Analgesia, Pain, Acute, Postoperative Pain
Conditions
Keywords
Bupivacaine, Lidocaine, Nerve Block, Infraclavicular Block, Upper Extremity Surgery
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.
Interventions
DRUGBupivacaine-Lidocaine
Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.25% + Lidocaine 1% + dexamethasone 4 mg + epinephrine 5 mcg/ml
DRUGBupivacaine
Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.5% + dexamethasone 4 mg + epinephrine 5 mcg/ml
Sponsors
Hospital de San Carlos Dr. Benicio Arzola Medina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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. |
| 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 |
| 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 |
Countries
Chile
Outcome results
None listed