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

NCT ID: NCT06033456

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-07
• Study Completion Date: 2024-03-15

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).

Detailed Description

Breast cancer is the most common malignancy among females, with an incidence of about 2.1 million women each year. It is the most common cause of cancer-related deaths among women. Modified Radical Mastectomy (MRM) is one of the main surgical treatments for breast cancer. It accounts for 31% of all breast surgery cases. Nearly 40-60% of breast surgery patients experience severe acute postoperative pain, with severe pain persisting for 6-12 months in almost 20-50% of patients (post-mastectomy pain syndrome.

Complex regional pain syndrome (CRPS) is a clinical diagnosis with a highly variable presentation and prognosis. CRPS type I, previously known as reflex sympathetic dystrophy (RSD), is not associated with direct nerve injury. CRPS type II, or causalgia, is associated with direct injury of a specific nerve, often from surgical intervention or trauma. Symptoms include severe pain, sensitivity to light touch, burning, sweating, skin discoloration, edema, temperature changes, loss of motor function, and decreased range of motion of the affected limb. The mechanism of CRPS is not fully understood with central and peripheral sensitization involved.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiofrequency stellate ganglion block using ultrasound guidance (SGB)

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 .

Group Type: EXPERIMENTAL

Radiofrequency stellate ganglion block using ultrasound guidance (SGB)

Intervention Type: 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 thoracic (T2, T3) paravertebral block under fluoroscopic guidance

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

Interventions

Radiofrequency stellate ganglion block using ultrasound guidance (SGB)

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

Intervention Type: PROCEDURE

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

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.

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Mary Sabry

Assistant lecturer of Anesthesia, ICU and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cancer Institute

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mary S Gerges

Role: CONTACT

Marysabry136@gmail.com

00201222610774

Facility Contacts

Mary S Gerges, MD

Role: primary

Marysabry136@gmail.com

00201222610774

Other Identifiers

AP2302-301-0001

Identifier Type: -

Identifier Source: org_study_id