NCT07839611

Brief Summary

the study aims to compare clinical and electrophysiological outcomes of combined stellate ganglion block plus median nerve hydrodissection versus hydrodissection alone in carpal tunnel syndrome, assessing pain, function, autonomic predictors, and safety over time.

Trial Health

65
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Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Sep 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Sep 2026Sep 2027

First Submitted

Initial submission to the registry

August 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 24, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 26, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

stellate ganglion blockmedian nerve hydrodissection

Outcome Measures

Primary Outcomes (1)

  • Change in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score from Baseline to 12 Weeks

    The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) consists of 11 items, each scored from 1 to 5. The overall score is calculated as the mean of the 11 item scores, ranging from 1 to 5. Higher scores indicate greater symptom severity (worse outcome). The outcome is the change from baseline to the specified follow-up time point.

    baseline to 12 weeks

Secondary Outcomes (12)

  • Change in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score from Baseline to 4 Weeks

    from baseline to 4 weeks

  • Change in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score from Baseline to 8 Weeks

    from baseline to 8 weeks

  • Change in Visual Analog Scale for Pain Score from Baseline to 4 Weeks

    from baseline to 4 weeks

  • Change in Visual Analog Scale (VAS) for Pain Score from Baseline to 8weeks

    baseline to 8 weeks

  • Change in Visual Analog Scale (VAS) for Pain Score from Baseline to 12 Weeks

    baseline to 12weeks

  • +7 more secondary outcomes

Study Arms (2)

combined stellate ganglion block with median nerve hydrodissection

EXPERIMENTAL

these patients will recieve combined ultrasound-guided stellate ganglion block (SGB) plus ultrasound-guided median nerve hydrodissection Stellate Ganglion Block Patient supine, neck slightly extended and turned away. Use ultrasound guidance at the C6 level. Identify the carotid artery, thyroid, longus colli muscle, and C6 transverse process. Insert the needle in-plane, avoiding vessels, toward the prevertebral fascia over the longus colli. After aspiration and confirmation of position, inject a small volume of local anesthetic. Observe for successful block, typically ipsilateral Horner syndrome (ptosis, miosis, facial anhidrosis Ultrasound-Guided Median Nerve Hydrodissection Position the patient with the forearm supinated Use a high-frequency linear ultrasound probe to identify the median nerve. Scan the nerve in short axis and identify surrounding vessels Inject a small amount of fluid to open the tissue plane around the nerve, then continue injection to achieve hydrodissection

Procedure: combined stellate ganglion block procedure and median nerve hydrodissection

median nerve hydrodissection only

ACTIVE COMPARATOR

these patients will recieve only ultrasound guided median nerve hydrodissection only as follow Ultrasound-Guided Median Nerve Hydrodissection Position the patient with the forearm supinated. Use a high-frequency linear ultrasound probe to identify the median nerve. Scan the nerve in short axis and identify surrounding vessels and tendons. Insert the needle in-plane, keeping the tip continuously visible. Advance the needle adjacent to the median nerve, without entering the nerve. Inject a small amount of fluid to open the tissue plane around the nerve, then continue injection to achieve circumferential hydrodissection. Confirm separation of the nerve from surrounding structures on ultrasound.

Procedure: Ultrasound-Guided Median Nerve Hydrodissection Procedure only

Interventions

Stellate Ganglion Block - Brief Technique Patient supine, neck slightly extended and turned away. Use ultrasound guidance at the C6 level. Identify the carotid artery, thyroid, longus colli muscle, and C6 transverse process. Insert the needle in-plane, avoiding vessels, toward the prevertebral fascia over the longus colli. After aspiration and confirmation of position, inject a small volume of local anesthetic. Observe for successful block, typically ipsilateral Horner syndrome (ptosis, miosis, facial anhidrosis). Monitor for complications such as vascular injection, hematoma, hoarseness, LAST, and airway compromise.

