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

NCT04238377 | Unknown

• 1 other identifier: 201617048.3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Pain

Keywords

Stellate Ganglion Block , Neuropathic pain syndromes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• opioid consumption

  Post-operative 24 hours

Study Arms (2)

Stellate Group

ACTIVE COMPARATOR

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; Drug: Multimodal Analgesia

Control Group

PLACEBO COMPARATOR

will receive multimodal analgesia only and will be followed for 6 months for neuropathic pain as the control Group

Drug: Multimodal Analgesia

Interventions

Stellate Ganglion Block PROCEDURE

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

Also known as: Cervicothoracic Ganglion Block

Stellate Group

Multimodal Analgesia DRUG

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

Also known as: Preventive Analgesia

Control Group; Stellate Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute Cairo University

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Mastodynia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Salman

  National Cancer Institute, Cairo Uneversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Salman, MSC

CONTACT

+(20)1001728527; ahmed.salman@nci.cu.edu.eg

Ahmed Abdelgalil, MD

CONTACT

+(20)1098426689; ahmed.salah@nci.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aneasthetist

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 23, 2020
• Study Start: December 26, 2017
• Primary Completion: March 30, 2020
• Study Completion: April 30, 2020
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

EG (1)