia to proceed with the surgery | 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 | 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. | 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. | 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. | 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. | From skin anesthesia to 60 minutes after the nerve block |
| Postoperative complications | Presence of persistent paresthesia, numbness, or motor deficit in the postoperative period. | 7 days after surgery |
| Duration of surgery | Time in minutes between skin incision and closure. | 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. | 3 hours after the end of the surgery |
| Length of PACU stay | The time interval in minutes between PACU arrival to readiness to discharge | 3 hours after the end of the surgery |
| Ilfeld 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. |
| 22761615 | Background | Aguirre 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. |
| 21148658 | Background | Chelly 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. |
| 1878235 | Background | Sinatra 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. |
| 8918026 | Background | Ribotsky 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. |
| 34904711 | Background | Nestor 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. |
| 21156983 | Background | Gadsden 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. |
| 32003278 | Background | Bobik 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. |
| 22157740 | Background | Laur 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. |
| 32944664 | Background | Almasi 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. |
| 27501616 | Background | Pongraweewan 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. |
| 24413428 | Background | Choi 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. |
| 28252523 | Background | Chong 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. |
| 33456903 | Background | 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. |
| 38754989 | Derived | Aguilera G, Tabilo C, Jara A, Aliste J. 0.25% bupivacaine-1% lidocaine vs 0.5% bupivacaine for ultrasound-guided infraclavicular brachial plexus block: a randomized controlled trial. Reg Anesth Pain Med. 2025 Aug 5;50(8):627-634. doi: 10.1136/rapm-2024-105511. |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |