Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery

NCT04056676 | Unknown

• 1 other identifier: SI 475/2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To compare efficacy and safety of adding thoracic paravertebral nerve blocks to modified PEC block versus modified PEC block only in breast cancer surgery. This study evaluate systemic opioid requirement in 48 hours in primary outcome and the analgesic profile ( pain score at rest and on shoulder movement), opioid-related side effects and nerve blocks complications.

Conditions

Breast Cancer Female; Pain, Postoperative

Keywords

Postoperative pain; Thoracic paravertebral block; Modified PEC block; Breast cancer; Total mastectomy with sentinel lymph node clearance

Outcome Measures

Primary Outcomes (2)

• Postoperative fentanyl consumption

  Cumulative fentanyl consumption within postoperative 24 hours

  at postoperative 24 hours

• Postoperative fentanyl consumption

  Cumulative fentanyl consumption within postoperative 24-48 hours

  at postoperative 48 hours

Secondary Outcomes (17)

• Intraoperative fentanyl use

  Intraoperation

• Postoperative pain score at rest

  at postoperative 0 hour (PACU arrival)

• Postoperative pain score at rest

  at postoperative 30 min (in PACU)

• Postoperative pain score at rest

  at postoperative 1 hour (in PACU)

• Postoperative pain score at rest

  Postoperative 6 hour (at ward)

Study Arms (2)

Intraoperative modified PEC block only

ACTIVE COMPARATOR

Intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon

Procedure: Intraoperative modified PEC block; Procedure: GA with ETT

Adding preoperative thoracic paravertebral nerve block

EXPERIMENTAL

Preoperative thoracic paravertebral nerve block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug and intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon

Procedure: Thoracic paravertebral block under ultrasound guidance; Procedure: Intraoperative modified PEC block; Procedure: GA with ETT

Interventions

Thoracic paravertebral block under ultrasound guidance PROCEDURE

Ultrasound-guided thoracic paravertebral blocks in T2, T4 level

Also known as: USG-TPVB

Adding preoperative thoracic paravertebral nerve block

Intraoperative modified PEC block PROCEDURE

Pectoral nerve block by surgeon under direct vision after total mastectomy

Also known as: Modified PEC block

Adding preoperative thoracic paravertebral nerve block; Intraoperative modified PEC block only

GA with ETT PROCEDURE

General anesthesia with endotracheal intubation

Adding preoperative thoracic paravertebral nerve block; Intraoperative modified PEC block only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) grade I-III
• Aged ≥ 18-80 years old
• Elective unilateral total mastectomy with sentinel lymph node biopsy or lymph node dissection

You may not qualify if:

• Patient refusal
• Language barrier or inability to communicate with the operating team
• Allergy to local anesthetic
• Bleeding disorder
• Previous breast surgery or thoracic radiation therapy
• BMI ≥ 30
• Patient who can not understand the proper use of intravenous patient-controlled analgesia machine or who has the problem with communication
• Chronic pain patient

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (7)

• Missair A, Cata JP, Votta-Velis G, Johnson M, Borgeat A, Tiouririne M, Gottumukkala V, Buggy D, Vallejo R, Marrero EB, Sessler D, Huntoon MA, Andres J, Casasola OL. Impact of perioperative pain management on cancer recurrence: an ASRA/ESRA special article. Reg Anesth Pain Med. 2019 Jan;44(1):13-28. doi: 10.1136/rapm-2018-000001.

  PMID: 30640648 BACKGROUND

• Woodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641.

  PMID: 28820803 BACKGROUND

• Wynne R, Lui N, Tytler K, Koffsovitz C, Kirwa V, Riedel B, Ryan S. The Trajectory of Postoperative Pain Following Mastectomy with and without Paravertebral Block. Pain Manag Nurs. 2017 Aug;18(4):234-242. doi: 10.1016/j.pmn.2017.03.003. Epub 2017 Jun 7.

  PMID: 28601480 BACKGROUND

• Syal K, Chandel A. Comparison of the post-operative analgesic effect of paravertebral block, pectoral nerve block and local infiltration in patients undergoing modified radical mastectomy: A randomised double-blind trial. Indian J Anaesth. 2017 Aug;61(8):643-648. doi: 10.4103/ija.IJA_81_17.

  PMID: 28890559 BACKGROUND

• Terkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80.

  PMID: 26431130 BACKGROUND

• Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.

  PMID: 10825328 BACKGROUND

• Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

  PMID: 25376971 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Suwimon Tangwiwat, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suwimon Tangwiwat, MD

CONTACT

66816456167; stangwiwat@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomized group of patient is identified and sealed in envelope. There is not written group in anesthetic record. Postoperative outcomes are assessed by Acute Pain Service nurse or a resident (co-investigator who blinds to the technique).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Department of Anesthesiology

Model Details: group A Intraoperative modified PEC block only group B Preoperative thoracic paravertebral block plus intraoperative modified PEC block

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 14, 2019
• Study Start: August 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

TH (1)