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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Intraoperative Analgesia
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 32951
      • Ashraf Magdy Eskandr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative local anesthetic requirement	volume of local anesthetic	1-2 hours after surgery start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	Visual analogue score (0-10) where 0=no pain and 10=the worst pain	24 hours after end of surgery

Collaborators and Investigators

• Sponsor: Menoufia University
• Collaborators: Mamdoh Elsayed Lotfy; amany aly sultan; reem gaber abdel-mageed
• Investigators: Principal Investigator: reem abdel-mageed, MBBCh, resident of anesthesia, menoufia university hospitals

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: July 25, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: PECS II versus ICBN block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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