NCT05834023
Completed
Phase 4
Comparison Between Bupivacaine 0.5% Versus Bupivacaine 0.25% Plus Lidocaine 1% in Ultrasound-guided Infraclavicular Block: a Prospective Randomized Controlled Trial
Hospital de San Carlos Dr. Benicio Arzola Medina1 site in 1 country40 target enrollmentMay 2, 2023
Overview
- Phase
- Phase 4
- Intervention
- Bupivacaine-Lidocaine
- Conditions
- Pain, Acute
- Sponsor
- Hospital de San Carlos Dr. Benicio Arzola Medina
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Motor block duration
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Germán Armando Aguilera Ceballos
Principal Investigator
Hospital de San Carlos Dr. Benicio Arzola Medina
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
Arms & Interventions
Bupivacaine 0.25% plus Lidocaine 1%
Infraclavicular block with Bupivacaine and Lidocaine
Intervention: Bupivacaine-Lidocaine
Bupivacaine 0.5%
Infraclavicular block with Bupivacaine
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Motor block duration
Time Frame: 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 Outcomes
- Sensory block duration(0 - 48 hours after block)
- Analgesic block duration(0 - 48 hours after block)
- Sensory and motor block score(0 - 60 minutes after block)
- Block onset time(0 - 60 minutes after block)
- Incidence of successful block(0 - 60 minutes after block)
- Incidence of failed block(0 - 60 minutes after block)
- Incidence of anesthetic block(60 to 120 minutes after the ending time of local anesthetic injection)
- Procedural pain(Immediately after nerve block)
- Image time(2 hours before surgery)
- Needle time(2 hours before surgery)
- Block performance time(2 hours before surgery)
- Rate of diaphragmatic paresis(From 60 minutes after block to the end of the surgery)
- Duration of surgery(3 hours after skin incision)
- Number of patients requiring general anesthesia(60 to 120 minutes after the ending time of local anesthetic injection)
- Rate of diaphragmatic paralysis(From 60 minutes after block to the end of the surgery)
- Length of PACU stay(3 hours after the end of the surgery)
- Diaphragmatic function(From arrival to the pre-anesthesia unit to the end of surgery)
- Incidence of rebound pain(24 hours after the block wears off)
- Pain score in the post-anesthesia care unit (PACU)(3 hours after the end of the surgery)
- Incidence of nerve block side effects(From skin anesthesia to 60 minutes after the nerve block)
- Postoperative complications(7 days after surgery)
Study Sites (1)
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