Clinical trial NCT04056676: Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery
Official title: Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery, Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Female
Pain, Postoperative
Keywords: Postoperative pain
Thoracic paravertebral block
Modified PEC block
Breast cancer
Total mastectomy with sentinel lymph node clearance
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group A Intraoperative modified PEC block only group B Preoperative thoracic paravertebral block plus intraoperative modified PEC block
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative fentanyl consumption
timeFrame: at postoperative 24 hours
measure: Postoperative fentanyl consumption
timeFrame: at postoperative 48 hours
Secondary outcomes:
measure: Intraoperative fentanyl use
timeFrame: Intraoperation
measure: Postoperative pain score at rest
timeFrame: at postoperative 0 hour (PACU arrival)
measure: Postoperative pain score at rest
timeFrame: at postoperative 30 min (in PACU)
measure: Postoperative pain score at rest
timeFrame: at postoperative 1 hour (in PACU)
measure: Postoperative pain score at rest
timeFrame: Postoperative 6 hour (at ward)
measure: Postoperative pain score at rest
timeFrame: Postoperative 12 hour (at ward)
measure: Postoperative pain score at rest
timeFrame: Postoperative 18 hour (at ward)
measure: Postoperative pain score at rest
timeFrame: Postoperative 24 hour (at ward)
measure: Postoperative pain score on shoulder movement
timeFrame: Postoperative 1 hour (at PACU)
measure: Postoperative pain score on shoulder movement
timeFrame: Postoperative first day (at ward)
measure: Postoperative pain score on shoulder movement
timeFrame: Postoperative second day (at ward)
measure: First time to fentanyl requirement by IV PCA
timeFrame: Within 24 hours
measure: Percentage of patients presenting with opioid-related adverse effects
timeFrame: Within 48 hours
measure: Percentage of patients presenting with nerve block complications
timeFrame: Within 48 hours
measure: Length of hospital stay
timeFrame: From preoperative admission until hospital discharge
measure: Patient's satisfaction scale score
timeFrame: At postoperative 48 hours
measure: Cost effectiveness analysis
timeFrame: Within 48 hours
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Suwimon Tangwiwat, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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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.
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. doi: 10.1097/00000539-200006000-00026.
citation: 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.