CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
pregabalin ,tramadol,and tricyclic antidepressants +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03494426
NCT03494426N/ACompleted

Radiofrequency Thoracic Sympathectomy for Chronic Postmastectomy Pain; Randomized Placebo Controlled Study

Assiut University·interventional·Posted Apr 11, 2018·Updated Jan 7, 2020

In Brief

A clinical study evaluating radiofrequency thoracic sympathectomy and pregabalin ,tramadol,and tricyclic antidepressants for Post-Mastectomy Chronic Pain Syndrome. Completed, enrolled 70 participants across 1 site.

Detailed Summary

Postmastectomy pain syndrome (PMPS) is a neuropathic pain that can follow surgical treatment for breast cancer, The antineuropathic medications (antidepressants and anticonvulsants) are disappointing and have low success rate. Continues Radiofrequency lesioning has been reported as treatment for several chronic pain conditions.The concept that the clinical effect of RF was caused by formation of heat had not been challenged. Thermocoagulation of nerve fibers would interfere with the conduction of nociceptive stimuli and pain would be relived. Thoracic sympathectomy has been done for many painful conditions that includes complex regional pain syndrome .It offers the benefit over stellate ganglion block as it blocks the Kuntz fibers that connect to the brachial plexus roots without passing through stellate ganglion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 11, 2018
Enrollment StartApr 1, 2018
Primary CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.2 years ago

Interventions

radiofrequency thoracic sympathectomyprocedure

Under fluoroscopic guidance thoracic sympathectomy will be done as follow 1. antroposterior view of upper thoracic vertebrae ,cephalo-caudal adjustment of C - arm until aliment of endplates of T2 and T3 2. oblique view 20 degree under tunnel view RF 10cm 20G 1mm active tip needle is introduced intimately related to vertebral margin 3. the depth of the needle will be determined under lateral fluoroscopic view the needle is advanced step by step hugging the lateral vertebra l margin until the tip of the needle situated at the middle of the vertebral body . RF lesion 2min 80c will be done and needle is rotated 90 degree on both sides and another two lesions will be done at the end of the procedure 2ml of lidocaine and 20mg of triamcinolone will be injected at each level Post procedure analgesic protocol consisted of either increase or decrease, according to intensity of pain by 50 mg pregabalin and 50 mg tramadole and 25 mg tryptazole, individualized for each patient.

pregabalin ,tramadol,and tricyclic antidepressantsdrug

patient will receive anti neuropathic medications