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The analgesic efficacy of erector spinae plane block, a novel locoregional anesthesia technique in breast cancer surgery


- candidate number26900
- NTR NumberNTR6662
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mrt-2017
- Secondary IDsT2017-07 / NL61106.091.17 Bernhoven / CMO
- Public TitleThe analgesic efficacy of erector spinae plane block, a novel locoregional anesthesia technique in breast cancer surgery
- Scientific TitleThe effect of erector spinae plane block on postoperatiev pain and opioid use in patients undergoing breast cancer surgery with sentinal node dissection
- ACRONYMESPB-pilot
- hypothesisESPB gives effective analgesia when compared with paravertebral block in a more safe manner
- Healt Condition(s) or Problem(s) studiedMastectomy, Breast cancer, Locoregional anesthesia
- Inclusion criteria- > 18 years old
- ASA I - III
- written informed consent
- Exclusion criteria- Allergy or contra-indication for paracetamol, etoricoxib or oxycodone
- Chronic opioid use
- Known hypersensitivity or contraindication for local anesthetics
- Bleeding or infection at the puncture site
- Contraindications for regional anesthesia
- Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2017
- planned closingdate1-apr-2018
- Target number of participants10
- Interventionserector spinae plane block
- Primary outcome- postoperative NRS pain scores
- postoperative opioid use
- Secondary outcome- Time to perform procedure in minutes by the anaesthesiologist placing the ESPB.
- Patient satisfaction with post-operative analgesia (NRS score asked 24 hours after surgery, 0 = very dissatisfied, 10 = very satisfied)
- Patient discomfort during placement of the ESPB (NRS score, 0 = very uncomfortable, 10 = absolutely comfortable)
- Incidence of side-effects and complications
- Timepoints- during placement of the block
- 24 hours postoperative
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Gertie Filippini
- CONTACT for SCIENTIFIC QUERIESMD. M.G.E. Fenten
- Sponsor/Initiator Bernhoven Hospital, Department of Anaesthesiology and Surgery
- Funding
(Source(s) of Monetary or Material Support)
Bernhoven Hospital, Department of Anaesthesiology and Surgery
- Publications
- Brief summaryThe incidence of breast cancer in women is high and still increasing. Surgically treated breast cnacer patients have one of the highest incidences of chronic pain when compared to other cancer related surgery. Chronification of postoperative pain isamongst other factors influenced by severe postoperative pain. Locoregional techniques have gained popularity as an adjunct to general anesthesia for breast cancer surgery, for their ability to reduce postoperative pain with minimal side effects.
The objective of this study is to compare analgesic efficacy of paravertebral block with erector spinae plane block in patienst undergoing breast cancer surgery. This pilot study will comparing prospectively collected data from 10 patients receiving erector spinae plane block with retrospective data from 10 patients who received standard care, i.e. paravertebral block.
- Main changes (audit trail)
- RECORD14-mrt-2017 - 8-sep-2017


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