Bupivacaine Versus Bupivacaine Plus Lidocaine in Infraclavicular Block

Sponsor

Hospital de San Carlos Dr. Benicio Arzola Medina (Other)

Overall Status

Recruiting

CT.gov ID

NCT05834023

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute Postoperative Pain Analgesia	Drug: Bupivacaine-Lidocaine Drug: Bupivacaine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled TrialRandomized Controlled Trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 2, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bupivacaine 0.25% plus Lidocaine 1% Infraclavicular block with Bupivacaine and Lidocaine	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
Experimental: Bupivacaine 0.5% Infraclavicular block with Bupivacaine	Drug: Bupivacaine Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.5% + dexamethasone 4 mg + epinephrine 5 mcg/ml

Arm

Intervention/Treatment

Active Comparator: Bupivacaine 0.25% plus Lidocaine 1%

Infraclavicular block with Bupivacaine and Lidocaine

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

Experimental: Bupivacaine 0.5%

Infraclavicular block with Bupivacaine

Drug: Bupivacaine

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

Outcome Measures

Primary Outcome Measures

Motor block duration [0 - 48 hours after block]
The time interval in minutes between the end of the local anesthetic injection and the return of hand mobility.

Secondary Outcome Measures

Sensory block duration [0 - 48 hours after block]
The time interval in minutes between the end of the local anesthetic injection and the return of hand sensation.
Analgesic block duration [0 - 48 hours after block]
The time interval in minutes between the end of the local anesthetic injection and the first sensation of pain in the surgical area.
Sensory and motor block score [0 - 60 minutes after block]
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.
Block onset time [0 - 60 minutes after block]
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.
Incidence of successful block [0 - 60 minutes after 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.
Incidence of failed block [0 - 60 minutes after block]
Patients with a sensorimotor score of 13 points or less. The sensorimotor score is described in Outcome 4.
Incidence of anesthetic block [60 to 120 minutes after the ending time of local anesthetic injection]
Ability to proceed with the surgery without general anesthesia, rescue blocks, or local anesthesia infiltration by the surgeon.
Procedural pain [Immediately after nerve block]
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.
Image time [2 hours before surgery]
The time interval in seconds between the probe placement and the acquisition of the final ultrasonographic image.
Needle time [2 hours before surgery]
The time interval in seconds between the skin infiltration and the end of local anesthetic injection
Block performance time [2 hours before surgery]
Sum of image and needle time
Number of patients requiring general anesthesia [60 to 120 minutes after the ending time of local anesthetic injection]
Patients who need general anesthesia to proceed with the surgery
Diaphragmatic function [From arrival to the pre-anesthesia unit to the end of surgery]
Diaphragmatic excursion in millimeters evaluated by ultrasound in three different times: pre-block, 60 minutes after block, and at the end of the surgery
Rate of diaphragmatic paresis [From 60 minutes after block to the end of the surgery]
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.
Rate of diaphragmatic paralysis [From 60 minutes after block to the end of the surgery]
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.
Incidence of rebound pain [24 hours after the block wears off]
Severe pain (NRS ≥ 7) in the surgical area within 24 hours after the block wears off.
Incidence of nerve block side effects [From skin anesthesia to 60 minutes after the nerve block]
The presence of Horner syndrome, paresthesia, vascular puncture, hematoma, or local anesthetic systemic toxicity after the nerve block.
Postoperative complications [7 days after surgery]
Presence of persistent paresthesia, numbness, or motor deficit in the postoperative period.
Duration of surgery [3 hours after skin incision]
Time in minutes between skin incision and closure.
Pain score in the post-anesthesia care unit (PACU) [3 hours after the end of the surgery]
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.
Length of PACU stay [3 hours after the end of the surgery]
The time interval in minutes between PACU arrival to readiness to discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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