Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05978427

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Efficacy and safety of superior trunk block versus interscalene block for post-operative analgesia in shoulder surgeries

Condition or Disease	Intervention/Treatment	Phase
Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries	Procedure: interscalene block Procedure: superior trunk block	N/A

Detailed Description

The interscalene brachial plexus block is the gold standard analgesic technique for surgery involving the shoulder and upper arm. However, due to its complications as hemidiaphragmatic paralysis, the superior trunk block was developed in an attempt to reduce major complications.The utility of the superior trunk block has yet to be studied in shoulder surgeries.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: interscalene block group participants undergoing shoulder surgeries will receive ultrasound guided interscalene block	Procedure: interscalene block will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in interscalene block. Procedure: superior trunk block will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in superior trunk block.
Active Comparator: superior trunk block group participants undergoing shoulder surgeries will receive ultrasound guided superior trunk block	Procedure: interscalene block will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in interscalene block. Procedure: superior trunk block will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in superior trunk block.

Arm

Intervention/Treatment

Active Comparator: interscalene block group

participants undergoing shoulder surgeries will receive ultrasound guided interscalene block

Procedure: interscalene block

will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in interscalene block.

Procedure: superior trunk block

will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in superior trunk block.

Active Comparator: superior trunk block group

participants undergoing shoulder surgeries will receive ultrasound guided superior trunk block

Procedure: interscalene block

will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in interscalene block.

Procedure: superior trunk block

will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in superior trunk block.

Outcome Measures

Primary Outcome Measures

diaphragmatic paralysis postoperative [within 24 hours after surgery]
o The incidence of diaphragmatic paralysis postoperative assessed by Diaphragmatic excursion distance by Ultrasound

Secondary Outcome Measures

analgesic efficacy [within 24 hours after surgery]
o Analgesic efficacy of the nerve block in both groups by assessing postoperative pain vas score
rescue analgesia [within 24 hours after surgery]
The total amount of rescue analgesia used
Post operative nausea and vomiting [within 24 hours after surgery]
incidence of post operative complications as nausea an vomiting

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients American Society of Anaesthesiologists physical status (ASA) is I to II.
Both genders.
Aged group from 21 to 50 years old.
Patients electively scheduled for shoulder surgery under general anesthesia with normal coagulation profile.

Exclusion Criteria:

Refusal of the procedure or participation in the study.
Any history or evidence of coagulopathy.
Evidence of infection at injection site.
Allergy to study drugs.
Patients with pulmonary severe respiratory disease.
Herniated cervical disc or cervical myelopathy.
Pre-existing neuropathy of the operative limb

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ainshams University	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ain Shams University

ClinicalTrials.gov Identifier:

NCT05978427

Other Study ID Numbers:

superior trunk vs interscalene

First Posted:

Aug 7, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

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

Keywords provided by Ain Shams University

superior trunk block

interscalene block

Additional relevant MeSH terms:

Agnosia

Study Results

No Results Posted as of Aug 7, 2023