Clinical trial NCT05834023: Bupivacaine Versus Bupivacaine Plus Lidocaine in Infraclavicular Block
Official title: Comparison Between Bupivacaine 0.5% Versus Bupivacaine 0.25% Plus Lidocaine 1% in Ultrasound-guided Infraclavicular Block: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Acute
Postoperative Pain
Analgesia
Keywords: Bupivacaine
Lidocaine
Nerve Block
Infraclavicular Block
Upper Extremity Surgery
Lead sponsor: Hospital de San Carlos Dr. Benicio Arzola Medina
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Motor block duration
timeFrame: 0 - 48 hours after block
Secondary outcomes:
measure: Sensory block duration
timeFrame: 0 - 48 hours after block
measure: Analgesic block duration
timeFrame: 0 - 48 hours after block
measure: Sensory and motor block score
timeFrame: 0 - 60 minutes after block
measure: Block onset time
timeFrame: 0 - 60 minutes after block
measure: Incidence of successful block
timeFrame: 0 - 60 minutes after block
measure: Incidence of failed block
timeFrame: 0 - 60 minutes after block
measure: Incidence of anesthetic block
timeFrame: 60 to 120 minutes after the ending time of local anesthetic injection
measure: Procedural pain
timeFrame: Immediately after nerve block
measure: Image time
timeFrame: 2 hours before surgery
measure: Needle time
timeFrame: 2 hours before surgery
measure: Block performance time
timeFrame: 2 hours before surgery
measure: Number of patients requiring general anesthesia
timeFrame: 60 to 120 minutes after the ending time of local anesthetic injection
measure: Diaphragmatic function
timeFrame: From arrival to the pre-anesthesia unit to the end of surgery
measure: Rate of diaphragmatic paresis
timeFrame: From 60 minutes after block to the end of the surgery
measure: Rate of diaphragmatic paralysis
timeFrame: From 60 minutes after block to the end of the surgery
measure: Incidence of rebound pain
timeFrame: 24 hours after the block wears off
measure: Incidence of nerve block side effects
timeFrame: From skin anesthesia to 60 minutes after the nerve block
measure: Postoperative complications
timeFrame: 7 days after surgery
measure: Duration of surgery
timeFrame: 3 hours after skin incision
measure: Pain score in the post-anesthesia care unit (PACU)
timeFrame: 3 hours after the end of the surgery
measure: Length of PACU stay
timeFrame: 3 hours after the end of the surgery
Other outcomes:
Locations:
city: San Carlos
country: Chile
facility: Hospital de San Carlos Dr. Benicio Arzola Medina
state: Ñuble
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.