Pain Control After Arthroscopic Shoulder Surgeries

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05686395

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will be conducted to compare the perioperative analgesic efficacy of ultrasound - guided interscalene brachial plexus block versus combined shoulder anterior capsular block and anterior suprascapular nerve block for arthroscopic shoulder surgeries.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Procedure: Ultrasound-guided Interscalene Block group Procedure: Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block Drug: Bupivacaine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparative Study of Analgesic Efficacy of Ultrasound Guided Interscalene Block Versus Combined Shoulder Anterior Capsular Block and Suprascapular Nerve Block for Arthroscopic Shoulder Surgeries.

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group 1 Ultrasound-guided Interscalene Block group In this group, ultrasound-guided ISB will be done using 10 ml of bupivacaine 0.25%.	Procedure: Ultrasound-guided Interscalene Block group ultrasound guided interscalene block versus combined ultrasound guided shoulder anterior capsular block and suprascapular nerve block for arthroscopic shoulder surgery Drug: Bupivacaine bupivacaine 0.25%.
Active Comparator: group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block , ultrasound-guided SHAC block will be done using 10 ml of bupivacaine 0.25% injected in the interfacial plane between deltoid and subscapular muscle and 10 ml of bupivacaine 0.25% injected in the pericapsular space. Ultrasound-guided SSN block will be done using 10 ml of bupivacaine 0.25% injected at sub omohyoid space.	Procedure: Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block Drug: Bupivacaine bupivacaine 0.25%.

Arm

Intervention/Treatment

Active Comparator: group 1 Ultrasound-guided Interscalene Block group

In this group, ultrasound-guided ISB will be done using 10 ml of bupivacaine 0.25%.

Procedure: Ultrasound-guided Interscalene Block group

ultrasound guided interscalene block versus combined ultrasound guided shoulder anterior capsular block and suprascapular nerve block for arthroscopic shoulder surgery

Drug: Bupivacaine

bupivacaine 0.25%.

Active Comparator: group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block

, ultrasound-guided SHAC block will be done using 10 ml of bupivacaine 0.25% injected in the interfacial plane between deltoid and subscapular muscle and 10 ml of bupivacaine 0.25% injected in the pericapsular space. Ultrasound-guided SSN block will be done using 10 ml of bupivacaine 0.25% injected at sub omohyoid space.

Procedure: Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block

Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block

Drug: Bupivacaine

bupivacaine 0.25%.

Outcome Measures

Primary Outcome Measures

post operative analgesic consumption [24 hours after surgery]
The first 24 hours post operative analgesic consumption

Secondary Outcome Measures

Visual Analogue score (VAS) in the first 24 hours after surgery [first 24 hours after surgery]
- Postoperative pain intensity will be assessed in the first 24 hour using VAS score where (0 = no pain and 100 = the worst imaginable pain)
Patient satisfaction score [first 24 hours after surgery]
Patient satisfaction score will be assessed on the basis of a questionnaire and graded on a 4-point scale (excellent/good/fair/poor).
The incidence of hemi diaphragmatic paralysis [immediately before block and immediately after procedure]
hemidiaphragmatic paralysis after block

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged 20-65 years of both sexes, with American Society of Anesthesiologists (ASA) physical status I or II admitted for arthroscopic shoulder surgery.

Exclusion Criteria:

Patient refusal.
Uncooperative patient.
Patient with neurological deficit.
Patients with respiratory disorders.
Patient with bleeding disorders.
Infection at the block injection site.
Patients with history of allergy to local anesthetics.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Tanta University	Tanta		Egypt

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hosameldin Ibrahim Ibrahim Elsayed Eldib, ASSISTANT LECTURER OF ANESTHESIA AND INTENSIVE CARE AND PAIN MEDICINE, Tanta University

ClinicalTrials.gov Identifier:

NCT05686395

Other Study ID Numbers:

IRB0010038

First Posted:

Jan 17, 2023

Last Update Posted:

Jan 17, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Bupivacaine

Study Results

No Results Posted as of Jan 17, 2023