Perineural Low-dose Dexamethasone Added to Infraclavicular Block Anesthesia

NCT ID: NCT02698995

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-02-28

Brief 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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Ropivacaine

Intervention Type: DRUG

One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

Paracetamol

Intervention Type: DRUG

After the block regression, at the first analgetic request the patients received the same analgesia protocol

Morphine

Intervention Type: DRUG

After the block regression, at the first analgetic request the patients received the same analgesia protocol

Lidocaine

Intervention Type: DRUG

One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

Ropivacaine

Intervention Type: DRUG

One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

Paracetamol

Intervention Type: DRUG

After the block regression, at the first analgetic request the patients received the same analgesia protocol

Morphine

Intervention Type: DRUG

After the block regression, at the first analgetic request the patients received the same analgesia protocol

Lidocaine

Intervention Type: DRUG

One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

Ropivacaine

Intervention Type: DRUG

One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

Paracetamol

Intervention Type: DRUG

After the block regression, at the first analgetic request the patients received the same analgesia protocol

Morphine

Intervention Type: DRUG

After the block regression, at the first analgetic request the patients received the same analgesia protocol

Lidocaine

Intervention Type: DRUG

One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

Interventions

Dexamethasone

One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

Intervention Type: DRUG

Ropivacaine

One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

Intervention Type: DRUG

Paracetamol

After the block regression, at the first analgetic request the patients received the same analgesia protocol

Intervention Type: DRUG

Morphine

After the block regression, at the first analgetic request the patients received the same analgesia protocol

Intervention Type: DRUG

Lidocaine

One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

Intervention Type: DRUG

Other Intervention Names

Decadron; Naropin; Perfalgan; Morphine Sulfate ER; Xylocaine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foisor Orthopedics Clinical Hospital

OTHER

Sponsor Role: lead

Responsible Party

Munteanu Ana Maria, MD, PhD

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ioan Cristian Stoica, MD Prof

Role: STUDY_DIRECTOR

Foisor Orthopedics Clinical Hospital

Locations

Foisor Orthopedic Clinical Hospital

Bucharest, , Romania

Countries

Romania

References

Kalichman MW, Powell HC, Myers RR. Pathology of local anesthetic-induced nerve injury. Acta Neuropathol. 1988;75(6):583-9. doi: 10.1007/BF00686203.

Reference Type: RESULT

PMID: 3376761 (View on PubMed)

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.

Reference Type: RESULT

PMID: 3942334 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18784493 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21519308 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25774458 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24817819 (View on PubMed)

Other Identifiers

ID AN-002-14

Identifier Type: -

Identifier Source: org_study_id