NCT07798115

Brief Summary

This study aims to evaluate whether adding magnesium sulfate to a combined costoclavicular and suprascapular nerve block improves postoperative pain control in patients undergoing shoulder arthroscopy. The study will compare pain management outcomes between patients receiving the nerve block with magnesium sulfate and those receiving the nerve block without magnesium sulfate. The main outcome will be the time to first rescue analgesia after surgery.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Sep 2026Mar 2028

First Submitted

Initial submission to the registry

August 21, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

August 21, 2026

Last Update Submit

August 27, 2026

Conditions

Keywords

Costoclavicular BlockSuprascapular BlockMagnesium SulfatePostoperative PainShoulder ArthroscopyRescue Analgesia

Outcome Measures

Primary Outcomes (1)

  • Time to first rescue analgesia after discharge from PACU.

    Time to first rescue analgesia will be measured from the time of discharge from the Post-Anesthesia Care Unit (PACU) until the first administration of rescue analgesic medication for 24 hour due to postoperative pain. Numeric Rating Scale (NRS): Pain intensity was assessed using the 11-point Numeric Rating Scale (NRS), in which 0 = no pain and 10 = the worst pain imaginable.

    From discharge from PACU until 24 hours postoperatively.

Secondary Outcomes (8)

  • Postoperative Pain Score Using the Numeric Rating Scale

    At predetermined time points after surgery at ( 2h,6h,12h,18h,24h) during the first 24 hours postoperatively.

  • Total Postoperative analgesic Consumption

    First 24 hours postoperatively (one day).

  • Duration of sensory block

    From completion of the nerve block until the first administration of rescue analgesia24 hours postoperatively.

  • Heart rate

    From baseline before the nerve block until the end of surgery.

  • Systolic blood pressure (SBP)

    From baseline before anesthesia induction until 24 hours postoperatively.

  • +3 more secondary outcomes

Study Arms (3)

Costoclavicular-Suprascapular Block with Normal Saline

EXPERIMENTAL

Participants will receive a single-shot ultrasound-guided costoclavicular brachial plexus block with 5 mL of 0.5% bupivacaine (25 mg) combined with 1.5 mL of 0.9% normal saline, followed by an ultrasound-guided suprascapular nerve block with 10 mL of 0.5% bupivacaine (50 mg) combined with 1.5 mL of 0.9% normal saline.

Drug: BupivacaineDrug: Normal Saline (NS)Procedure: Costoclavicular Nerve BlockProcedure: suprascapular nerve block

Costoclavicular-Suprascapular Block with regional Magnesium Sulfate

EXPERIMENTAL

Participants will receive a single-shot ultrasound-guided costoclavicular brachial plexus block with 5 mL of 0.5% bupivacaine (25 mg) combined with 1.5 mL of magnesium sulfate (150 mg), followed by an ultrasound-guided suprascapular nerve block with 10 mL of 0.5% bupivacaine (50 mg) combined with 1.5 mL of magnesium sulfate (150 mg).

Drug: BupivacaineDrug: Magnesium sulfate (MgSO4)Procedure: Costoclavicular Nerve BlockProcedure: suprascapular nerve block

Costoclavicular-Suprascapular Block with Intravenous Magnesium Sulfate

EXPERIMENTAL

Participants will receive a single-shot ultrasound-guided costoclavicular brachial plexus block with 5 mL of 0.5% bupivacaine (25 mg) combined with 1.5 mL of 0.9% normal saline, followed by an ultrasound-guided suprascapular nerve block with 10 mL of 0.5% bupivacaine (50 mg) combined with 1.5 mL of 0.9% normal saline. Following the nerve blocks, participants will receive 150 mg of magnesium sulfate diluted in 100 mL of 0.9% normal saline administered intravenously.

Drug: BupivacaineDrug: Magnesium sulfate (MgSO4)Drug: Normal Saline (NS)Procedure: Costoclavicular Nerve BlockProcedure: suprascapular nerve block

Interventions

"A single-shot ultrasound-guided costoclavicular nerve block will be performed using 5 mL of 0.5% bupivacaine (25 mg), with either 1.5 mL of magnesium sulfate (150 mg) or 1.5 mL of 0.9% normal saline, according to the assigned study group."

Costoclavicular-Suprascapular Block with Intravenous Magnesium SulfateCostoclavicular-Suprascapular Block with Normal SalineCostoclavicular-Suprascapular Block with regional Magnesium Sulfate

"A single-shot ultrasound-guided suprascapular nerve block will be performed using 10 mL of 0.5% bupivacaine (50 mg), with either 1.5 mL of magnesium sulfate (150 mg) or 1.5 mL of 0.9% normal saline, according to the assigned study group."

Costoclavicular-Suprascapular Block with Intravenous Magnesium SulfateCostoclavicular-Suprascapular Block with Normal SalineCostoclavicular-Suprascapular Block with regional Magnesium Sulfate

"Bupivacaine 0.5% will be used as the local anesthetic for ultrasound-guided costoclavicular and suprascapular nerve blocks. A total of 25 mg (5 mL) will be administered for the costoclavicular nerve block and 50 mg (10 mL) for the suprascapular nerve block, for a total dose of 75 mg per participant."

Costoclavicular-Suprascapular Block with Intravenous Magnesium SulfateCostoclavicular-Suprascapular Block with Normal SalineCostoclavicular-Suprascapular Block with regional Magnesium Sulfate

"Magnesium sulfate 150 mg (1.5 mL) will be used as an adjuvant to bupivacaine in each ultrasound-guided nerve block. A total of 300 mg (3 mL) of magnesium sulfate will be administered per participant, with 150 mg added to the costoclavicular nerve block and 150 mg added to the suprascapular nerve block."

