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PECS II Versus ICBN Block Plus SCNB for AV Fistula Creation in CRF Patients

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ClinicalTrials.gov Identifier: NCT04988776
Recruitment Status : Completed
First Posted : August 3, 2021
Last Update Posted : August 3, 2021
Sponsor:
Collaborators:
Mamdoh Elsayed Lotfy
amany aly sultan
reem gaber abdel-mageed
Information provided by (Responsible Party):
ashraf magdy eskandr, Menoufia University

Brief Summary:
Brachial plexus block (BPB) is often utilized for proximal arm arteriovenous access creation. However, the medial upper arm and axilla are often inadequately anesthetised, as Intercostobrachial nerve (which provides sensory supply to the axilla, upper medial arm and a small area at the upper lateral chest) is not a component of the brachial plexus. This requires repeated, intraoperative local anesthetic (LA) supplementation up to conversion into GA. The intercostobrachial nerve (ICBN) is a pure sensory nerve that arises primarily from the second intercostal nerve (T2) with occasional contribution from T3. Therefore, It is not a component of the brachial plexus and is not anesthetized by brachial plexus blockade. The ICBN can be blocked together with other nerves, such as the pectoral, intercostal, and long thoracic nerves in a recently described technique named pectoral nerves block type II (PECS II ).In this thesis, we compare between the use of the PECS II block and ICBN block as a supplement to supraclavicular brachial plexus block for providing complete anesthesia of the upper arm for fistula creation surgery.

Condition or disease Intervention/treatment Phase
Intraoperative Analgesia Postoperative Pain Other: ultrasUltrasound-guided Intercostobrachial nerve block supplemental to supraclavicular block with 30 ml 0.25% bupivacaine (15 ml 0.5% bupivacaine will be added to 15 m Other: ultrasound-guided pectoral nerves block type II supplemental to supraclavicular block Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison Between Ultrasound-guided Pectoral Nerves Block Type II and Intercostobrachial Nerve Block as a Supplement to Supraclavicular Block for Anesthesia of Proximal Arteriovenous Access in End-stage Renal Disease Patients
Actual Study Start Date : February 1, 2020
Actual Primary Completion Date : February 28, 2021
Actual Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: group A
Patients received ultrasound-guided Intercostobrachial nerve block with 10 ml 0.25% bupivacaine (5 ml 0.5% bupivacaine will be added to 5ml 0.9% normal saline ) supplemental to supraclavicular block with 30 ml 0.25% bupivacaine (15 ml 0.5% bupivacaine will be added to 15 ml of 0.9 %Nacl ) .
Other: ultrasUltrasound-guided Intercostobrachial nerve block supplemental to supraclavicular block with 30 ml 0.25% bupivacaine (15 ml 0.5% bupivacaine will be added to 15 m
patients recieved ultrasound-guided Intercostobrachial nerve block with 10 ml 0.25% bupivacaine (5 ml 0.5% bupivacaine will be added to 5ml 0.9% normal saline ) supplemental to supraclavicular block with 30 ml 0.25% bupivacaine (15 ml 0.5% bupivacaine will be added to 15 ml of 0.9 %Nacl ) .

Active Comparator: group B
patients received ultrasound-guided pectoral nerves block type II with 10 ml 0.25% bupivacaine (5 ml 0.5% bupivacaine will be added to 5ml 0.9% normal saline ) supplemental to supraclavicular block with 30 ml 0.25% bupivacaine (15 ml 0.5% bupivacaine will be added to 15 ml of 0.9 %Nacl )
Other: ultrasound-guided pectoral nerves block type II supplemental to supraclavicular block
Patients received ultrasound-guided pectoral nerves block type II with 10 ml 0.25% bupivacaine (5 ml 0.5% bupivacaine will be added to 5ml 0.9% normal saline ) supplemental to supraclavicular block with 30 ml 0.25% bupivacaine (15 ml 0.5% bupivacaine will be added to 15 ml of 0.9 %Nacl )




Primary Outcome Measures :
  1. intraoperative local anesthetic requirement [ Time Frame: 1-2 hours after surgery start ]
    volume of local anesthetic


Secondary Outcome Measures :
  1. postoperative pain [ Time Frame: 24 hours after end of surgery ]
    Visual analogue score



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ESRD patients.
  • Proximal Arm Arteriovenous Access Surgery.
  • Elective or emergency surgery
  • American Society of Anesthesiology (ASA) physical status II to III.

Exclusion Criteria:

  • Inability of the patient to provide informed consent, communicate or cooperate
  • History of allergy to local anesthetics.
  • Preexisting upper limb neurological disease at the side of the surgery.
  • Patients on anticoagulant therapy or with history of coagulopathy.
  • Previous surgery at or near the site of the study.
  • The presence of skin infection at the puncture site.

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): NCT04988776


Locations
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Egypt
Ashraf Magdy Eskandr
Shibīn Al Kawm, Menoufia, Egypt, 32951
Sponsors and Collaborators
Menoufia University
Mamdoh Elsayed Lotfy
amany aly sultan
reem gaber abdel-mageed
Investigators
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Principal Investigator: reem abdel-mageed, MBBCh resident of anesthesia, menoufia university hospitals
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Responsible Party: ashraf magdy eskandr, 3, yassin abd-elghafar st., shibin elkoom, Menoufia University
ClinicalTrials.gov Identifier: NCT04988776    
Other Study ID Numbers: PECS II versus ICBN block
First Posted: August 3, 2021    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be available after end of the study
Supporting Materials: Study Protocol
Time Frame: for 1 year after the end of the study
Access Criteria: study protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents