Post Mastectomy Pain Syndrome After Preoperative Stellate Ganglion Block for Breast Cancer Surgeries
- Conditions
- Breast PainBreast Cancer
- Interventions
- Procedure: Stellate Ganglion BlockDrug: Multimodal Analgesia
- Registration Number
- NCT04238377
- Lead Sponsor
- National Cancer Institute, Egypt
- Brief Summary
This study investigate the effect of pre-operative ultrasound guided stellate ganglion block with local anesthetic on the frequency of neuropathic pain syndromes in the first 6-month post cancer breast surgeries with axillary dissection.
- Detailed Description
In this study Eighty Female patients with a diagnosis of breast cancer, underwent breast surgery with axillary dissection at National Cancer Institute, Cairo University were included in this study. Patients will be randomized into two equal comparable groups of patients.
(Group A the study group) was received pre-operative ultrasound guided stellate ganglion block one hour before surgery and multimodal analgesia and (Group B the control group) was received multimodal analgesia only.
The present study showed in regards to the acute pain management of the stellate ganglion block: intraoperative hemodynamics, mean arterial blood pressure and heart rate (MABP, HR) were statistically significant less in group A (Stellate Group) than group B (Control Group) and this leads to significant less opioid consumption in Group A (Stellate Group) than Group B (Control group). In the 1st 24h postoperative opioid consumption measured by number of rescue dose of morphine 5mg IV were administered when visual analogue score was more than 4 and total requirement per 24 hours was recorded. The results show statistically significant less opioid consumption in Group A (Stellate Group) with average visual analogue score 3.5 in 1st 24h than Group B (Control group) with average visual analogue score 5.5 in 1st 24h.
The present study showed in regards to the chronic pain management of the stellate ganglion block that, the 6-month relative frequency of neuropathic pain syndromes, using the grading system for neuropathic pain (GSNP) shows statistically significance lower frequency of neuropathic pain syndromes in Group A (Stellate Group) than Group B (Control group).
Assessment of patient daily activity and functional capacity using Eastern cooperative oncology group (ECOG) scoring showed statistically significance higher performance status (lower numbers in the score) in Group A (Stellate Group) than Group B (Control group).
Number of patients discharged on tramadol \& or Lyrica whom developed Post Mastectomy Pain syndrome (PMPs) is statically significant lower in Group A (Stellate Group) than Group B (Control group).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 80
- Women were eligible if a diagnosis of breast cancer, programmed for breast surgery with axillary dissection, able to understand and willing to follow the study protocol
- Patient refusal - Local infection at the site of injection - Allergy to study medications - Psychosocial disorders - pts on opioid or antianxiety - Sepsis - Anatomic abnormalities - Systemic anticoagulation or coagulopathy - Inability to comprehend or participate in pain scoring system - Recent myocardial infarction - Pathological bradycardia - Glaucoma
- Any contraindication for the multimodal analgesia e.g. (asthmatic patient and use of diclofenac, Diabetic patient and use of steroids)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stellate Group Stellate Ganglion Block will receive pre-operative ultrasound guided stellate ganglion block one hour before surgery and multimodal analgesia and will be followed for 6 months for neuropathic pain as the Stellate Group Stellate Group Multimodal Analgesia will receive pre-operative ultrasound guided stellate ganglion block one hour before surgery and multimodal analgesia and will be followed for 6 months for neuropathic pain as the Stellate Group Control Group Multimodal Analgesia will receive multimodal analgesia only and will be followed for 6 months for neuropathic pain as the control Group
- Primary Outcome Measures
Name Time Method Incidence of Neuropathic pain Syndromes 6 months after surgery relative frequency of neuropathic pain syndromes post breast surgeries with axillary dissection after preoperative ultrasound stellate ganglion block. This is accomplished using the grading system for neuropathic pain (GSNP),0: No Pain,1: Pain, 2: Possible neuropathic: Pain with (A history of relevant neurological lesion or disease AND Pain distribution neuroanatomically plausible, 3: Pain Probable neuropathic: Positive sensory signs (allodynia, hyperalgesia, electric, burning, numbness, itching, maybe motor or autonomic changes) on the distribution of the injured nerves or beyond, 4: Pain Definitive neuropathic: diagnostic test confirms the lesion or disease of the somatosensory nervous system OR a surgeon's clear verification of an intraoperative nerve lesion (intercostobrachial in MRM with Axillary Evacuation in Breast Surgery)
patient daily activity and functional capacity 6 months after surgery Assessment of patient daily activity and functional capacity is evaluated using Eastern cooperative oncology group "ECOG" scoring, (0=fully active, 1= able to perform light effort, 2= in bed \<50% of the day 3=in bed \>50% of the day, 4=bed ridden, 5=died) so the low score the better.
- Secondary Outcome Measures
Name Time Method opioid consumption Post-operative 24 hours opioid consumption using the Visual analogy scale (VAS) score,Post-operative opioid consumption measured by number of rescue dose of morphine 5mg IV administered when VAS was more than 4 and total requirement per 24 hours was recorded.
Trial Locations
- Locations (1)
National Cancer Institute Cairo University
🇪🇬Cairo, Egypt