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

Primary Purpose

Intraoperative Analgesia, Postoperative Pain

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
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
ultrasound-guided pectoral nerves block type II supplemental to supraclavicular block
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intraoperative Analgesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ashraf Magdy Eskandr

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A

group B

Arm Description

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 ) .

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 )

Outcomes

Primary Outcome Measures

intraoperative local anesthetic requirement
volume of local anesthetic

Secondary Outcome Measures

postoperative pain
Visual analogue score (0-10) where 0=no pain and 10=the worst pain

Full Information

First Posted
July 25, 2021
Last Updated
September 17, 2021
Sponsor
Menoufia University
Collaborators
Mamdoh Elsayed Lotfy, amany aly sultan, reem gaber abdel-mageed
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1. Study Identification

Unique Protocol Identification Number
NCT04988776
Brief Title
PECS II Versus ICBN Block Plus SCNB for AV Fistula Creation in CRF Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
Collaborators
Mamdoh Elsayed Lotfy, amany aly sultan, reem gaber abdel-mageed

4. Oversight

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

5. Study Description

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 anesthetized, as the 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, an intraoperative local anesthetic (LA) supplementation up to conversion into GA. The intercostobrachial nerve (ICBN) is a purely 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, investigators compared 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Analgesia, Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
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 ) .
Arm Title
group B
Arm Type
Active Comparator
Arm Description
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 )
Intervention Type
Other
Intervention Name(s)
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
Intervention Description
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 ) .
Intervention Type
Other
Intervention Name(s)
ultrasound-guided pectoral nerves block type II supplemental to supraclavicular block
Intervention Description
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 Measure Information:
Title
intraoperative local anesthetic requirement
Description
volume of local anesthetic
Time Frame
1-2 hours after surgery start
Secondary Outcome Measure Information:
Title
postoperative pain
Description
Visual analogue score (0-10) where 0=no pain and 10=the worst pain
Time Frame
24 hours after end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
reem abdel-mageed, MBBCh
Organizational Affiliation
resident of anesthesia, menoufia university hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ashraf Magdy Eskandr
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
32951
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be available after end of the study
IPD Sharing Time Frame
for 1 year after the end of the study
IPD Sharing Access Criteria
study protocol

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

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