Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT06033456
Status:
UNKNOWN
Last Update Posted:
2023-10-10
First Post:
2023-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combining Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post-mastectomy Complex Regional Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014284', 'term': 'Triiodothyronine'}], 'ancestors': [{'id': 'D013970', 'term': 'Thyronines'}, {'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D013974', 'term': 'Thyroxine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-07', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-05', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The degree of pain relief', 'timeFrame': '3 months after intervention', 'description': 'Pain relief is assessed by the change in Visual Analogue Scale (VAS) score at 1st day then 1 and 3 months after intervention.\n\nComplete response VAS 0-3. • Partial response VAS 4-6. • No response VAS 7-10.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '3 months after intervention', 'description': 'Patient satisfaction by patient satisfaction score (0 very satisfied and 10 dissatisfied)'}, {'measure': 'Oxycodone consumption', 'timeFrame': '3 months after intervention', 'description': 'The analgesic concomitant medications (oxycodone) consumption will be assessed prior to the block and at 1st day, 1,3 months.'}, {'measure': 'Pregabalin consumption', 'timeFrame': '3 months after intervention', 'description': 'The analgesic concomitant medications (pregabalin) consumption will be assessed prior to the block and at 1st day, 1,3 months.'}, {'measure': 'neuropathic pain', 'timeFrame': '3 months', 'description': 'Neuropathic pain will be evaluated according to the Grading System for Neuropathic Pain (GSNP).\n\nPositive neuropathic cases are those with GSNP 3 (probable) or GSNP 4 (definite) .\n\nThe grading system for neuropathic pain (GSNP) is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite)'}, {'measure': "Patient's Quality of life", 'timeFrame': '3 months', 'description': "Patient's Quality of life according to WHOQOL(who measure quality of life)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stellate Ganglion', 'Radiofrequency Ablation', 'Complex Regional Pain Syndromes', 'Mastectomy']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nComplex 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': '* Female patients.\n* Type of surgery: Modified Radical Mastectomy MRM.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients.\n* Type of surgery: Modified Radical Mastectomy MRM.\n* Physical status ASA II, III.\n* Duration of more than 6 months and less than 2 years.\n* Moderate and severe pain (visual analog scale \\[VAS\\] ≥ 40 mm).\n* Pain described as a refractory to strong opioids (oxycodone) and adjuvant therapy such as(pregabalin) for which more invasive interventions could be tried.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Patient with local and systemic sepsis.\n* Local anatomical distortion.\n* History of contralateral chest disease or pneumonectomy.\n* Known sensitivity or contraindication to the drug used in the study.\n* History of psychological disorders.\n* Contraindication to regional anesthesia, e.g., pre-existing peripheral neuropathies and coagulopathy.\n* Severe respiratory or cardiac disorders. Advanced liver or kidney disease.\n* Pregnancy.\n* Physical status ASA IV and Male patients.'}, 'identificationModule': {'nctId': 'NCT06033456', 'briefTitle': 'Combining Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post-mastectomy Complex Regional Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Efficacy of Combination of Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post Mastectomy Complex Regional Pain Syndrome, Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'AP2302-301-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiofrequency stellate ganglion block using ultrasound guidance (SGB)', '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.\n\nThen, 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 .', 'interventionNames': ['Procedure: Radiofrequency stellate ganglion block using ultrasound guidance (SGB)']}, {'type': 'EXPERIMENTAL', 'label': 'Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance', '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.', 'interventionNames': ['Procedure: Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB)']}, {'type': 'EXPERIMENTAL', 'label': 'Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block', 'description': 'Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block.', 'interventionNames': ['Procedure: Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block']}], 'interventions': [{'name': 'Radiofrequency stellate ganglion block using ultrasound guidance (SGB)', 'type': 'PROCEDURE', '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).\n\nThen, 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', 'armGroupLabels': ['Radiofrequency stellate ganglion block using ultrasound guidance (SGB)']}, {'name': 'Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB)', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance']}, {'name': 'Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block', 'type': 'PROCEDURE', 'description': 'Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block.', 'armGroupLabels': ['Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mary S Gerges, MD', 'role': 'CONTACT', 'email': 'Marysabry136@gmail.com', 'phone': '00201222610774'}, {'name': 'Mahmoud A Kamel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Taher S Thabet, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Suzan A Abdel rahman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hossam Z Ghobrial, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mary S Gerges', 'role': 'CONTACT', 'email': 'Marysabry136@gmail.com', 'phone': '00201222610774'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of Anesthesia, ICU and Pain Management', 'investigatorFullName': 'Mary Sabry', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}