Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03188939
Recruitment Status : Unknown
Verified June 2017 by Sherin Refaat, Cairo University.
Recruitment status was:  Enrolling by invitation
First Posted : June 16, 2017
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Sherin Refaat, Cairo University

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.


Condition or disease Intervention/treatment Phase
Regional Anesthesia Morbidity Procedure: single injection supraclavicular brachial pleuxus block Procedure: intracluster injection supraclavicular brachial pieuxus block Procedure: double injection supraclavicular brachial pleuxus block Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Comparative Study Between Single-injection , Intra- Cluster -Injection and Double-injection Ultrasound-guided Supraclavicular Block of Brachial Plexus
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: G s
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
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.

Active Comparator: G ic
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
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 )

Active Comparator: G d
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
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




Primary Outcome Measures :
  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 Frame: from 0- 25 minutes after complete injectio ]
    time in minutes from introduction of needle to appearance of 14 point score for motor and sensory block )


Secondary Outcome Measures :
  1. Duration of the block [ Time Frame: 25 minutes after injection till 6 hours post oprative ]
    from onset to appearance of pain in surgery site


Other Outcome Measures:
  1. Complications [ Time Frame: from injection till 24 hours postoprative ]
    intravascular injection , pneumothorax or horner syndrome

  2. Time of first postoperative rescue analgesic [ Time Frame: from injection till 24 hours postoprative ]
    the first time the patient ask for analgesia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ( 18 -60 years)
  2. ASA l & ASA II
  3. Body mass index(20-35 Kg/m2)

Exclusion Criteria:

  1. Pre-existing neuropathy
  2. ASA lll & ASA lV
  3. Previous operation in supraclavicular fossa
  4. Coagulopathy
  5. Allergy to local anesthetic
  6. Pregnancy
  7. Inability to visualize the brachial plexus during ultrasound scanning.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188939


Locations
Layout table for location information
Egypt
Faculty of medicine CAIRO UNIVERISTY
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Layout table for additonal information
Responsible Party: Sherin Refaat, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03188939    
Other Study ID Numbers: N-34-2017
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No