Combining Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post-mastectomy Complex Regional Pain Syndrome

NCT06033456 | Unknown

• 1 other identifier: AP2302-301-0001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of the combination of Ultra Sound (US) guided radiofrequency stellate ganglion block (SGB) and radiofrequency Thoracic Paravertebral block (TPVB) comparing to US-guided SGB or TPVB alone on the post-mastectomy pain syndrome (PMPS).

Conditions

Stellate Ganglion; Radiofrequency Ablation; Complex Regional Pain Syndromes; Mastectomy

Outcome Measures

Primary Outcomes (1)

• The degree of pain relief

  Pain relief is assessed by the change in Visual Analogue Scale (VAS) score at 1st day then 1 and 3 months after intervention. Complete response VAS 0-3. • Partial response VAS 4-6. • No response VAS 7-10.

  3 months after intervention

Secondary Outcomes (5)

• Patient satisfaction

  3 months after intervention

• Oxycodone consumption

  3 months after intervention

• Pregabalin consumption

  3 months after intervention

• neuropathic pain

  3 months

• Patient's Quality of life

  3 months

Study Arms (3)

Radiofrequency stellate ganglion block using ultrasound guidance (SGB)

EXPERIMENTAL

Visualization of the C6-C7 level will be targeted under fluoroscopic posterior-anterior (PA) guidance. Skin will be infiltrated with 1% lidocaine using a 25-gauge needle. Next, the RF needle will be inserted under a trajectory approach toward the target. Then, with ultrasound guidance, using a superficial linear ultrasound probe to guide further needle penetration so that the needle-tip will lie anterior to the longus colli muscle, the exclusion of vascular structures will be confirmed by duplex. Then, 5 to 1 mL of omnipaque dye (iohexol) will be injected. Subsequently, a 100 mm length Baily RF electrode will be inserted and connected to the generator. The RF needle will be positioned alongside the stellate ganglion in the thermal RF technique. With repeated sensory and motor stimulation before RF lesioning .

Procedure: Radiofrequency stellate ganglion block using ultrasound guidance (SGB)

Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance

EXPERIMENTAL

Radiofrequency sympathectomy will be performed with the patient in the prone position. Under fluoroscopic guidance, the T2, T3 vertebral bodies will be identified in an anteroposterior view. For radiofrequency sympathectomy, 10 cm curved, sharp radiofrequency insulated needle with an active tip of 10 mm, needle entry will be performed, and the final placement of the needle tip will be located at the posterior third of the vertebral body in lateral view and just lateral to the body in the anteroposterior view. Once the correct position is confirmed, 0.5 to 1 ml of Omnipaque will be injected, then a 10 cm electrode will be introduced through the RF needle. Before lesioning, a sensory and motor test stimulation is performed to verify the location.

Procedure: Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB)

Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block

EXPERIMENTAL

Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block.

Procedure: Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block

Interventions

Radiofrequency stellate ganglion block using ultrasound guidance (SGB) PROCEDURE

Visualization of C6-C7 level will be targeted under fluoroscopic posterior-anterior (PA) guidance. Skin will be infiltrated with 1% lidocaine using a 25-gauge needle. Next, the RF needle will be inserted under a trajectory approach toward the target. Then, with ultrasound guidance, using a superficial linear ultrasound probe to guide further needle penetration so that the needle-tip will lie anterior to the longus colli muscle, the exclusion of vascular structures will be confirmed by duplex(8). Then, 5 to 1 mL of omnipaque dye (iohexol) will be injected. Subsequently, a 100 mm length Baily RF electrode will be inserted and connected to the generator. The RF needle will be positioned alongside the stellate ganglion in the thermal RF technique. With repeated sensory and motor stimulation before RF lesioning

Radiofrequency stellate ganglion block using ultrasound guidance (SGB)

Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB) PROCEDURE

Radiofrequency sympathectomy will be performed with the patient in the prone position. Under fluoroscopic guidance, the T2, T3 vertebral bodies will be identified in an anteroposterior view. For radiofrequency sympathectomy, 10 cm curved, sharp radiofrequency insulated needle with an active tip of 10 mm, needle entry will be performed, and the final placement of the needle tip will be located at the posterior third of the vertebral body in lateral view and just lateral to the body in the anteroposterior view. Once the correct position is confirmed, 0.5 to 1 ml of Omnipaque will be injected, then a 10 cm electrode will be introduced through the RF needle. Before lesioning, a sensory and motor test stimulation is performed to verify the location.

Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance

Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block PROCEDURE

Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block.

Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: * Female patients. * Type of surgery: Modified Radical Mastectomy MRM.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients.
• Type of surgery: Modified Radical Mastectomy MRM.
• Physical status ASA II, III.
• Duration of more than 6 months and less than 2 years.
• Moderate and severe pain (visual analog scale \[VAS\] ≥ 40 mm).
• Pain described as a refractory to strong opioids (oxycodone) and adjuvant therapy such as(pregabalin) for which more invasive interventions could be tried.

You may not qualify if:

• Patient refusal.
• Patient with local and systemic sepsis.
• Local anatomical distortion.
• History of contralateral chest disease or pneumonectomy.
• Known sensitivity or contraindication to the drug used in the study.
• History of psychological disorders.
• Contraindication to regional anesthesia, e.g., pre-existing peripheral neuropathies and coagulopathy.
• Severe respiratory or cardiac disorders. Advanced liver or kidney disease.
• Pregnancy.
• Physical status ASA IV and Male patients.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Mary S Gerges

CONTACT

00201222610774; Marysabry136@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesia, ICU and Pain Management

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: October 7, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)