Bupivacaine Versus Bupivacaine Plus Lidocaine in Infraclavicular Block

Phase 4

Completed

• Conditions: Pain, Acute; Analgesia; Postoperative Pain
• Interventions: Drug: Bupivacaine-Lidocaine; Drug: Bupivacaine

• Registration Number: NCT05834023
• Lead Sponsor: Hospital de San Carlos Dr. Benicio Arzola Medina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-27
• Study Start: 2023-05-02
• Primary Completion: 2023-12-29
• Status Verified: 2024-01
• Study Completion: 2024-01-05
• Last Update Submitted: 2024-01-14
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine 0.25% plus Lidocaine 1%	Bupivacaine-Lidocaine	Infraclavicular block with Bupivacaine and Lidocaine
Bupivacaine 0.5%	Bupivacaine	Infraclavicular block with Bupivacaine

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
Duration of surgery	3 hours after skin incision	Time in minutes between skin incision and closure.
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
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.
Length of PACU stay	3 hours after the end of the surgery	The time interval in minutes between PACU arrival to readiness to discharge
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
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.
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.
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.

Trial Locations

Locations (1)

Hospital de San Carlos Dr. Benicio Arzola Medina; 🇨🇱 San Carlos, Ñuble, Chile