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

Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery, Prospective Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Breast Cancer Female
• Intervention / Treatment: Procedure: Intraoperative modified PEC block; Procedure: GA with ETT; Procedure: Thoracic paravertebral block under ultrasound guidance

Detailed Description

Regional anesthesia has been used and studied extensively in breast surgery as an opioid-sparing strategy, with block of the intercostal supply by thoracic paravertebral block (TPVB) becoming a popular technique.

This prospective randomized controlled trial is aimed to study the proper regional nerve block technique to reach the postoperative opioid-free requirement modality for breast cancer surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suwimon Tangwiwat, MD; Phone Number: 66816456167; Email: stangwiwat@yahoo.com

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Recruiting
      • Faculty of Medicine Siriraj Hospital, Mahidol University
      • Contact: Suwimon Tangwiwat, M.D; Phone Number: (66)81-645-6167; Email: stangwiwat@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intraoperative modified PEC block only; Intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon	Procedure: Intraoperative modified PEC block; Pectoral nerve block by surgeon under direct vision after total mastectomy; Other Names: Modified PEC block; Procedure: GA with ETT; General anesthesia with endotracheal intubation
Experimental: Adding preoperative thoracic paravertebral nerve block; 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: Intraoperative modified PEC block; Pectoral nerve block by surgeon under direct vision after total mastectomy; Other Names: Modified PEC block; Procedure: GA with ETT; General anesthesia with endotracheal intubation; Procedure: Thoracic paravertebral block under ultrasound guidance; Ultrasound-guided thoracic paravertebral blocks in T2, T4 level; Other Names: USG-TPVB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl use	Dosage of intraoperative fentanyl usage in micrograms	Intraoperation
Postoperative pain score at rest	Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)	at postoperative 0 hour (PACU arrival)
Postoperative pain score at rest	Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)	at postoperative 30 min (in PACU)
Postoperative pain score at rest	Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)	at postoperative 1 hour (in PACU)
Postoperative pain score at rest	Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)	Postoperative 6 hour (at ward)
Postoperative pain score at rest	Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)	Postoperative 12 hour (at ward)
Postoperative pain score at rest	Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)	Postoperative 18 hour (at ward)
Postoperative pain score at rest	Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)	Postoperative 24 hour (at ward)
Postoperative pain score on shoulder movement	Numeric rating score ((0= no pain, 10= worst pain imaginable)	Postoperative 1 hour (at PACU)
Postoperative pain score on shoulder movement	Numeric rating score ((0= no pain, 10= worst pain imaginable)	Postoperative first day (at ward)
Postoperative pain score on shoulder movement	Numeric rating score ((0= no pain, 10= worst pain imaginable)	Postoperative second day (at ward)
First time to fentanyl requirement by IV PCA	time to require fentanyl patient-controlled intravenous analgesia	Within 24 hours
Percentage of patients presenting with opioid-related adverse effects	adverse effects include postoperative nausea, vomiting, dizziness, pruritus	Within 48 hours
Percentage of patients presenting with nerve block complications	nerve block complications include pneumothorax, hypotension, local anesthetic systemic toxicity, Horner syndrome	Within 48 hours
Length of hospital stay	Number of hospital admission days	From preoperative admission until hospital discharge
Patient's satisfaction scale score	Satisfaction scale score 0-10 (0= highly unsatisfied, 10= highly satisfied)	At postoperative 48 hours
Cost effectiveness analysis	Cost of adding nerve block and postoperative pain score	Within 48 hours

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Suwimon Tangwiwat, MD, Mahidol University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Breast cancer; Thoracic paravertebral block; Postoperative pain; Modified PEC block; Total mastectomy with sentinel lymph node clearance
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Breast Diseases; Pain, Postoperative; Breast Neoplasms
• Other Study ID Numbers: SI 475/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No