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

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT04796363

Collaborator

(none)

Enrollment

Location

Arms

13.9

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective interventional study

Condition or Disease	Intervention/Treatment	Phase
Analgesia Breast Cancer	Procedure: Erector Spinae Plane Block with Bubivacaine Procedure: Standard General Anaesthesia	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 25, 2020

Actual Primary Completion Date :

Jan 11, 2022

Actual Study Completion Date :

Jan 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ESPB Bubivacaine 0.25% 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.	Procedure: Erector Spinae Plane Block with Bubivacaine Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery
Active Comparator: ESPB Bubivacaine 0.125% 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.	Procedure: Erector Spinae Plane Block with Bubivacaine Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery
Placebo Comparator: No ESPB 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.	Procedure: Standard General Anaesthesia Standard General Anaesthesia without ESPB

Arm

Intervention/Treatment

Experimental: ESPB Bubivacaine 0.25%

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.

Procedure: Erector Spinae Plane Block with Bubivacaine

Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery

Active Comparator: ESPB Bubivacaine 0.125%

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.

Procedure: Erector Spinae Plane Block with Bubivacaine

Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery

Placebo Comparator: No ESPB

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.

Procedure: Standard General Anaesthesia

Standard General Anaesthesia without ESPB

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Immunomodulation of ESPB [Before ESPB and 24 hours after the block.]
Immunomodulation of ESPB by measuring Natural Killer cells cytotoxicity. Samples of 1 ml of patients' peripheral blood will be collected on EDTA for flow cytometry to enumerate for both cytotoxic lymphocyte populations (NK cells and cytotoxic t lymphocytes (Ctls)). CD 56 will be used as a marker for NK cells, while CD 8 will be used as a marker for Ctls. Cytotoxicity assay will be done by measuring the release of lactate dehydrogenase (LDH) from cells. Then ratio of LDH released specifically from NK cells will be correlated according to the results of flow cytometry.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Exclusion Criteria:

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