Perineural Low-dose Dexamethasone Added to Infraclavicular Block Anesthesia

Analgetic Efficiency of Single-shot Perineural Low Dose Dexamethasone Added to Infraclavicular Block Anesthesia for Upper Limb Surgery

Dexamethasone has an evidence-based indication in postoperative emesis prophylaxy and as a antiinflammatory steroid. Although the perineural administration is off-label, several studies recognised its analgetic action as an adjuvant for peripheral nerves blockade, permitting to reduce the concentration of the local anesthetics and extending the sensory and motor block.Questions remain concerning the mechanism of action, optimal dose, the lack/degree of toxicity and the comparison with intravenous administration.The aim of this prospective randomized controlled study is to investigate the efficacy of analgesia with 4 mg or 2 mg Dexamethasone added to a combination of ropivacaine 0,5% and lidocaine 1% in vertical infraclavicular blockade (VIB) anesthesia for upper limb surgery.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Ropivacaine; Drug: Paracetamol; Drug: Morphine; Drug: Lidocaine; Drug: Dexamethasone

Detailed Description

The investigators conducted a prospective randomized controlled study in 150 patients American Society of Anesthesiologists (ASA) score I-III scheduled for upper limb surgery , divided in 3 groups: group A received anesthesia VIB block with ropivacaine 0,5% 100 mg +lidocaine 1%+1 ml saline; group B received VIB block with ropivacaine 0,5% 100 mg +lidocaine 1% + 2 mg dexamethasone; group C received ropivacaine 0,5% 100 mg +lidocaine 1% + 4 mg dexamethasone.The anesthesiologist may use the ultrasound for visual guidance, but should also use the nerve stimulator in order to maintain the homogeneity of the procedure.

Intraoperative sedation was provided with intermittent bolus 10-20 mg IV Propofol. Postoperatively all patients received the same analgetic protocol when Visual Analog Pain Scale (VAS) over 3 with IV Perfalgan and Lornoxicam 8 mg/12 hours for 24 hours. If after 30 minutes VAS is still over 3, a loading dose of morphine 0,05 mg/kg should be administered. At first analgetic request, the nurse conducts an ice-probe test to both arms and will note the answer: same cold, slightly burn, burn, aching with the reason to test the potentially hyperalgesia effect related to ropivacaine. The data recorded are: time to first analgetic use, VAS at block regression, ice-probe test, motor and sensitive block duration, glycemic variations at 4 h, neurological complications immediately after block, total morphine consumption.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 021383
    • Foisor Orthopedic Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I-III,
• BMI<40,
• non-anemic

Exclusion Criteria:

• High risk grade hypertension, chronic renal failure, known allergy to local anesthetic or NSAIDs, chronic treatment with steroids, drugs dependency, history of diabetes mellitus, ulcer or chronic gastritis, infection on the puncture site, chronic obstructive pulmonary disease, neuropathy at the surgical level

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A; VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+1 ml saline=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.	Drug: Ropivacaine; One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation; Other Names: Naropin; Drug: Paracetamol; After the block regression, at the first analgetic request the patients received the same analgesia protocol; Other Names: Perfalgan; Drug: Morphine; After the block regression, at the first analgetic request the patients received the same analgesia protocol; Other Names: Morphine Sulfate ER; Drug: Lidocaine; One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation; Other Names: Xylocaine
Active Comparator: Group B; VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+2 mg dexamethasone=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.	Drug: Ropivacaine; One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation; Other Names: Naropin; Drug: Paracetamol; After the block regression, at the first analgetic request the patients received the same analgesia protocol; Other Names: Perfalgan; Drug: Morphine; After the block regression, at the first analgetic request the patients received the same analgesia protocol; Other Names: Morphine Sulfate ER; Drug: Lidocaine; One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation; Other Names: Xylocaine; Drug: Dexamethasone; One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation; Other Names: Decadron
Active Comparator: Group C; VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+4 mg dexamethasone=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.	Drug: Ropivacaine; One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation; Other Names: Naropin; Drug: Paracetamol; After the block regression, at the first analgetic request the patients received the same analgesia protocol; Other Names: Perfalgan; Drug: Morphine; After the block regression, at the first analgetic request the patients received the same analgesia protocol; Other Names: Morphine Sulfate ER; Drug: Lidocaine; One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation; Other Names: Xylocaine; Drug: Dexamethasone; One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation; Other Names: Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory block duration	The time in minutes measured between VIB block to first analgetic request	First 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor block duration	The time in minutes measured between VIB block to complete movement of the hand	First 24 hours postoperatively
Glycemic variations at 4 hours post-VIB block	Determination of blood sugar level	First 4 hours postoperatively
Number of patients opioid free analgesia	Number of reported patients with no need opioid analgesia	First 24 hours postoperatively
VAS at the block regression	VAS evaluation on the VAS scale (0 - no pain, 10 - the worst pain possible )	First 24 hours postoperatively
Cutaneous temperature ice-probe	The cold sensation on ice-probe test to both arms could be the same or burn likely	First 24 hours postoperatively
Total morphine consumption at 24 hours	Cumulative morphine administration in milligrams	First 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Foisor Orthopedics Clinical Hospital
• Investigators: Study Director: Ioan Cristian Stoica, MD Prof, Foisor Orthopedics Clinical Hospital

Publications and helpful links

General Publications

• Huynh TM, Marret E, Bonnet F. Combination of dexamethasone and local anaesthetic solution in peripheral nerve blocks: A meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2015 Nov;32(11):751-8. doi: 10.1097/EJA.0000000000000248.
• Williams BA, Hough KA, Tsui BY, Ibinson JW, Gold MS, Gebhart GF. Neurotoxicity of adjuvants used in perineural anesthesia and analgesia in comparison with ropivacaine. Reg Anesth Pain Med. 2011 May-Jun;36(3):225-30. doi: 10.1097/AAP.0b013e3182176f70.
• Kalichman MW, Powell HC, Myers RR. Pathology of local anesthetic-induced nerve injury. Acta Neuropathol. 1988;75(6):583-9. doi: 10.1007/BF00686203.
• Myers RR, Kalichman MW, Reisner LS, Powell HC. Neurotoxicity of local anesthetics: altered perineurial permeability, edema, and nerve fiber injury. Anesthesiology. 1986 Jan;64(1):29-35.
• Zink W, Graf BM. The toxicity of local anesthetics: the place of ropivacaine and levobupivacaine. Curr Opin Anaesthesiol. 2008 Oct;21(5):645-50. doi: 10.1097/ACO.0b013e32830c214c.
• Kawanishi R, Yamamoto K, Tobetto Y, Nomura K, Kato M, Go R, Tsutsumi YM, Tanaka K, Takeda Y. Perineural but not systemic low-dose dexamethasone prolongs the duration of interscalene block with ropivacaine: a prospective randomized trial. Local Reg Anesth. 2014 Apr 5;7:5-9. doi: 10.2147/LRA.S59158. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: February 19, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antipyretics; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Dexamethasone; Lidocaine; Acetaminophen; Ropivacaine; Morphine
• Other Study ID Numbers: ID AN-002-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO