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

Primary Purpose

Stellate Ganglion, Radiofrequency Ablation, Complex Regional Pain Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Radiofrequency stellate ganglion block using ultrasound guidance (SGB)
Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB)
Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stellate Ganglion

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Radiofrequency stellate ganglion block using ultrasound guidance (SGB)

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

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

Arm Description

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 .

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient satisfaction
Patient satisfaction by patient satisfaction score (0 very satisfied and 10 dissatisfied)
Oxycodone consumption
The analgesic concomitant medications (oxycodone) consumption will be assessed prior to the block and at 1st day, 1,3 months.
Pregabalin consumption
The analgesic concomitant medications (pregabalin) consumption will be assessed prior to the block and at 1st day, 1,3 months.
neuropathic pain
Neuropathic pain will be evaluated according to the Grading System for Neuropathic Pain (GSNP). Positive neuropathic cases are those with GSNP 3 (probable) or GSNP 4 (definite) . The grading system for neuropathic pain (GSNP) is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite)
Patient's Quality of life
Patient's Quality of life according to WHOQOL(who measure quality of life)

Full Information

First Posted
September 5, 2023
Last Updated
October 7, 2023
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT06033456
Brief Title
Combining Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post-mastectomy Complex Regional Pain Syndrome
Official Title
Efficacy of Combination of Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post Mastectomy Complex Regional Pain Syndrome, Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2023 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stellate Ganglion, Radiofrequency Ablation, Complex Regional Pain Syndromes, Mastectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency stellate ganglion block using ultrasound guidance (SGB)
Arm Type
Experimental
Arm Description
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 .
Arm Title
Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance
Arm Type
Experimental
Arm Description
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.
Arm Title
Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block
Arm Type
Experimental
Arm Description
Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency stellate ganglion block using ultrasound guidance (SGB)
Intervention Description
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
Intervention Name(s)
Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB)
Intervention Description
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
Intervention Name(s)
Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block
Intervention Description
Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block.
Primary Outcome Measure Information:
Title
The degree of pain relief
Description
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.
Time Frame
3 months after intervention
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Patient satisfaction by patient satisfaction score (0 very satisfied and 10 dissatisfied)
Time Frame
3 months after intervention
Title
Oxycodone consumption
Description
The analgesic concomitant medications (oxycodone) consumption will be assessed prior to the block and at 1st day, 1,3 months.
Time Frame
3 months after intervention
Title
Pregabalin consumption
Description
The analgesic concomitant medications (pregabalin) consumption will be assessed prior to the block and at 1st day, 1,3 months.
Time Frame
3 months after intervention
Title
neuropathic pain
Description
Neuropathic pain will be evaluated according to the Grading System for Neuropathic Pain (GSNP). Positive neuropathic cases are those with GSNP 3 (probable) or GSNP 4 (definite) . The grading system for neuropathic pain (GSNP) is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite)
Time Frame
3 months
Title
Patient's Quality of life
Description
Patient's Quality of life according to WHOQOL(who measure quality of life)
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients. Type of surgery: Modified Radical Mastectomy MRM.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary S Gerges
Phone
00201222610774
Email
Marysabry136@gmail.com
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary S Gerges, MD
Phone
00201222610774
Email
Marysabry136@gmail.com
First Name & Middle Initial & Last Name & Degree
Mahmoud A Kamel, MD
First Name & Middle Initial & Last Name & Degree
Taher S Thabet, MD
First Name & Middle Initial & Last Name & Degree
Suzan A Abdel rahman, MD
First Name & Middle Initial & Last Name & Degree
Hossam Z Ghobrial, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
after the end of study for one year.
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Learn more about this trial

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

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