Skip to main content
OpenTrials
Completed

NCT Number: NCT02698995

Perineural Low-dose Dexamethasone Added to Infraclavicular Block Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Foisor Orthopedic Clinical Hospital

Bucharest, 021383, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Other names: Decadron

Ropivacaine

Drug

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

Other names: Naropin

Paracetamol

Drug

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

Other names: Perfalgan

Morphine

Drug

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

Other names: Morphine Sulfate ER

Lidocaine

Drug

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

Other names: Xylocaine

Primary outcomes

  1. Sensory block duration

    Time frame: First 24 hours

    The time in minutes measured between VIB block to first analgetic request

Secondary outcomes

  1. Motor block duration

    Time frame: First 24 hours postoperatively

    The time in minutes measured between VIB block to complete movement of the hand

  2. Glycemic variations at 4 hours post-VIB block

    Time frame: First 4 hours postoperatively

    Determination of blood sugar level

  3. Number of patients opioid free analgesia

    Time frame: First 24 hours postoperatively

    Number of reported patients with no need opioid analgesia

  4. VAS at the block regression

    Time frame: First 24 hours postoperatively

    VAS evaluation on the VAS scale (0 - no pain, 10 - the worst pain possible )

  5. Cutaneous temperature ice-probe

    Time frame: First 24 hours postoperatively

    The cold sensation on ice-probe test to both arms could be the same or burn likely

  6. Total morphine consumption at 24 hours

    Time frame: First 24 hours postoperatively

    Cumulative morphine administration in milligrams

Sponsors and collaborators

Lead sponsor

Foisor Orthopedics Clinical Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 4, 2016
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.