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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04056676
• Other study ID #: SI 475/2019
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: May 2021
• Source: Mahidol University
• Contact: Suwimon Tangwiwat, MD
• Phone: 66816456167
• Email: stangwiwat[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Pain, Postoperative

Intervention

Procedure:
• Thoracic paravertebral block under ultrasound guidance
Ultrasound-guided thoracic paravertebral blocks in T2, T4 level
• Intraoperative modified PEC block
Pectoral nerve block by surgeon under direct vision after total mastectomy
• GA with ETT
General anesthesia with endotracheal intubation

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

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. — View Citation

Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

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