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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04988776
Other study ID # PECS II versus ICBN block
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date February 1, 2020
Est. completion date February 28, 2021

Study information

Verified date September 2021
Source Menoufia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 28, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

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 ) .
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 )

Locations

Country Name City State
Egypt Ashraf Magdy Eskandr Shibin Al Kawm Menoufia

Sponsors (4)

Lead Sponsor Collaborator
Menoufia University amany aly sultan, Mamdoh Elsayed Lotfy, reem gaber abdel-mageed

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary intraoperative local anesthetic requirement volume of local anesthetic 1-2 hours after surgery start
Secondary postoperative pain Visual analogue score (0-10) where 0=no pain and 10=the worst pain 24 hours after end of surgery
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