Effect of Anesthesia on Expression of Programmed Death-1 and Programmed Death-1 Ligand in Breast Cancer

NCT04657237 | Unknown

• 1 other identifier: 359
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Surgery is first-line treatment for solid tumors. However, surgical trauma-induced physiologic stress has been demonstrated to facilitate metastasis and recurrence in different types of cancer. It has been reported that the PD-1/PD-L1 pathway could be activated by surgical stress. Hence, we instigate the effect of anesthetic technique on expression of PD1 and PD1 ligand.

Conditions

Programmed Cell Death 1

Keywords

brest cancer; programmed cell death1; programmed cell death ligand 1

Outcome Measures

Primary Outcomes (1)

• change in level of PD1 and PD1 ligand postoperatively

  blood sample will be withdrawn and human peripheral blood monocyte cells (PBMCs) will be separated with a Ficoll-Isopaque density gradient. Flow cytometric analyses will be carried out immediately. For ex vivo experiments, PBMCs will be cultured with Iscove's modified Dulbecco's medium (IMDM) containing 10 % human serum albumin.

  preoerative (day-0),1st day, and 3 rd day after surgery

Secondary Outcomes (1)

• total request of analgesia

  24 hours postoperative

Study Arms (2)

control group

NO INTERVENTION

all patients will receive general anesthesia and will receive intravenous paracetamol (1 g) before skin closure and then given every 6 hrs in the 1st postoperative day

TPVB group

ACTIVE COMPARATOR

Patients will receive total volume (20 ml) 0.25% bubivicaine divided equally at each level of T4 and T6 at thoracic paravertebral space then they will recive general anesthesia.

Procedure: Thoracic Paravertebral block

Interventions

Thoracic Paravertebral block PROCEDURE

TPVB will be given using high frequency linear U/S transducer, place the U/S ultrasound probe was placed parallel to the vertebral spine at T4, and, T6 level and shifted 2-3 cm laterally to obtain the appropriate visualization. Following the identification of pleura, transverse process and paravertebral space, the needle was inserted in caudocranial direction using in-plane approach. Confirm negative vessel or pleural breach via aspiration then proceed with local anaesthetic 0.25% bupivacaine (20 ml) delivery slowly divided equally at T4and T6; the pleura will be seen to be pushed downward

TPVB group

Eligibility Criteria

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

You may qualify if:

• patients scheduled for breast cancer surgery

You may not qualify if:

• compromised immune function (such as infection with the human immunodeficiency virus, immunodeficiency, or treatment with corticosteroids, immunosuppressive drugs, or chemotherapy)
• ASA \> III
• age\> 70 years old.
• patients refusal to the procedure.
• Infection of the skin at or near site of needle puncture.
• Coagulopathy .
• Drug hypersensitivity or allergy to the studied drugs.
• Central or peripheral neuropthy .
• Pre-operative opoid consumption ( within 24 hours preoperative )
• Anomalies of the vertebral column .

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

South Egypt Cancer Institute

Asyut, 11715, Egypt

RECRUITING

Central Study Contacts

shereen M kamal, assocate professor

CONTACT

01006279209; sheridouh79@yahoo.com

Hassan I Kotb, professor

CONTACT

01287332042; kotbhi@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU and pain managment

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 8, 2020
• Study Start: January 1, 2017
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)