NCT04238377

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Cancer
• Breast Pain

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2017-12-26
• Primary completion: 2020-03-30
• Completion: 2020-04-30
• First posted: 2020-01-23
• Last updated: 2020-01-23

Locations

1 site across 1 country: Egypt