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Evaluating the Analgesic Efficacy of Combined Individual Nerve Block in Comparison to Interscalene Nerve Block

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
interscalene block
selective nerve block
bupivacaine
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA I, II
  • scheduled for arthroscopic assisted adhesiolysis

Exclusion Criteria:

  • restrictive lung disease,
  • refusal of the procedure,
  • coagulopathy,
  • allergy to any of the used medications

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A: receive ultrasound-guided interscalene block

group B: receive ultrasound-guided selective nerve block

Arm Description

The patient will be put in the supine position, with the arm adducted a high-frequency linear ultrasound probe is oriented transversely across the lateral neck. When visualizing the ''stoplight sign,''15 to 30 mL of 0.25% bupivacaine consistent with the overall local anaesthetic dosing of less than 2.5 mg/kg. will be injected with low pressures to avoid intraneural injection.

The patient will be put in the sitting position, a linear 38-mm high frequency 10-12 MHz transducer will be placed first on the scapula to obtain a view of the suprascapular nerve a 22 G, 8 cm needle will be advanced in-plane and a total of 5-8 mL of 0.25% bupivacaine is injected then the arm adducted the linear probe will be placed at the junction of the pectoralis major muscle and the biceps muscle such that the axillary artery will be visualized in cross-section The probe will be moved towards the biceps muscle (laterally) until the musculocutaneous nerve is visualized and8 ml of 0.25% bupivacaine will be injected

Outcomes

Primary Outcome Measures

the duration of postoperative analgesia
postoperative pain by visual analogue scale (VAS) a 10 point scale where 1 means no pain and 10 means worst pain ever

Secondary Outcome Measures

range of motion of the operated shoulder
free or limited

Full Information

First Posted
January 7, 2021
Last Updated
February 11, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04709250
Brief Title
Evaluating the Analgesic Efficacy of Combined Individual Nerve Block in Comparison to Interscalene Nerve Block
Official Title
Evaluating the Analgesic Efficacy of Combined Individual Nerve Block in Comparison to Interscalene Nerve Block in Patients Undergoing Shoulder Arthroscopic Assisted Adhesiolysis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams 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
Patients undergoing total shoulder arthroscopic adhesiolysis may experience severe postoperative pain. Inadequate pain management can result in unfavourable hospital outcomes and the development of persistent neuropathic manifestation the aim of the study is to compare both ultrasound techniques (combined individual nerve block to interscalene nerve block) as regards the postoperative analgesic effect and shoulder range of movement.
Detailed Description
60 patients will be attached to standard monitoring, will have a secured intravenous line Then the skin overlying the procedure area will be sterilized. all patients will be randomly divided into two equal groups; group A will receive ultrasound-guided interscalene block (ISNB), and group B will receive ultrasound-guided selective nerve block (SNB) of the following nerves; suprascapular nerve block (SSNB), axillary nerve block (ANB), lateral pectoral nerve block (LPNB) and musculocutaneous nerve block (MCNB). after delivering the nerve block and confirming sensory blockade by loss of cold sensation, all the patients will receive general anaesthesia with endotracheal intubation using Propofol 200mg, Atracurium 0.5 mg/kg, 100 micrograms fentanyl. After the procedure ends, the patient will be extubated and transferred to the postoperative anaesthesia care unit. All patients will receive patient-controlled analgesia (PCA) in the form ketorolac 30 mg and paracetamol one-gram iv infusion. The following parameter will be assessed and measured; Intra-operative inhalation agent consumption Intraoperative opioid consumption (fentanyl) if required. Duration of postoperative analgesia and time for first rescue analgesia will be recorded. Rescue analgesia in the form of 100mg pethidine IM and 1 gm paracetamol IV will be given on the first call for analgesia and then repeated on demand. The total dose of pethidine and paracetamol are given throughout the first 24 hours will be recorded. The time for asking for rescue analgesia in the first 24 h and the dose of the analgesic used will also be recorded. The degree of postoperative pain assessed by Visual Analogue Scale (VAS) Duration of the block: time from completing LA injection till complete recovery of sensory function, i.e., the patient feels a cold sensation Postoperative range of motion of the operated shoulder Patients" satisfaction (yes or no or somewhat satisfied) Block-related complications will be also recorded e.g. paraesthesia, and postoperative motor weakness 24 hours after the surgery, pneumothorax and vascular puncture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A: receive ultrasound-guided interscalene block
Arm Type
Active Comparator
Arm Description
The patient will be put in the supine position, with the arm adducted a high-frequency linear ultrasound probe is oriented transversely across the lateral neck. When visualizing the ''stoplight sign,''15 to 30 mL of 0.25% bupivacaine consistent with the overall local anaesthetic dosing of less than 2.5 mg/kg. will be injected with low pressures to avoid intraneural injection.
Arm Title
group B: receive ultrasound-guided selective nerve block
Arm Type
Active Comparator
Arm Description
The patient will be put in the sitting position, a linear 38-mm high frequency 10-12 MHz transducer will be placed first on the scapula to obtain a view of the suprascapular nerve a 22 G, 8 cm needle will be advanced in-plane and a total of 5-8 mL of 0.25% bupivacaine is injected then the arm adducted the linear probe will be placed at the junction of the pectoralis major muscle and the biceps muscle such that the axillary artery will be visualized in cross-section The probe will be moved towards the biceps muscle (laterally) until the musculocutaneous nerve is visualized and8 ml of 0.25% bupivacaine will be injected
Intervention Type
Procedure
Intervention Name(s)
interscalene block
Intervention Description
The patient will be put in the supine position, with the arm adducted a high-frequency linear ultrasound probe is oriented transversely across the lateral neck. When visualizing the ''stoplight sign,''15 to 30 mL of 0.25% bupivacaine will be injected
Intervention Type
Procedure
Intervention Name(s)
selective nerve block
Intervention Description
the patient will be put in the sitting position, linear 38-mm high frequency 10-12 MHz transducer will be placed first on the scapula to view of the suprascapular nerve. 5-8 mL of 0.25% bupivacaine is injected to block the SSN. The ultrasound probe put on the posterior aspect of the shoulder to view the circumflex artery, 10 mL of 0.25% bupivacaine this will lead to loss of sensation over the deltoid.lateral pectoral nerve block (LPNB) will be done by injecting a volume of 8 ml of a 0.25% bupivacaine The probe will be moved towards the biceps muscle until the musculocutaneous nerve is seen and 8 ml of 0.25% bupivacaine will be injected.
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Description
bupivacaine
Primary Outcome Measure Information:
Title
the duration of postoperative analgesia
Description
postoperative pain by visual analogue scale (VAS) a 10 point scale where 1 means no pain and 10 means worst pain ever
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
range of motion of the operated shoulder
Description
free or limited
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA I, II scheduled for arthroscopic assisted adhesiolysis Exclusion Criteria: restrictive lung disease, refusal of the procedure, coagulopathy, allergy to any of the used medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fathy M Tash, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
69711
Country
Egypt

12. IPD Sharing Statement

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Evaluating the Analgesic Efficacy of Combined Individual Nerve Block in Comparison to Interscalene Nerve Block

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