Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PECS+subcutaneus local anesthetic infiltration | Active Comparator | 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). |
|
| Local anesthetic infiltration | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PECS II | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| maximal pain in PACU measured with 11 point numerical rating scale (NRS) | NRS scale is a validated for assessment of pain. It is a 11 point scale (0-10) used to estimate severity of postoperative pain. On NRS scale the higher value indicates more severe symptoms. | measured at discharge from PACU (on average 4 hours). |
| Intraoperative fentanyl use | dose of fentanyl used during surgery in milligrams [mg]. | Time is measured from start of the anesthesia until discharge to PACU (on average 3 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative analgesic use | Postoperative analgesic use is related to pain severity and can be a factor leading to increased length of stay in PACU. | measured at 24 hours postoperatively. |
| Maximal postoperative nausea and vomiting(PONV) in PACU measured with 11 point numerical rating scale (NRS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ragnar Henningsson, PhD | Örebro University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital in Karlstad | Karlstad | Värmland County | 652 30 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31984479 | Background | 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. | |
| 21831090 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Local anesthetic infiltration | Procedure | Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor. |
|
| Subcutaneus local anesthetic infiltration | Procedure | Ropivacaine is administered by the surgeon at the end of surgery |
|
| Ropivacaine | Drug | Local anesthetic ropivacaine is administered in both study arms according to the study protocol |
|
|
| bk medical Flex Focus 500 Ultrasound Machine | Device | Ultrasound with linear probe is performed. Using in-plane technique a correct placement of the injection needle is secured. |
|
|
PONV NRS similar to pain NRS is an 11 point scale (0-10) used to estimate severity of postoperative nausea. On NRS scale the higher value indicates more severe symptoms. |
| measured at discharge from PACU (on average 4 hours). |
| Length of stay in PACU | Is an dependant of multiple factors and an important measurement that can indicate beneficial therapeutic choice. | on average 4 hours. |
| Maximal postoperative nausea and vomiting(PONV) after discharge from PACU measured with 11 point numerical rating scale (NRS) | PONV NRS similar to pain NRS is an 11 point scale used to estimate severity of postoperative nausea. | 24 hours |
| Maximal pain after discharge from PACU measured with 11 point numerical rating scale (NRS) | NRS scale is a validated for assessment of pain. | 24 hours |
| 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. No abstract available. |
| 12190791 | Background | Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002 Sep;46(8):921-8. doi: 10.1034/j.1399-6576.2002.460801.x. |
| 28820803 | 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. |
| 30700614 | Background | 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. |
| 21856077 | Background | 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. |
| 38550709 | Derived | Eisler P, Zimmermann S, Henningsson R. Interpectoral and Pectoserratus Plane Block vs. Local Anesthetic Infiltration for Partial Mastectomy: A Prospective Randomized Trial. Pain Res Manag. 2024 Mar 20;2024:9989997. doi: 10.1155/2024/9989997. eCollection 2024. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |