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

NCT ID: NCT04988776

Last Updated: 2021-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2021-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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 ) .

Group Type: ACTIVE_COMPARATOR

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 Type: 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 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 )

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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 )

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

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

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 )

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mamdoh Elsayed Lotfy

UNKNOWN

Sponsor Role: collaborator

amany aly sultan

UNKNOWN

Sponsor Role: collaborator

reem gaber abdel-mageed

UNKNOWN

Sponsor Role: collaborator

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

ashraf magdy eskandr

assistant professor of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

reem abdel-mageed, MBBCh

Role: PRINCIPAL_INVESTIGATOR

resident of anesthesia, menoufia university hospitals

Locations

Ashraf Magdy Eskandr

Shibīn al Kawm, Menoufia, Egypt

Countries

Egypt

Other Identifiers

PECS II versus ICBN block

Identifier Type: -

Identifier Source: org_study_id