Costoclavicular-Suprascapular Block with Intravenous Magnesium SulfateCostoclavicular-Suprascapular Block with regional Magnesium Sulfate

"Normal saline (0.9% sodium chloride) will be used as the control adjuvant, with 1.5 mL added to the local anesthetic solution for the costoclavicular nerve block and 1.5 mL added to the local anesthetic solution for the suprascapular nerve block, for a total volume of 3 mL per participant."

Costoclavicular-Suprascapular Block with Intravenous Magnesium SulfateCostoclavicular-Suprascapular Block with Normal Saline

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-50 years
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Scheduled for elective outpatient shoulder arthroscopy.
  • Ability to understand the study protocol and use the NRS scale.

You may not qualify if:

  • Refusal to participate.
  • Known allergy or hypersensitivity to local anesthetics or magnesium sulphate.
  • Coagulopathy or anticoagulant therapy contraindicating regional anesthesia.
  • Local infection at the block site.
  • Pre-existing peripheral neuropathy or neurologic deficit involving the operative limb.
  • Body mass index (BMI) \> 40 kg/m² (if desired for technical standardization).
  • Chronic opioid use or chronic pain syndrome affecting pain assessment.
  • Pregnancy or lactation.
  • Inability to communicate or complete postoperative assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (6)

  • Pirotesak S, Fallah N, Alruqaie R, Rodelo K, Asenjo JF, Aliste J. Costoclavicular brachial plexus block for shoulder surgery: a narrative review. Korean J Anesthesiol. 2025 Dec;78(6):513-523. doi: 10.4097/kja.25422. Epub 2025 Aug 4.

    PMID: 40755089BACKGROUND
  • Soleimanpour H, Imani F, Dolati S, Soleimanpour M, Shahsavarinia K. Management of pain using magnesium sulphate: a narrative review. Postgrad Med. 2022 Apr;134(3):260-266. doi: 10.1080/00325481.2022.2035092. Epub 2022 Feb 7.

    PMID: 35086408BACKGROUND
  • Jo Y, Oh C, Lee WY, Chung HJ, Park J, Kim YH, Ko Y, Chung W, Hong B. Randomised comparison between superior trunk and costoclavicular blocks for arthroscopic shoulder surgery: A noninferiority study. Eur J Anaesthesiol. 2022 Oct 1;39(10):810-817. doi: 10.1097/EJA.0000000000001735. Epub 2022 Aug 17.

    PMID: 35975762BACKGROUND
  • Nam YS, Jeong JJ, Han SH, Park SE, Lee SM, Kwon MJ, Ji JH, Kim KS. An anatomic and clinical study of the suprascapular and axillary nerve blocks for shoulder arthroscopy. J Shoulder Elbow Surg. 2011 Oct;20(7):1061-8. doi: 10.1016/j.jse.2011.04.022. Epub 2011 Aug 11.

    PMID: 21839653BACKGROUND
  • Galluccio F, Fajardo Perez M, Yamak Altinpulluk E, Hou JD, Lin JA. Evaluation of Interfascial Plane and Pericapsular Nerve Blocks to the Shoulder Joint: A Preliminary Analysis of Shoulder Anterior Capsular Block. Pain Ther. 2021 Dec;10(2):1741-1754. doi: 10.1007/s40122-021-00326-0. Epub 2021 Oct 20.

    PMID: 34669181BACKGROUND
  • Kay J, Memon M, Hu T, Simunovic N, Duong A, Paul J, Athwal G, Ayeni OR. Suprascapular Nerve Blockade for Postoperative Pain Control After Arthroscopic Shoulder Surgery: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2018 Dec 28;6(12):2325967118815859. doi: 10.1177/2325967118815859. eCollection 2018 Dec.

    PMID: 30627589BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineMagnesium SulfateSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Mohamed Mohamed Abdel Latif, professor

    Assiut University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Eman Ahmed Ismail, professor

    Assiut University, Faculty of Medicine

    STUDY DIRECTOR
  • Mohamed Talaat Mohamed, Lecturer

    Assiut University, Faculty of Medicine

    STUDY DIRECTOR
  • Ahmed Shaban Abd Elbadea Khalifa, Assistant lecturer

    Assiut University, Faculty of Medicine

    STUDY CHAIR

Central Study Contacts

Ahmed Shaban Abd elbadea Khalifa, Assistant lecturer

CONTACT

Mohamed Talaat Mohamed, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors will be blinded to group allocation. The anesthesiologist performing the nerve blocks will be aware of the treatment assignment. The study medications and solutions will be prepared to maintain blinding of participants and outcome assessors.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three parallel groups. Group A (control) will receive ultrasound-guided single-shot costoclavicular and suprascapular nerve blocks using bupivacaine with normal saline. Group B will receive the same nerve blocks with magnesium sulfate added to the local anesthetic solution. Group C will receive the same nerve blocks with normal saline, followed by intravenous administration of 150 mg magnesium sulfate diluted in 100 mL normal saline after completion of the nerve blocks. Participants will be followed postoperatively to assess analgesic outcomes, with time to first rescue analgesia as the primary outcome.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesiology

Study Record Dates

First Submitted

August 21, 2026

First Posted

September 1, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

March 30, 2028

Last Updated

September 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers because no plan for IPD sharing has been established. Study data will be used for the purposes of the current research and will be handled in accordance with institutional policies and applicable ethical and privacy requirements.

Locations