Perineural Low-dose Dexamethasone Added to Infraclavicular Block Anesthesia

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698995
• Other study ID #: ID AN-002-14
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: February 2017

Study information

• Verified date: August 2020
• Source: Foisor Orthopedics Clinical Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexamethasone
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
• Ropivacaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
• Paracetamol
After the block regression, at the first analgetic request the patients received the same analgesia protocol
• Morphine
After the block regression, at the first analgetic request the patients received the same analgesia protocol
• Lidocaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

Locations

Country	Name	City	State
Romania	Foisor Orthopedic Clinical Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Foisor Orthopedics Clinical Hospital

Country where clinical trial is conducted

Romania, 

References & Publications (6)

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. Review. — View Citation

Kalichman MW, Powell HC, Myers RR. Pathology of local anesthetic-induced nerve injury. Acta Neuropathol. 1988;75(6):583-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory block duration	The time in minutes measured between VIB block to first analgetic request	First 24 hours
Secondary	Motor block duration	The time in minutes measured between VIB block to complete movement of the hand	First 24 hours postoperatively
Secondary	Glycemic variations at 4 hours post-VIB block	Determination of blood sugar level	First 4 hours postoperatively
Secondary	Number of patients opioid free analgesia	Number of reported patients with no need opioid analgesia	First 24 hours postoperatively
Secondary	VAS at the block regression	VAS evaluation on the VAS scale (0 - no pain, 10 - the worst pain possible )	First 24 hours postoperatively
Secondary	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
Secondary	Total morphine consumption at 24 hours	Cumulative morphine administration in milligrams	First 24 hours postoperatively