combined stellate ganglion block with median nerve hydrodissection

Ultrasound-Guided Median Nerve Hydrodissection - Brief Technique Position the patient with the forearm supinated. Use a high-frequency linear ultrasound probe to identify the median nerve. Scan the nerve in short axis and identify surrounding vessels and tendons. Insert the needle in-plane, keeping the tip continuously visible. Advance the needle adjacent to the median nerve, without entering the nerve. Inject a small amount of fluid to open the tissue plane around the nerve, then continue injection to achieve circumferential hydrodissection. Confirm separation of the nerve from surrounding structures on ultrasound. Monitor for pain, paresthesia, vascular puncture, or nerve injury. The total injected volume ranged from 5 to 10 mL for standard hydrodissection without steroid. Either normal saline or 5 percent dextrose in water was used,

median nerve hydrodissection only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or older.
  • Patients diagnosed with carpal tunnel syndrome based on compatible clinical symptoms and signs.
  • Diagnosis confirmed by nerve conduction studies/electrodiagnostic testing.
  • Patients with mild to moderate carpal tunnel syndrome.
  • Patients with persistent symptoms despite conservative treatment.
  • Patients eligible for ultrasound-guided median nerve hydrodissection.
  • Patients willing to participate in the study and provide written informed consent.

You may not qualify if:

  • Previous surgical treatment for carpal tunnel syndrome in the affected hand.
  • Severe carpal tunnel syndrome with marked thenar muscle wasting or severe axonal loss.
  • Coexisting cervical radiculopathy or peripheral polyneuropathy.
  • Previous fracture, major trauma, or surgery involving the affected wrist or hand.
  • Other neurological or musculoskeletal conditions affecting the symptoms or functional assessment of the affected upper limb.
  • Local infection, inflammation, or skin lesion at the injection site.
  • Known bleeding disorder or contraindication to the injection procedure.
  • Current anticoagulant therapy that contraindicates the procedure.
  • Known allergy or contraindication to any medication used during the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • A Sousa LH, Costa CO, Novak EM, Giostri GS. Complex Regional Pain Syndrome after Carpal Tunnel Syndrome Surgery: A Systematic Review. Neurol India. 2022 Mar-Apr;70(2):491-503. doi: 10.4103/0028-3886.344616.

    PMID: 35532609BACKGROUND
  • Bland JDP. Hydrodissection for treatment of carpal tunnel syndrome. Muscle Nerve. 2018 Jan;57(1):4-5. doi: 10.1002/mus.25759. Epub 2017 Aug 21. No abstract available.

    PMID: 28786115BACKGROUND
  • Huang CY, Lai CY, Reeves KD, Lam KHS, Li TY, Cheng CI, Wu YT. Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome: A Prospective, Randomized, and Single-Blind Study. J Ultrasound Med. 2024 Jan;43(1):161-169. doi: 10.1002/jum.16349. Epub 2023 Oct 24.

    PMID: 37873682BACKGROUND
  • Lee K, Park JM, Yoon SY, Kim MS, Kim YW, Shin JI, Lee SC. Ultrasound-Guided Nerve Hydrodissection for the Management of Carpal Tunnel Syndrome: A Systematic Review and Network Meta-Analysis. Yonsei Med J. 2025 Feb;66(2):111-120. doi: 10.3349/ymj.2024.0089.

    PMID: 39894044BACKGROUND
  • Pokharel S, Silwal S, Shrestha P, Neupane K. Ultrasound Guided Hydrodissection of Median Nerve with the Use of 5% Dextrose in Carpal Tunnel Syndrome: A Case Report. JNMA J Nepal Med Assoc. 2024 Sep;62(277):611-613. doi: 10.31729/jnma.8751. Epub 2024 Sep 30.

    PMID: 40655054BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Central Study Contacts

zeyad nabil researcher, master's reseacher

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the study will be assessor-blinded: The proceduralist cannot be blinded. Participants will be informed they will receive one of two active interventions; however, full participant blinding is not feasible without sham SGB. Outcome assessors (BCTQ, VAS, clinical tests), electrophysiology personnel (ENMG/NCS), and the statistician will be blinded to allocation. Group labels will be coded (Group 1/Group 2) until analysis is completed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a prospective, randomized, two-arm interventional clinical trial comparing combined ultrasound-guided stellate ganglion block (SGB) plus ultrasound-guided median nerve hydrodissection (Group A) versus ultrasound guided median nerve hydrodissection alone (Group B) in adults with mild-moderate carpal tunnel syndrome (CTS). The trial will be conducted at Fayoum University Hospital, Department of Pain Medicine and Anesthesia, after Institutional Review Board (IRB) approval. Written informed consent will be obtained from all participants prior to enrollment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident,Department of anesthesia and surgical intensive care

Study Record Dates

First Submitted

August 26, 2026

First Posted

September 24, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

September 24, 2026

Record last verified: 2026-08