Breast Cancer Clinical Trial
Official title:
Effectiveness of Ultrasound Guided PECS Block on Opioid Consumption and Patient Satisfaction Through Adequate Pain Control Following Breast Cancer Surgery. A Prospective Randomized Controlled Trial
NCT number | NCT04343807 |
Other study ID # | 3543 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | August 30, 2024 |
Breast cancer is the most common and leading cause of cancer deaths among females worldwide. Patients undergoing modified radical mastectomy (MRM) are associated with moderate to severe acute postoperative pain and shoulder mobility restriction. This study aims to determine the effectiveness of ultrasound-guided PECS block for reducing opioid consumption, providing adequate postoperative pain management and improving patient satisfaction following breast cancer surgery.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | August 30, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients undergoing elective modified radical mastectomy (MRM) - All adults aged between 18 and 65 years - ASA (American Society of Anesthesiologists ) I & II Exclusion Criteria: - Patient refusal - Hypersensitivity to local anaesthetics - Coagulopathy or bleeding diathesis - Local infection at the site of block - BMI more than 35 kg/m2 - Chest wall deformity or previous breast surgery - MRM with latissimus dorsi or deep inferior epigastric perforator flap reconstruction |
Country | Name | City | State |
---|---|---|---|
Pakistan | Aga Khan University Hospital | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University |
Pakistan,
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, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29. — View Citation
M N, Pandey RK, Sharma A, Darlong V, Punj J, Sinha R, Singh PM, Hamshi N, Garg R, Chandralekha C, Srivastava A. Pectoral nerve blocks to improve analgesia after breast cancer surgery: A prospective, randomized and controlled trial. J Clin Anesth. 2018 Mar;45:12-17. doi: 10.1016/j.jclinane.2017.11.027. Epub 2017 Dec 11. — View Citation
Morioka H, Kamiya Y, Yoshida T, Baba H. Pectoral nerve block combined with general anesthesia for breast cancer surgery: a retrospective comparison. JA Clin Rep. 2015;1(1):15. doi: 10.1186/s40981-015-0018-1. Epub 2015 Sep 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total intraoperative opioid consumption | Total intraoperative nalbuphine | During surgical procedure | |
Primary | Total postoperative opioid consumption | Total Rescue Tramadol Consumption | First 24 hours after surgery | |
Secondary | Patient Satisfaction | Patient satisfaction with post-operative analgesia will be noted via satisfaction scoring i.e.:
= Not Satisfied = Good or satisfied = Excellent or very satisfied |
First 24 hours after surgery | |
Secondary | Postoperative pain score | Numeric rating scale for pain assessment: Patient will be asked to rate their intensity of pain on numeric scale from 0 (no pain) to 10 (worst possible pain). | 1, 6,12 and 24 hours after surgery | |
Secondary | Postoperative nausea and vomiting | Yes or No | First 24 hours after surgery |
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