Back to resultsAnalgesic Effect of Supraclavicular Block and Interscalene Analgesia Versus an Intercostobrachial Nerve Block Versus PCA in Forearm Surgery
Primary Purpose
Forearm Surgery, US-Guided Supraclavicular Block, Interscalene Analgesia
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
bupivacaine, midazolam
Sponsored by
About this trial
This is an interventional prevention trial for Forearm Surgery focused on measuring Intercostobrachial Nerve Block, PCA with Fentanyl
Eligibility Criteria
Inclusion Criteria: aged more than 18 years, ASAI-III patients scheduled to undergo orthopedic or plastic surgery distal to the elbow with an anticipated tourniquet duration greater than 45 min. desiring regional anesthesia as the primary anesthetic. Exclusion Criteria: Contraindication to regional anesthesia. Allergy to local anesthetics. Primary block failure. If patients desired deep intraoperative sedation. Clinically significant cognitive impairment.
Sites / Locations
- Facualty of Medicine(Damietta), Al Azhar UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
interscalene analgesia (Group ISBPB)
The intercostobrachial nerve block ( Group ICBN)
Patient-Controlled Analgesia (Group PCA)
Arm Description
All patients will receive a supraclavicular block as their primary anesthetic. Brachial plexus blocks will be performed at the supraclavicular fossa using 20 to 30 mL of 0.5% bupivacaine under ultrasound guidance. The C5 to C7 or C5 to C8 nerve roots between the anterior scalene and middle scalene muscles will be visualized in the absence of the subclavian artery and 10 mL 0.125% bupivacaine will be injected around the nerve roots of the brachial plexus. The needle trajectory will be adjusted to facilitate the even distribution of the local anesthetic around each nerve root.
All patients will receive a supraclavicular block as their primary anesthetic. Brachial plexus blocks will be performed at the supraclavicular fossa using 20 to 30 mL of 0.5% bupivacaine under ultrasound guidance. The ICBN block will be performed with 10 mL of 0.5% bupivacaine in the plane deep to the pectoralis minor and/or serratus anterior muscle over the second and third intercostal space.
All patients will receive a supraclavicular block as their primary anesthetic. Brachial plexus blocks will be performed at the supraclavicular fossa using 20 to 30 mL of 0.5% bupivacaine under ultrasound guidance.
Outcomes
Primary Outcome Measures
The incidence of tourniquet pain
The incidence of tourniquet pain will be assessed by the patient's VAS score. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The patient is asked to rate their current level of pain by placing a mark on the line.
Secondary Outcome Measures
Hemodynamics
Hemodynamics up to 2 hours postoperative (heart rate, mean arterial blood pressure. Mean arterial blood pressure and heart rate will be recorded at baseline and every 5 min till the end of the procedure.
The incidence of adverse reactions
The incidence of adverse reactions (Pneumothorax, Horner's syndrome) will be evaluated.
Patients' satisfaction
Patients' satisfaction will be measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05602636
Brief Title
Analgesic Effect of Supraclavicular Block and Interscalene Analgesia Versus an Intercostobrachial Nerve Block Versus PCA in Forearm Surgery
Official Title
Efficacy of Combined US-Guided Supraclavicular Block and Interscalene Analgesia Versus an Intercostobrachial Nerve Block Versus PCA With Fentanyl on Preventing Tourniquet Pain in Forearm Surgery: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The etiology of tourniquet pain is complex, and the study team hypothesizes that blocking with Interscalene brachial plexus block (ISBPB) is more efficient in decreasing the incidence of tourniquet pain in comparison with other techniques.
As there is a paucity of studies that evaluate the effect of intercostobrachial nerve (ICBN) block and ISBPB and Patient-Controlled Analgesia (PCA) with a supraclavicular brachial plexus block (SCBPB) on tourniquet pain in forearm surgery, Therefore, we established this randomized study to compare ISBPB and ICBN and PCA with fentanyl with SCBPB in terms of the incidence and severity of tourniquet pain in patients undergoing forearm surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Forearm Surgery, US-Guided Supraclavicular Block, Interscalene Analgesia, Tourniquet Pain
Keywords
Intercostobrachial Nerve Block, PCA with Fentanyl
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interscalene analgesia (Group ISBPB)
Arm Type
Active Comparator
Arm Description
All patients will receive a supraclavicular block as their primary anesthetic. Brachial plexus blocks will be performed at the supraclavicular fossa using 20 to 30 mL of 0.5% bupivacaine under ultrasound guidance.
The C5 to C7 or C5 to C8 nerve roots between the anterior scalene and middle scalene muscles will be visualized in the absence of the subclavian artery and 10 mL 0.125% bupivacaine will be injected around the nerve roots of the brachial plexus. The needle trajectory will be adjusted to facilitate the even distribution of the local anesthetic around each nerve root.
Arm Title
The intercostobrachial nerve block ( Group ICBN)
Arm Type
Active Comparator
Arm Description
All patients will receive a supraclavicular block as their primary anesthetic. Brachial plexus blocks will be performed at the supraclavicular fossa using 20 to 30 mL of 0.5% bupivacaine under ultrasound guidance.
The ICBN block will be performed with 10 mL of 0.5% bupivacaine in the plane deep to the pectoralis minor and/or serratus anterior muscle over the second and third intercostal space.
Arm Title
Patient-Controlled Analgesia (Group PCA)
Arm Type
Active Comparator
Arm Description
All patients will receive a supraclavicular block as their primary anesthetic. Brachial plexus blocks will be performed at the supraclavicular fossa using 20 to 30 mL of 0.5% bupivacaine under ultrasound guidance.
Intervention Type
Drug
Intervention Name(s)
bupivacaine, midazolam
Intervention Description
Patients will be provided with midazolam (up to 2 mg) if requested. No opioids will be administered before the incision. At the first patient complaint of pain, the intraoperative anesthesia team will document the quality and location of pain, and 50 microgram of fentanyl will be administered if the patient requested it or pain score more than 3
Primary Outcome Measure Information:
Title
The incidence of tourniquet pain
Description
The incidence of tourniquet pain will be assessed by the patient's VAS score. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The patient is asked to rate their current level of pain by placing a mark on the line.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Hemodynamics
Description
Hemodynamics up to 2 hours postoperative (heart rate, mean arterial blood pressure. Mean arterial blood pressure and heart rate will be recorded at baseline and every 5 min till the end of the procedure.
Time Frame
2 hours
Title
The incidence of adverse reactions
Description
The incidence of adverse reactions (Pneumothorax, Horner's syndrome) will be evaluated.
Time Frame
2 hours
Title
Patients' satisfaction
Description
Patients' satisfaction will be measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged more than 18 years,
ASAI-III patients
scheduled to undergo orthopedic or plastic surgery distal to the elbow with an anticipated tourniquet duration greater than 45 min.
desiring regional anesthesia as the primary anesthetic.
Exclusion Criteria:
Contraindication to regional anesthesia.
Allergy to local anesthetics.
Primary block failure.
If patients desired deep intraoperative sedation.
Clinically significant cognitive impairment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neveen A. Kohaf, Ph.D
Phone
+201069482380
Email
nevenabdo@azhar.edu.eg
Facility Information:
Facility Name
Facualty of Medicine(Damietta), Al Azhar University
City
Damietta
ZIP/Postal Code
34711
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neveen A. Kohaf, Ph.D
Phone
01069482380
Email
nevenabdo@azhar.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data can be shared with a reasonable request from the corresponding auther
Learn more about this trial
Analgesic Effect of Supraclavicular Block and Interscalene Analgesia Versus an Intercostobrachial Nerve Block Versus PCA in Forearm Surgery
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