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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02698995
Enrollment
180
Registered
2016-03-04
Start date
2015-11-30
Completion date
2017-02-28
Last updated
2020-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

DRUGDexamethasone

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

DRUGRopivacaine

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

DRUGParacetamol

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

DRUGMorphine

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

DRUGLidocaine

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

Sponsors

Foisor Orthopedics Clinical Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensory block durationFirst 24 hoursThe time in minutes measured between VIB block to first analgetic request

Secondary

MeasureTime frameDescription
Glycemic variations at 4 hours post-VIB blockFirst 4 hours postoperativelyDetermination of blood sugar level
Number of patients opioid free analgesiaFirst 24 hours postoperativelyNumber of reported patients with no need opioid analgesia
Motor block durationFirst 24 hours postoperativelyThe time in minutes measured between VIB block to complete movement of the hand
Cutaneous temperature ice-probeFirst 24 hours postoperativelyThe cold sensation on ice-probe test to both arms could be the same or burn likely
Total morphine consumption at 24 hoursFirst 24 hours postoperativelyCumulative morphine administration in milligrams
VAS at the block regressionFirst 24 hours postoperativelyVAS evaluation on the VAS scale (0 - no pain, 10 - the worst pain possible )

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026