Bupivacaine Versus Bupivacaine Plus Lidocaine in Infraclavicular Block

NCT05834023 | Completed Phase 4 DMC

• 1 other identifier: CEC-HCHM 05-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Bupivacaine; Lidocaine; Nerve Block; Infraclavicular Block; Upper Extremity Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (21)

• Sensory block duration

  0 - 48 hours after block

• Analgesic block duration

  0 - 48 hours after block

• Sensory and motor block score

  0 - 60 minutes after block

• Block onset time

  0 - 60 minutes after block

• Incidence of successful block

  0 - 60 minutes after block

Study Arms (2)

Bupivacaine 0.25% plus Lidocaine 1%

ACTIVE COMPARATOR

Infraclavicular block with Bupivacaine and Lidocaine

Drug: Bupivacaine-Lidocaine

Bupivacaine 0.5%

EXPERIMENTAL

Infraclavicular block with Bupivacaine

Drug: Bupivacaine

Interventions

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

Bupivacaine 0.25% plus Lidocaine 1%

Bupivacaine DRUG

Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.5% + dexamethasone 4 mg + epinephrine 5 mcg/ml

Bupivacaine 0.5%

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years
• American Society of Anesthesiologists classification 1-3
• Surgery of the forearm, wrist, and hand
• Weight ≥ 80 kilograms

You may not qualify if:

• 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)
• Allergy to local anesthetics (LAs)
• Pregnancy or breastfeeding
• Prior surgery in the infraclavicular region
• Chronic pain syndromes requiring opioid intake at home

Sponsors & Collaborators

• Hospital de San Carlos Dr. Benicio Arzola Medina: lead

Study Sites (1)

Hospital de San Carlos Dr. Benicio Arzola Medina

San Carlos, Región de Ñuble, Chile

Location

Related Publications (16)

• 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.

  PMID: 30719413 BACKGROUND

• 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.

  PMID: 27749354 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.

  PMID: 22761615 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.

  PMID: 21148658 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.

  PMID: 1878235 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.

  PMID: 8918026 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.

  PMID: 34904711 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.

  PMID: 21156983 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.

  PMID: 32003278 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.

  PMID: 22157740 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.

  PMID: 32944664 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.

  PMID: 27501616 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.

  PMID: 24413428 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.

  PMID: 28252523 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.

  PMID: 33456903 BACKGROUND

• 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.

  PMID: 38754989 DERIVED

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 27, 2023
• Study Start: May 2, 2023
• Primary Completion: December 29, 2023
• Study Completion: January 5, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

CL (1)