Clinical trial NCT04343807: Effectiveness of Ultrasound Guided PECS Block on Opioid Consumption and Patient Satisfaction Through Adequate Pain Control Following Breast Cancer Surgery.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasm Female
Pain, Postoperative
Pain
Analgesia
Anaesthesia
Breast Cancer
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The traditional pain management for patients undergoing MRM has relied heavily on opioids but a number of multimodal pain control strategies also exist including combining opioids with NSAIDs, cyclooxygenase-2 inhibitors, acetaminophen and regional blocks. Recently, literature underlines the importance of performing regional anaesthetic and analgesic techniques for postoperative analgesia following breast surgery. PECS (Pectoral nerve block) block provides analgesia for breast surgeries with few adverse effects.

OBJECTIVES To evaluate the effect of ultrasound guided pectoral block in reducing intraoperative and postoperative opioid consumption following modified radical mastectomy.

The secondary objective is to determine patient satisfaction levels associated with adequate pain control.

HYPOTHESIS Pectoral nerve blocks provides superior analgesia with less opioid consumption and improves patient satisfaction in postoperative period compared to conventional pain management for modified radical mastectomy patients

Eligibility criteria: 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

Primary outcomes:
measure: Total intraoperative opioid consumption
timeFrame: During surgical procedure
measure: Total postoperative opioid consumption
timeFrame: First 24 hours after surgery
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: First 24 hours after surgery
measure: Postoperative pain score
timeFrame: 1, 6,12 and 24 hours after surgery
measure: Postoperative nausea and vomiting
timeFrame: First 24 hours after surgery
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Faisal Shamim, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.