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

NCT04988776 | Completed Phase 1

• 1 other identifier: PECS II versus ICBN block
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Analgesia; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• intraoperative local anesthetic requirement

  volume of local anesthetic

  1-2 hours after surgery start

Secondary Outcomes (1)

• postoperative pain

  24 hours after end of surgery

Study Arms (2)

group A

ACTIVE COMPARATOR

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

group B

ACTIVE COMPARATOR

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

Interventions

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

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 ) .

group A

ultrasound-guided pectoral nerves block type II supplemental to supraclavicular block OTHER

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 )

group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead
• Mamdoh Elsayed Lotfy: collaborator
• amany aly sultan: collaborator
• reem gaber abdel-mageed: collaborator

Study Sites (1)

Ashraf Magdy Eskandr

Shibīn al Kawm, Menoufia, 32951, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• reem abdel-mageed, MBBCh

  resident of anesthesia, menoufia university hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: August 3, 2021
• Study Start: February 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: for 1 year after the end of the study
• Access Criteria: study protocol

Locations

EG (1)