Pectoral Nerves Block vs Wound Infiltration for Partial Mastectomy - a Prospective Randomized Trial.
Study Details
Study Description
Brief Summary
Pectoralis nerves plane block (PECS) first described by Blanco in 2011 has become part of postoperative pain management in breast surgery, thoracic surgery and thoracic trauma. The combination of low complication risk and easiness in mastering of PECS block has made it an interesting alternative to thoracic epidural anesthesia (TEDA) and paravertebral blockade (PVB) for pain treatment after breast surgery. Several studies showed good results when PECS was compared to PVB. PECS blockade however is a procedure requiring some resources in the operating room. An alternative approach is to inject local anesthetics (LA) in the operation field by the surgeon.
The hypothesis' tested in this study is primarily: that PECS blockade is superior to LA being injected by surgeon in the operating field measured by end points such as: post-operative pain, post-operative analgesics use, post-operative nausea or vomiting (PONV) and length of stay in the post anesthesia care unit (PACU).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: PECS+subcutaneus local anesthetic infiltration Preoperative ultrasound-led PECS II blockade with ropivacaine 3,75mg/ml (2mg/kg). After surgery - wound infiltration by the surgeon with ropivacaine 2mg/ml (1mg/kg). |
Procedure: PECS II
Pectoral nerves block (PECS II) is performed with the help of ultrasound. Two injection are performed in two fascial planes. One between pectoralis major muscle and serratus anterior muscle. Second one between pectoralis major and minor muscles.
Other Names:
Procedure: Subcutaneus local anesthetic infiltration
Ropivacaine is administered by the surgeon at the end of surgery
Drug: Ropivacaine
Local anesthetic ropivacaine is administered in both study arms according to the study protocol
Other Names:
Device: bk medical Flex Focus 500 Ultrasound Machine
Ultrasound with linear probe is performed. Using in-plane technique a correct placement of the injection needle is secured.
Other Names:
|
| Active Comparator: Local anesthetic infiltration Prior to scrubbing surgeon infiltrates the thought incision area with ropivacaine 3,75/ml (1mg/kg). Perioperatively after removal of the tumor follows the deep infiltration of the wound with ropivacaine 3,75mg/ml (2mg/kg). |
Procedure: Local anesthetic infiltration
Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor.
Drug: Ropivacaine
Local anesthetic ropivacaine is administered in both study arms according to the study protocol
Other Names:
|
Outcome Measures
Primary Outcome Measures
- maximal pain in PACU measured with 11 point numerical rating scale (NRS) [measured at discharge from PACU (on average 4 hours).]
NRS scale is a validated for assessment of pain.
Secondary Outcome Measures
- Maximal postoperative nausea and vomiting(PONV) in PACU measured with 11 point numerical rating scale (NRS) [measured at discharge from PACU (on average 4 hours).]
PONV NRS similar to pain NRS is an 11 point scale used to estimate severity of postoperative nausea.
- Postoperative analgesic use [measured at 24 hours postoperatively.]
Postoperative analgesic use is related to pain severity and can be a factor leading to increased length of stay in PACU.
- Length of stay in PACU [on average 4 hours.]
Is an dependant of multiple factors and an important measurement that can indicate beneficial therapeutic choice.
- Maximal pain after discharge from PACU measured with 11 point numerical rating scale (NRS) [24 hours]
NRS scale is a validated for assessment of pain.
- Maximal postoperative nausea and vomiting(PONV) after discharge from PACU measured with 11 point numerical rating scale (NRS) [24 hours]
PONV NRS similar to pain NRS is an 11 point scale used to estimate severity of postoperative nausea.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Women scheduled for partial mastectomy (lumpectomy).
Exclusion Criteria:
-
Scheduled cryosection
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Axillary node dissection
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Re-resection
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Age under 18 or unable to give an informed concent
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Chronic pain history
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Allergy to local anesthetics
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History of active drug addiction
-
Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Hospital in Karlstad | Karlstad | Värmland | Sweden | 652 30 |
Sponsors and Collaborators
- Karlstad Central Hospital
Investigators
- Principal Investigator: Ragnar Henningsson, PhD, Örebro University, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
- Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002 Sep;46(8):921-8. Review.
- Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x.
- Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
- Habib AS, Kertai MD, Cooter M, Greenup RA, Hwang S. Risk factors for severe acute pain and persistent pain after surgery for breast cancer: a prospective observational study. Reg Anesth Pain Med. 2019 Feb;44(2):192-199. doi: 10.1136/rapm-2018-000040. Epub 2019 Jan 5.
- Jacobs A, Lemoine A, Joshi GP, Van de Velde M, Bonnet F; PROSPECT Working Group collaborators#. PROSPECT guideline for oncological breast surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2020 May;75(5):664-673. doi: 10.1111/anae.14964. Epub 2020 Jan 26.
- 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.
- LIVFOU-930411