Bupivacaine Versus Bupivacaine Plus Lidocaine in Infraclavicular Block

Postoperative Pain Clinical Trial

Official title:

Comparison Between Bupivacaine 0.5% Versus Bupivacaine 0.25% Plus Lidocaine 1% in Ultrasound-guided Infraclavicular Block: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05834023
• Other study ID #: CEC-HCHM 05-2023
• Status: Completed
• Phase: Phase 4
• Start date: May 2, 2023
• Est. completion date: January 5, 2024

Study information

• Verified date: January 2024
• Source: Hospital de San Carlos Dr. Benicio Arzola Medina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 5, 2024
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Pain, Acute
• Postoperative Pain

Intervention

Drug:
• Bupivacaine-Lidocaine
Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.25% + Lidocaine 1% + dexamethasone 4 mg + epinephrine 5 mcg/ml
• Bupivacaine
Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.5% + dexamethasone 4 mg + epinephrine 5 mcg/ml

Locations

Country	Name	City	State
Chile	Hospital de San Carlos Dr. Benicio Arzola Medina	San Carlos	Ñuble

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de San Carlos Dr. Benicio Arzola Medina

Country where clinical trial is conducted

Chile, 

References & Publications (15)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	0 - 48 hours after block
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Image time	The time interval in seconds between the probe placement and the acquisition of the final ultrasonographic image.	2 hours before surgery
Secondary	Needle time	The time interval in seconds between the skin infiltration and the end of local anesthetic injection	2 hours before surgery
Secondary	Block performance time	Sum of image and needle time	2 hours before surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative complications	Presence of persistent paresthesia, numbness, or motor deficit in the postoperative period.	7 days after surgery
Secondary	Duration of surgery	Time in minutes between skin incision and closure.	3 hours after skin incision
Secondary	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
Secondary	Length of PACU stay	The time interval in minutes between PACU arrival to readiness to discharge	3 hours after the end of the surgery