An interventional study of Radiofrequency stellate ganglion block using ultrasound guidance (SGB) and Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB) in Stellate Ganglion, Radiofrequency Ablation and Complex Regional Pain Syndromes, sponsored by National Cancer Institute, Egypt. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by National Cancer Institute, Egypt · Not applicable, Interventional, and Treatment
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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).
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.
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.
This study's planned enrollment of 150 is above the median of 40 across 152 interventional studies indexed under Complex Regional Pain Syndromes.
Browse Complex Regional Pain Syndromes studies →National Cancer Institute, Egypt is the lead sponsor of 133 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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)
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
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 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.
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.
Time frame: 3 months after intervention
Patient satisfaction
Patient satisfaction by patient satisfaction score (0 very satisfied and 10 dissatisfied)
Time frame: 3 months after intervention
Oxycodone consumption
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
Pregabalin consumption
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
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)
Time frame: 3 months
Patient's Quality of life
Patient's Quality of life according to WHOQOL(who measure quality of life)
Time frame: 3 months
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: 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.
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Mar 2024, 5 months after the start.
Of 64 non-industry interventional studies with no phase under Complex Regional Pain Syndromes, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 5 months is below that.
Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 14 and three quarters within 60.
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