Malignant Neoplasm of Breast Clinical Trial
NCT number | NCT02495363 |
Other study ID # | 201-15 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | May 2017 |
Verified date | October 2016 |
Source | Rabin Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Examining the analgesic effect of ultrasound guided Pectoral Blocks on analgesic opioid
consumption after surgical removal of breast tissue.
This study's uniqueness is in the quantification of the analgesic effect of regional
anesthesia on its influence to reduce the use of opioid substances, and the variety of side
effects associated with them, which has yet to been described in literature.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Women over 18 who undergo breast tissue resection under general anesthesia at Beilinson Hospital, and are able to comply with the study's protocol Exclusion Criteria: 1. Lack of patient's consent or lack of patient's ability to provide consent. 2. Known hypersensitivity to local anesthetic or to opioid, which will affect the nature of the pain management therapy in these patients. 3. Existing evidence of infection or gangrene on the thorax which prevents implementation of regional anesthesia - . 4. Known coagulation disorder. |
Country | Name | City | State |
---|---|---|---|
Israel | Rabin Medical Center | Petach Tikvah |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Israel,
Abdallah FW, Morgan PJ, Cil T, McNaught A, Escallon JM, Semple JL, Wu W, Chan VW. Ultrasound-guided multilevel paravertebral blocks and total intravenous anesthesia improve the quality of recovery after ambulatory breast tumor resection. Anesthesiology. 2014 Mar;120(3):703-13. doi: 10.1097/ALN.0000436117.52143.bc. — View 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. — View Citation
Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7. — View Citation
Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137. Review. — View Citation
Fujii Y. Management of postoperative nausea and vomiting in women scheduled for breast cancer surgery. J Anesth. 2011 Dec;25(6):917-22. doi: 10.1007/s00540-011-1241-1. Epub 2011 Oct 1. Review. Retraction in: Hirota K. J Anesth. 2013 Apr;27(2):322. — View Citation
Gärtner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum in: JAMA. 2012 Nov 21;308(19):1973. — View Citation
Macdonald L, Bruce J, Scott NW, Smith WC, Chambers WA. Long-term follow-up of breast cancer survivors with post-mastectomy pain syndrome. Br J Cancer. 2005 Jan 31;92(2):225-30. — View Citation
Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. — View Citation
Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. — View Citation
Poleshuck EL, Katz J, Andrus CH, Hogan LA, Jung BF, Kulick DI, Dworkin RH. Risk factors for chronic pain following breast cancer surgery: a prospective study. J Pain. 2006 Sep;7(9):626-34. — View Citation
Power I. An update on analgesics. Br J Anaesth. 2011 Jul;107(1):19-24. doi: 10.1093/bja/aer126. Epub 2011 May 30. Review. — View Citation
Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14. Review. Erratum in: Br J Anaesth. 2013 Sep;111(3):522. — View Citation
Shin SW, Cho AR, Lee HJ, Kim HJ, Byeon GJ, Yoon JW, Kim KH, Kwon JY. Maintenance anaesthetics during remifentanil-based anaesthesia might affect postoperative pain control after breast cancer surgery. Br J Anaesth. 2010 Nov;105(5):661-7. doi: 10.1093/bja/aeq257. Epub 2010 Sep 28. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scales quantification of the analgesic effect of PECS Block regional anesthesia on its influence to reduce the use of opioid substances, and the variety of side effects associated with them | 24 hours |
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