Study Results
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Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2017-05-23
2020-10-22
Brief Summary
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The current study aims to determine which of the two strategies that is best in relation to postoperative pain, nausea and risk of recurrence of the disease.
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Detailed Description
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Surgery always comes at the cost of a painful stimuli. It is of great importance that the anesthetist has anticipated this pain and has a plan to handle it.
The most common way to do this is to anesthetise the patient (put him or her to sleep, also called a General Anesthesia (GA)) for the surgical procedure and administer a strong analgesic (usually morphine) before the patient is awaken. Morphine has side-effects.
Another possible plan is to rely on a Regional Anesthesia (RA) (block pain from a certain part of the body) to take care of the pain, both during and after the surgery. Thereby this patient may be awake during the surgery. The two strategies may also be combined. That is, a regional anesthesia is applied before surgery but the patient is also put to sleep. The regional anesthesia is then fully effective when the patient is awaken and no strong analgesics are administered. The approach with a regional anesthesia is common in orthopedic surgery, either in combination with or without a general anesthesia.
For surgery on the breast, there has been few alternatives available for regional anesthesia. They have been considered to invasive for regular use and not been incorporated in clinical praxis as a routine.
The praxis of regional anesthesia has expanded tremendously in recent years. This is attributed to the increased use of ultrasound as a guide for the injection of anesthetic compounds in proximity to the nerves. The pectoral nerve block (PECS) was first described in 2011. It has since then been developed further and is much more feasible than the older alternatives for regional anesthesia covering the breast.
Therefore it has gained some popularity and a few studies on its performance have been published in recent years. It is still not clear though, if it really confers the patient a better postoperative situation regarding pain and nausea.
Further, observational studies have suggested that malignant disease is spread and hence recurs less often if the surgery is performed in conjunction with a regional anesthesia. These results have not yet been confirmed in randomized trials. Therefore, the investigators will use the data from the current study and also look if there is a difference between the study groups regarding recurrence of the disease and mortality three and five years after inclusion in the study.
A subgroup analysis will be made on the patients that has a mastectomy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GA with RA
Regional Anesthesia and General Anesthesia.
Ropivacaine 5 mg/ml, 35 ml
Regional Anesthesia. The deposition of local anesthetics in proximity of nerves with the aim of blocking nerve transmission. This is used to block pain as an alternative to systemic treatment of pain.
Remifentanil 50 microg/ml
The intravenous administration of anesthetics aiming to induce analgesia (part of the general anesthesia). No fixed dose, administered in relation to the study participants need at the moment.
Betamethason 4 mg
Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered preoperatively.
Paracetamol 1,5 g
Administered preoperatively to prevent pain postoperatively.
Propofol
The intravenous administration of anesthetics aiming to induce sleep (part of the general anesthesia). No fixed dose, administered in relation to the study participants need at the moment.
Arcoxia, 120 mg
Administered preoperatively to prevent pain postoperatively.
Ondansetron 4 mg
Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered peroperative.
GA without RA
Only General Anesthesia (without a supplemental Regional Anesthesia).
Remifentanil 50 microg/ml
The intravenous administration of anesthetics aiming to induce analgesia (part of the general anesthesia). No fixed dose, administered in relation to the study participants need at the moment.
Betamethason 4 mg
Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered preoperatively.
Paracetamol 1,5 g
Administered preoperatively to prevent pain postoperatively.
Propofol
The intravenous administration of anesthetics aiming to induce sleep (part of the general anesthesia). No fixed dose, administered in relation to the study participants need at the moment.
Arcoxia, 120 mg
Administered preoperatively to prevent pain postoperatively.
Ondansetron 4 mg
Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered peroperative.
Morphine
Administered peroperative, at the end of the surgery, before awakening the study participant. The aim is to prevent pain.
Interventions
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Ropivacaine 5 mg/ml, 35 ml
Regional Anesthesia. The deposition of local anesthetics in proximity of nerves with the aim of blocking nerve transmission. This is used to block pain as an alternative to systemic treatment of pain.
Remifentanil 50 microg/ml
The intravenous administration of anesthetics aiming to induce analgesia (part of the general anesthesia). No fixed dose, administered in relation to the study participants need at the moment.
Betamethason 4 mg
Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered preoperatively.
Paracetamol 1,5 g
Administered preoperatively to prevent pain postoperatively.
Propofol
The intravenous administration of anesthetics aiming to induce sleep (part of the general anesthesia). No fixed dose, administered in relation to the study participants need at the moment.
Arcoxia, 120 mg
Administered preoperatively to prevent pain postoperatively.
Ondansetron 4 mg
Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered peroperative.
Morphine
Administered peroperative, at the end of the surgery, before awakening the study participant. The aim is to prevent pain.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
Metastases other than in the axilla
Body Mass Index (BMI) \> 35
Not able to communicate in Swedish
Dementia
American Society of Anesthesiology (ASA) 4 or 5
Chronic pain treatment (use of opiates or medicine for neuropathic pain \> 7 days the last month)
Known allergy to Morphine or Ropivacaine
Congestive Heart Failure, New York Heart Association (NYHA) IIIB or worse
Chronic renal failure (S-creatinine increased)
Immunosuppression (more than 10 mg daily of Prednisolone or stronger medication)
No axillary exploration planned
18 Years
FEMALE
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Principal Investigators
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Joakim Johansson, PhD
Role: PRINCIPAL_INVESTIGATOR
Umea University
Locations
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Östersund Hospital
Östersund, Jämtland County, Sweden
Countries
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References
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Ahlberg H, Wallgren D, Hultin M, Myrberg T, Johansson J. Less use of rescue morphine when a combined PSP/IPP-block is used for postoperative analgesia in breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2023 Sep 1;40(9):636-642. doi: 10.1097/EJA.0000000000001795. Epub 2023 Jan 12.
Other Identifiers
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UmeaU-PECS
Identifier Type: -
Identifier Source: org_study_id
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