Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine

Sponsor

Mansoura University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04284007

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain	Drug: Perineural levobupivacaine Drug: Perineural dexamethasone in addition to levobupivacaine Drug: Intravenous dexamethasone with perineural levobupivacaine	N/A

Detailed Description

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

Double-blind

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 2, 2019

Anticipated Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Perineural levobupivacaine with intravenous saline Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline.	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.
Experimental: Perineural dexamethasone in addition to levobupivacaine Patients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline.	Drug: 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.
Experimental: Intravenous dexamethasone with perineural levobupivacaine Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone.	Drug: 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.

Arm

Intervention/Treatment

Active Comparator: Perineural levobupivacaine with intravenous saline

Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline.

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.

Experimental: Perineural dexamethasone in addition to levobupivacaine

Patients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline.

Drug: 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.

Experimental: Intravenous dexamethasone with perineural levobupivacaine

Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone.

Drug: 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.

Outcome Measures

Primary Outcome Measures

Duration of postoperative analgesia [for 24 hour postoperatively]
as measured by time to first analgesic requirement.

Secondary Outcome Measures

Onset of Sensory block [For 30 min after injecting local anesthetic]
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).
Duration of sensory block [within 24 hours after the surgery.]
defined as the time interval between complete sensory block (score 2) and complete resolution of anaesthesia on all nerves (score 0)
Onset time of motor block [For 30 min after injecting local anesthic]
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).
Duration of motor block [within 24 hours after the surge]
defined as the time interval between complete motor block (score 2) and complete recovery of motor function of the arm (score 0).
Intraoperative Heart rate changes [For 3 hours after surgery]
Heart rate changes
Intraoperative Mean arterial blood pressure changes [For 3 hours after surgery]
Mean arterial blood pressure changes
Intraoperative analgesic consumption [For 3 hours after surgery]
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)
Postoperative heart rate changes [For one hour after admission to the postoperative anesthesia care unit]
Postoperative Mean arterial blood pressure changes [For one hour after admission to the postoperative anesthesia care unit]
Postoperative peripheral oxygen saturation changes [For one hour after admission to the postoperative anesthesia care unit]
Pain score [Pain after surgery will be assessed using VAS at 1,2,6,12 and 24 hours.]
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)
Total analgesic need and the onset of first intravenous analgesia [After transportation of the patient from PACU up to 24 hours postoperative.]
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.
Patient satisfaction: 2-point scale [first 24 hours postoperatively]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University	Mansourah	Dakhlia	Egypt	050

Sponsors and Collaborators

Mansoura University

Investigators

Study Chair: Nahla S El-Ebahnsawy, MD, Professor of Anesthesia and Surgical Intensive Care
Study Director: Hazem E Moawed, MD, Assistant Professor of Anesthesia and Surgical Intensive Care