Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine

Shoulder Pain Clinical Trial

Official title:

Intravenous Versus Perineural Dexamethasone in Interscalene Nerve Block With Levobupivacaine for Shoulder and Upper Arm Surgeries

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04284007
• Other study ID #: MFM_IRB, MS.18.03.65 -
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Drug:
• Perineural levobupivacaine
Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.
• Perineural dexamethasone in addition to levobupivacaine
Patients will receive 20 ml of 0.25% levobupivacaine plus 4mg dexamethasone diluted in 2 ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.
• Intravenous dexamethasone with perineural levobupivacaine
Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 4 mg intravenous dexamethasone diluted in 10 ml saline.

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansourah	Dakhlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of postoperative analgesia	as measured by time to first analgesic requirement.	for 24 hour postoperatively
Secondary	Onset of Sensory block	Patients will be closely observed until 30 minutes after the end of local anesthetic injection. Block success will be defined as loss of sensation to pinprick in the C4 and C5 sensory dermatome distribution measured 30 minutes after the end of local anesthetic injection. sensory block will be assessed by pin prick test using a 3point scale: • Grade 0 = Normal sensation.; Grade 1 = loss of sensation to pin prick (analgesia).; Grade 2 = loss of sensation to touch (anaesthesia). Onset time for sensory block will be defined as the time interval between the end of local anaesthesia administration and complete sensory block (score 2).	For 30 min after injecting local anesthetic
Secondary	Duration of sensory block	defined as the time interval between complete sensory block (score 2) and complete resolution of anaesthesia on all nerves (score 0)	within 24 hours after the surgery.
Secondary	Onset time of motor block	Motor block will be determined according to the modified Bromage scale: Grade 0 = Normal motor function with full flexion and extention of elbow.; Grade 1 = Decrease motor power.; Grade 2 = Complete motor block. Onset time of motor block will be defined as the time interval between end of local anaesthetic administration and complete motor block (grade 2).	For 30 min after injecting local anesthic
Secondary	Duration of motor block	defined as the time interval between complete motor block (score 2) and complete recovery of motor function of the arm (score 0).	within 24 hours after the surge
Secondary	Intraoperative Heart rate changes	Heart rate changes	For 3 hours after surgery
Secondary	Intraoperative Mean arterial blood pressure changes	Mean arterial blood pressure changes	For 3 hours after surgery
Secondary	Intraoperative analgesic consumption	the intraoperative analgesic dose consumption would be calculated The investigators can use fentanyl as analgesic if the patient required during the surgery ( 50-100 mic)	For 3 hours after surgery
Secondary	Postoperative heart rate changes		For one hour after admission to the postoperative anesthesia care unit
Secondary	Postoperative Mean arterial blood pressure changes		For one hour after admission to the postoperative anesthesia care unit
Secondary	Postoperative peripheral oxygen saturation changes		For one hour after admission to the postoperative anesthesia care unit
Secondary	Pain score	The VAS is represented with straight line with one end has the anchor " no pain" and it takes 0, while the other end of the line has the anchor " pain as bad as it could be" and it takes 10.; The patient will receive the rescue analgesic when the score is more than 4)	Pain after surgery will be assessed using VAS at 1,2,6,12 and 24 hours.
Secondary	Total analgesic need and the onset of first intravenous analgesia	Total analgesic need to rescue analgesic (pethidine) calculated by mg. And the onset of time for first intravenous analgesia during the 24 hours postoperative by hours.	After transportation of the patient from PACU up to 24 hours postoperative.
Secondary	Patient satisfaction: 2-point scale	concerning the procedure is assessed using a 2-point scale (1= satisfied, I would want the same anesthesia / analgesia method for the next surgery, 2= unsatisfied, I would want a different anesthesia / analgesia method for the next surgery).	first 24 hours postoperatively