Post Mastectomy Pain Syndrome After Preoperative Stellate Ganglion Block for Breast Cancer Surgeries

Evaluation of Post Mastectomy Pain Syndrome After Preoperative Stellate Ganglion Block for Breast Cancer Surgeries, Clinical Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Breast Pain
• Intervention / Treatment: Procedure: Stellate Ganglion Block; Drug: Multimodal Analgesia

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).

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Recruiting
    • National Cancer Institute Cairo University
    • Contact: Ahmed Salman, MSC; Phone Number: +(20)1001728527; Email: ahmed.salman@nci.cu.edu.eg
    • Contact: Ahmed Salah, MD; Phone Number: +(20)1098426689; Email: ahmed.salah@nci.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stellate Group; 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	Procedure: Stellate Ganglion Block; Using US with a linear array transduce, subfascial-C6- Stellate Ganglion Block. Patients will be supine with the neck slightly hyper- extended. After aseptic preparation of the skin, the transducer is placed on the neck to enable cross sectional visualization of anatomical structures at the level of C6. The carotid artery, internal jugular vein, thyroid gland, trachea, longus colli covered with the prevertebral fascia, root of C6, and transverse process of C6 are all visualized. The transducer will then gently be pressed between the carotid artery and trachea to retract the carotid artery laterally and to position the transducer close to the longus colli. A 1.0-inch, 25-gauge long-bevel needle were paratracheal inserted toward the middle of the longus colli. The endpoint for injection were the ultrasound image demonstrating the tip of needle penetrating the prevertebral fascia in the longus colli. After negative aspiration, 5 mL of 0.5% bupivacaine was injected; Other Names: Cervicothoracic Ganglion Block; Drug: Multimodal Analgesia; Multimodal analgesia in the form of administering of IV paracetamol 1000 mg one hour prior to start of surgery in combination 30 mg ketorolac and Single preoperative 0.1 mg/kg dose dexamethasone has a combined action, anti-emetic and provides enhanced analgesia, with intra-operative fast acting opioid analgesics, Fentanyl 2 mic/kg; Other Names: Preventive Analgesia
Placebo Comparator: Control Group; will receive multimodal analgesia only and will be followed for 6 months for neuropathic pain as the control Group	Drug: Multimodal Analgesia; Multimodal analgesia in the form of administering of IV paracetamol 1000 mg one hour prior to start of surgery in combination 30 mg ketorolac and Single preoperative 0.1 mg/kg dose dexamethasone has a combined action, anti-emetic and provides enhanced analgesia, with intra-operative fast acting opioid analgesics, Fentanyl 2 mic/kg; Other Names: Preventive Analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Neuropathic pain Syndromes	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)	6 months after surgery
patient daily activity and functional capacity	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.	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption	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.	Post-operative 24 hours

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Principal Investigator: Ahmed Salman, National Cancer Institute, Cairo Uneversity

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2017
• Primary Completion (Anticipated): March 30, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: January 19, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Stellate Ganglion Block , Neuropathic pain syndromes
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Cysts; Breast Diseases; Connective Tissue Diseases; Mucinoses; Breast Neoplasms; Ganglion Cysts; Mastodynia
• Other Study ID Numbers: 201617048.3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No