Comparative Study Between Single , Intra- Cluster and Double-injection Ultrasound-guided Supraclavicular Block of Brachial Plexus

NCT03188939 | Unknown Phase 4

• 1 other identifier: N-34-2017
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Supraclavicular block of brachial plexus is a type of regional anesthesia sometimes employed as an alternative to general anesthesia for surgery of the forearm. Many approaches have been described for ultrasound-guided supraclavicular block of the brachial plexus , Double- injection technique , single-injection and intra- cluster-injection technique. In intra- cluster-injection technique.The comparison between the 3 techniques may allow detecting the most beneficial one. the investigators hypothesized that intra-cluster-injection technique will be associated with more rapid onset, longer duration and the least complications. (because the trunks and divisions of the brachial plexus are relatively close as they travel over the first rib, the onset and quality of anesthesia will be faster and complete) Methods : This study will be conducted at kasr al ainy Hospital Cairo university After obtaining ethics committee approval and written informed consent 36 patients (who will undergo surgery for forearm)included in the study classified into three groups Gs single injection technique ,Gic intra- cluster injection technique, Gd double injection technique After block will be done, a second investigator will examine the patient for sensory and motor block (every 10 minutes for 30 minutes) and for occurrence of complications. The patient will be ready for surgery when the score ≥14 point. At this point the onset will be determined and so the patient can be transferred to the operating room . If the patient experienced anxiety, propofol infusion (80-250 ug/kg/min) can be started. If the patient experienced pain during surgery the block considered failed and induction of general anesthesia should be started. After end of the surgery the second investigator will continue to assess the patient for post operative pain every one hour for 24 hours to determine duration of the block.

Conditions

Regional Anesthesia Morbidity

Outcome Measures

Primary Outcomes (1)

• onset of the block onset of anesthesia ( time in minutes from introduction of needle to appearance of 14 point score for motor and sensory block ) onset of the block

  time in minutes from introduction of needle to appearance of 14 point score for motor and sensory block )

  from 0- 25 minutes after complete injectio

Secondary Outcomes (1)

• Duration of the block

  25 minutes after injection till 6 hours post oprative

Other Outcomes (2)

• Complications

  from injection till 24 hours postoprative

• Time of first postoperative rescue analgesic

  from injection till 24 hours postoprative

Study Arms (3)

G s

ACTIVE COMPARATOR

20 guage 10cm block needle inserted in the supraclavicular fossa guided by portable ultrasound machine using in plane method and lateral to medial direction, local anesthetic (30 ml bupivacaine) is injected at the point where the subclavian artery meets the first rib

Procedure: single injection supraclavicular brachial pleuxus block

G ic

ACTIVE COMPARATOR

20 guage 10cm block needle inserted in the supraclavicular fossa guided by portable ultrasound machine using in plane method and lateral to medial direction,the local anesthetic(30 ml bupivacaine) is injected inside main and satellite neural cluster.( Circumferential administration of local anesthetic rather than creating a single point injection )

Procedure: intracluster injection supraclavicular brachial pieuxus block

G d

ACTIVE COMPARATOR

20 guage 10cm block needle inserted in the supraclavicular fossa guided by portable ultrasound machine using in plane method and lateral to medial direction,half the volume of local anesthetic(15 ml bupivacaine) is injected at intersection of first rib and subclavian artery and another half(15 ml bupivacaine) is injected supero- lateral to subclavian artery to assure spread of the local anesthetic solution in all planes containing brachial plexus

Procedure: double injection supraclavicular brachial pleuxus block

Interventions

single injection supraclavicular brachial pleuxus block PROCEDURE

the investigator will prepare 20 gauge 10cm block needle and portable ultrasound machine , In single-injection technique using in plane method and lateral to medial direction, local anesthetic is injected at the point where the subclavian artery meets the first rib.

G s

intracluster injection supraclavicular brachial pieuxus block PROCEDURE

the investigator will prepare 20 gauge 10cm block needle and portable ultrasound machine (Siemens ACUSON X300 Ultrasound System with linear probe 8-14 MHZ).using in plane method and lateral to medial direction , the local anesthetic(30 ml bupivacaine) is injected inside main and satellite neural cluster.( Circumferential administration of local anesthetic rather than creating a single point injection )

G ic

double injection supraclavicular brachial pleuxus block PROCEDURE

the investigator will prepare 20 gauge 10cm block needle and portable ultrasound machine (Siemens ACUSON X300 Ultrasound System with linear probe 8-14 MHZ).using in plane method and lateral to medial direction , half the volume of local anesthetic(15 ml bupivacaine) is injected at intersection of first rib and subclavian artery and another half(15 ml bupivacaine) is injected supero- lateral to subclavian artery to assure spread of the local anesthetic solution in all planes containing brachial plexus

G d

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ( 18 -60 years)
• ASA l \& ASA II
• Body mass index(20-35 Kg/m2)

You may not qualify if:

• Pre-existing neuropathy
• ASA lll \& ASA lV
• Previous operation in supraclavicular fossa
• Coagulopathy
• Allergy to local anesthetic
• Pregnancy
• Inability to visualize the brachial plexus during ultrasound scanning.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine CAIRO UNIVERISTY

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: For the 3 techniques , we will prepare 20 gauge 10cm block needle and portable ultrasound machine , In single-injection technique using in plane method and lateral to medial direction, local anesthetic is injected at the point where the subclavian artery meets the first rib. In intra- cluster-injection technique using in plane method and lateral to medial direction , the local anesthetic is injected inside main and satellite neural cluster. In double-injection technique using in plane method and lateral to medial direction half the volume of local anesthetic is injected at intersection of first rib and subclavian artery and another half is injected supero- lateral to subclavian artery to assure spread of the local anesthetic solution in all planes containing brachial plexus.

Study Record Dates

• First Submitted: June 10, 2017
• First Posted: June 16, 2017
• Study Start: July 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

EG (1)