US Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation

Not Applicable

Completed

• Conditions: Analgesia; Breast Cancer
• Interventions: Procedure: Erector Spinae Plane Block with Bubivacaine; Procedure: Standard General Anaesthesia

• Registration Number: NCT04796363
• Lead Sponsor: Alexandria University

Brief Summary

Prospective interventional study

Detailed Description

The aim of the present study is to evaluate the effect of US guided unilateral ESPB using different volumes of local anaesthetics on analgesic efficacy, dermatomal spread and immunomodulation in breast cancer surgery.

The primary outcome is the analgesic efficacy of the different local anaesthetic volumes of ESPB.

The secondary outcomes are the dermatomal dye spread and sensory coverage, immunomodulation and complications in breast cancer surgery.

Immunomodulation will be assessed by measuring Natural killer cells cytotoxicity.

Study Timeline

• Study First Submitted: 2020-11-24
• Study Start: 2020-11-25
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-12
• Primary Completion: 2022-01-11
• Study Completion: 2022-01-21
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-03
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

ASA physical status 1 or 2 scheduled for mastectomy under the effect of General Anaesthesia

Exclusion Criteria

1. Patient refusal.
2. Allergy or contraindication to any of the studied medications or anaesthetic agents.
3. Chronic opioid analgesic use.
4. Pregnancy.
5. Morbid obesity (BMI ≥ 40 kg/m2).
6. Scoliosis or any vertebral anomalies or previous spinal surgeries.
7. Infection at the site of injection or any other contraindication for regional anaesthesia.
8. Duration of surgery more than 90 minutes.
9. Renal impairment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESPB Bubivacaine 0.25%	Erector Spinae Plane Block with Bubivacaine	20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 20 ml bupivacaine 0.25 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4.
ESPB Bubivacaine 0.125%	Erector Spinae Plane Block with Bubivacaine	20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 40 ml bupivacaine 0.125 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4.
No ESPB	Standard General Anaesthesia	20 patients will undergo standard general anaesthesia as a control group and postoperative analgesia with intravenous morphine patient controlled analgesia (PCA) and rescue analgesia if required.

Primary Outcome Measures

Name	Time	Method
Analgesic efficacy of ESPB	Up to 24 postoperative hours	Analgesic efficacy of Erector Spinae plabe block by measuring visual analogue scale which ranges from 0 to 10. 0 indicates no pain and 10 indicates maximum imaginable pain

Secondary Outcome Measures

Name	Time	Method
Spread of the injected dye in Erector Spinae plane	Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery.	5 ml of radio-contrast dye will be injected in Erector Spinae plane with different dose of Bupivacaine at the level of 4th thoracic vertebra then spread of the dye will be assessed by CT scan (for example dye spread to first thoracic vertebra level cranially and 9th thoracic vertebra caudally).; 3 D reconstruction of the image will be done then Craniocaudal spread of the contrast and spread to Paravertebral space, epidural space or rami of the spinal nerves will be assessed and recorded.
Dermatomal sensory coverage of ESPB	Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB.	will be assessed by hyposthesia to cold sensation. Field of sensory block from T1 to T6 will be assessed bilaterally every 3 minutes for 15 minutes after deep ESPB using a piece of cotton soaked in iced water. The adequacy of sensory block T1-T6 will be determined before induction of general anaesthesia.

Trial Locations

Locations (1)

Medical Research Institute, Alexandria University; 🇪🇬 Alexandria, Egypt