Effectiveness of Ultrasound Guided PECS Block on Opioid Consumption and Patient Satisfaction Through Adequate Pain Control Following Breast Cancer Surgery.

• Sponsor: Aga Khan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04343807
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.9
• Patients Per Site Per Month: 8.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Female; Pain, Postoperative; Pain; Analgesia; Anaesthesia; Breast Cancer	Procedure: PECS Block; Other: Control Group	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jul 30, 2022
• Anticipated Study Completion Date: Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PECS block For patients in PECS group (PG), after induction of general anesthesia, the nerve block will be performed using the ultrasound-guided technique described by Blanco and colleagues. Block will be performed with a 22-gauge 100 mm needle (Stimuplex, B. Braun Medical Inc., Pennsylvania, USA) using Mindray M7 imaging system (Diagnostic Instruments Inc., China) with a high-frequency (6-13 MHz) linear array transducer.20 mL of ropivacaine 0.25% in 5-mL increments will be injected, aspirating gently between injections. The needle will be withdrawn to place the tip in the fascial plane between the pectoralis major and pectoralis minor muscles and ropivacaine 0.25%, 10 ml in 5 ml increments will be injected. Injectate spread between the muscles will be visualized. For patients in control group, no nerve block will be performed and only intravenous nalbuphine will be given.	Procedure: PECS Block; PECS nerve block will be performed using the ultrasound-guided technique described by Blanco and colleagues. Block will be performed with a 22-gauge 100 mm needle (Stimuplex, B. Braun Medical Inc., Pennsylvania, USA) using Mindray M7 imaging system (Diagnostic Instruments Inc., China) with a high-frequency (6-13 MHz) linear array transducer.20 mL of ropivacaine 0.25% in 5-mL increments will be injected, aspirating gently between injections. The needle will be withdrawn to place the tip in the fascial plane between the pectoralis major and pectoralis minor muscles and ropivacaine 0.25%, 10 ml in 5 ml increments will be injected. Injectate spread between the muscles will be visualized. For patients in control group, no nerve block will be performed and only intravenous nalbuphine will be given.
Active Comparator: Control Group For patients in control group, after induction of general anesthesia, no nerve block will be performed and only intravenous nalbuphine will be given.	Other: Control Group; No nerve block will be performed and only intravenous nalbuphine will be given.

Outcome Measures

Primary Outcome Measures

1. Total intraoperative opioid consumption [During surgical procedure]

   Total intraoperative nalbuphine

2. Total postoperative opioid consumption [First 24 hours after surgery]

   Total Rescue Tramadol Consumption

Secondary Outcome Measures

1. Patient Satisfaction [First 24 hours after surgery]

   Patient satisfaction with post-operative analgesia will be noted via satisfaction scoring i.e.: = Not Satisfied = Good or satisfied = Excellent or very satisfied

2. Postoperative pain score [1, 6,12 and 24 hours after surgery]

   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).

3. Postoperative nausea and vomiting [First 24 hours after surgery]

   Yes or No

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aga Khan University Hospital	Karachi	Sindh	Pakistan

Sponsors and Collaborators

• Aga Khan University

Investigators

• Principal Investigator: Faisal Shamim, FCPS, Aga Khan University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Faisal Shamim, Associate Professor Anaesthesiology, Aga Khan University
• ClinicalTrials.gov Identifier: NCT04343807
• Other Study ID Numbers: 3543
• First Posted: Apr 13, 2020
• Last Update Posted: Jan 31, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Pain, Postoperative

Study Results

No Results Posted as of Jan 31, 2022