Clinical trial NCT04284007: Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine
Official title: Intravenous Versus Perineural Dexamethasone in Interscalene Nerve Block With Levobupivacaine for Shoulder and Upper Arm Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Interscalene brachial plexus block can be used as an additive to general anaesthesia or as the primary anaesthetic for shoulder surgeries for pain management.

The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.

Detailed description: Dexamethasone had been shown to prolong the duration of postoperative analgesia when given as an adjuvant for peripheral nerve blocks.

The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.

The study hypothesized that adding perineural dexamethasone to levobupivacaine in ultrasound guided interscalene block may be more superior to adding intravenous dexamethasone to levobupivacaine and levobupivacaine alone in shoulder and upper arm surgeries as regard analgesic effect, duration of analgesia and hemodynamic stability.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status grade I and grade II.

Exclusion Criteria:

* Patient refusal.
* Neuromuscular diseases (as myopathies, myasthenia gravies, ......)
* Hematological diseases, bleeding or coagulation abnormality.
* Psychiatric diseases.
* Local skin infection
* Sepsis at site of the block.
* Known intolerance to the study drugs.
* Body Mass Index \> 40 Kg/m2
* contralateral phrenic palsy
* pneumothorax
* pneumectomy
* severe COPD

Primary outcomes:
measure: Duration of postoperative analgesia
timeFrame: for 24 hour postoperatively
Secondary outcomes:
measure: Onset of Sensory block
timeFrame: For 30 min after injecting local anesthetic
measure: Duration of sensory block
timeFrame: within 24 hours after the surgery.
measure: Onset time of motor block
timeFrame: For 30 min after injecting local anesthic
measure: Duration of motor block
timeFrame: within 24 hours after the surge
measure: Intraoperative Heart rate changes
timeFrame: For 3 hours after surgery
measure: Intraoperative Mean arterial blood pressure changes
timeFrame: For 3 hours after surgery
measure: Intraoperative analgesic consumption
timeFrame: For 3 hours after surgery
measure: Postoperative heart rate changes
timeFrame: For one hour after admission to the postoperative anesthesia care unit
measure: Postoperative Mean arterial blood pressure changes
timeFrame: For one hour after admission to the postoperative anesthesia care unit
measure: Postoperative peripheral oxygen saturation changes
timeFrame: For one hour after admission to the postoperative anesthesia care unit
measure: Pain score
timeFrame: Pain after surgery will be assessed using VAS at 1,2,6,12 and 24 hours.
measure: Total analgesic need and the onset of first intravenous analgesia
timeFrame: After transportation of the patient from PACU up to 24 hours postoperative.
measure: Patient satisfaction: 2-point scale
timeFrame: first 24 hours postoperatively
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University
state: Dakhlia
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Nahla S El-Ebahnsawy, MD
role: STUDY_CHAIR
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
name: Hazem E Moawed, MD
role: STUDY_DIRECTOR
References: