Back to resultsBupivacaine Versus Bupivacaine Plus Lidocaine in Infraclavicular Block
Primary Purpose
Pain, Acute, Postoperative Pain, Analgesia
Status
Recruiting
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Bupivacaine-Lidocaine
Bupivacaine
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Acute focused on measuring Bupivacaine, Lidocaine, Nerve Block, Infraclavicular Block, Upper Extremity Surgery
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
Sites / Locations
- Hospital de San Carlos Dr. Benicio Arzola MedinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Bupivacaine 0.25% plus Lidocaine 1%
Bupivacaine 0.5%
Arm Description
Infraclavicular block with Bupivacaine and Lidocaine
Infraclavicular block with Bupivacaine
Outcomes
Primary Outcome Measures
Motor block duration
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
The time interval in minutes between the end of the local anesthetic injection and the return of hand sensation.
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.
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.
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.
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.
Incidence of failed block
Patients with a sensorimotor score of 13 points or less. The sensorimotor score is described in Outcome 4.
Incidence of anesthetic block
Ability to proceed with the surgery without general anesthesia, rescue blocks, or local anesthesia infiltration by the surgeon.
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.
Image time
The time interval in seconds between the probe placement and the acquisition of the final ultrasonographic image.
Needle time
The time interval in seconds between the skin infiltration and the end of local anesthetic injection
Block performance time
Sum of image and needle time
Number of patients requiring general anesthesia
Patients who need general anesthesia to proceed with the surgery
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
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.
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.
Incidence of rebound pain
Severe pain (NRS ≥ 7) in the surgical area within 24 hours after the block wears off.
Incidence of nerve block side effects
The presence of Horner syndrome, paresthesia, vascular puncture, hematoma, or local anesthetic systemic toxicity after the nerve block.
Postoperative complications
Presence of persistent paresthesia, numbness, or motor deficit in the postoperative period.
Duration of surgery
Time in minutes between skin incision and closure.
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.
Length of PACU stay
The time interval in minutes between PACU arrival to readiness to discharge
Full Information
NCT ID
NCT05834023
First Posted
April 6, 2023
Last Updated
May 2, 2023
Sponsor
Hospital de San Carlos Dr. Benicio Arzola Medina
1. Study Identification
Unique Protocol Identification Number
NCT05834023
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de San Carlos Dr. Benicio Arzola Medina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Postoperative Pain, Analgesia
Keywords
Bupivacaine, Lidocaine, Nerve Block, Infraclavicular Block, Upper Extremity Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine 0.25% plus Lidocaine 1%
Arm Type
Active Comparator
Arm Description
Infraclavicular block with Bupivacaine and Lidocaine
Arm Title
Bupivacaine 0.5%
Arm Type
Experimental
Arm Description
Infraclavicular block with Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-Lidocaine
Intervention Description
Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.25% + Lidocaine 1% + dexamethasone 4 mg + epinephrine 5 mcg/ml
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.5% + dexamethasone 4 mg + epinephrine 5 mcg/ml
Primary Outcome Measure Information:
Title
Motor block duration
Description
The time interval in minutes between the end of the local anesthetic injection and the return of hand mobility.
Time Frame
0 - 48 hours after block
Secondary Outcome Measure Information:
Title
Sensory block duration
Description
The time interval in minutes between the end of the local anesthetic injection and the return of hand sensation.
Time Frame
0 - 48 hours after block
Title
Analgesic block duration
Description
The time interval in minutes between the end of the local anesthetic injection and the first sensation of pain in the surgical area.
Time Frame
0 - 48 hours after block
Title
Sensory and motor block score
Description
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.
Time Frame
0 - 60 minutes after block
Title
Block onset time
Description
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.
Time Frame
0 - 60 minutes after block
Title
Incidence of successful block
Description
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.
Time Frame
0 - 60 minutes after block
Title
Incidence of failed block
Description
Patients with a sensorimotor score of 13 points or less. The sensorimotor score is described in Outcome 4.
Time Frame
0 - 60 minutes after block
Title
Incidence of anesthetic block
Description
Ability to proceed with the surgery without general anesthesia, rescue blocks, or local anesthesia infiltration by the surgeon.
Time Frame
60 to 120 minutes after the ending time of local anesthetic injection
Title
Procedural pain
Description
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.
Time Frame
Immediately after nerve block
Title
Image time
Description
The time interval in seconds between the probe placement and the acquisition of the final ultrasonographic image.
Time Frame
2 hours before surgery
Title
Needle time
Description
The time interval in seconds between the skin infiltration and the end of local anesthetic injection
Time Frame
2 hours before surgery
Title
Block performance time
Description
Sum of image and needle time
Time Frame
2 hours before surgery
Title
Number of patients requiring general anesthesia
Description
Patients who need general anesthesia to proceed with the surgery
Time Frame
60 to 120 minutes after the ending time of local anesthetic injection
Title
Diaphragmatic function
Description
Diaphragmatic excursion in millimeters evaluated by ultrasound in three different times: pre-block, 60 minutes after block, and at the end of the surgery
Time Frame
From arrival to the pre-anesthesia unit to the end of surgery
Title
Rate of diaphragmatic paresis
Description
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.
Time Frame
From 60 minutes after block to the end of the surgery
Title
Rate of diaphragmatic paralysis
Description
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.
Time Frame
From 60 minutes after block to the end of the surgery
Title
Incidence of rebound pain
Description
Severe pain (NRS ≥ 7) in the surgical area within 24 hours after the block wears off.
Time Frame
24 hours after the block wears off
Title
Incidence of nerve block side effects
Description
The presence of Horner syndrome, paresthesia, vascular puncture, hematoma, or local anesthetic systemic toxicity after the nerve block.
Time Frame
From skin anesthesia to 60 minutes after the nerve block
Title
Postoperative complications
Description
Presence of persistent paresthesia, numbness, or motor deficit in the postoperative period.
Time Frame
7 days after surgery
Title
Duration of surgery
Description
Time in minutes between skin incision and closure.
Time Frame
3 hours after skin incision
Title
Pain score in the post-anesthesia care unit (PACU)
Description
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.
Time Frame
3 hours after the end of the surgery
Title
Length of PACU stay
Description
The time interval in minutes between PACU arrival to readiness to discharge
Time Frame
3 hours after the end of the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Germán Aguilera
Phone
+56985205514
Email
german.aguilera@gmail.com
Facility Information:
Facility Name
Hospital de San Carlos Dr. Benicio Arzola Medina
City
San Carlos
State/Province
Ñuble
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Germán Aguilera, MD
12. IPD Sharing Statement
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Bupivacaine Versus Bupivacaine Plus Lidocaine in Infraclavicular Block
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