Comparison of PECS II Block and Combined Serratus Anterior Plane Block to Reduce Acute Pain After Mastectomy

NCT05961735 | Completed

• 1 other identifier: AnkaraEtlikYusufOzguner004
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, PECS II block or CSAB will be applied to patients who have had a modified radical mastectomy under general anesthesia for postoperative pain relief by using 30 ml of 0.25% bupivacaine .All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period. Pain, nausea-vomiting, additional analgesic and antiemetic drug requirement, within 24 hours postoperatively will be compared between groups. In this study, it was aimed to compare the efficacy of both peripheral nerve block methods in patients after mastectomy.

Conditions

Pain, Postoperative

Keywords

PECS II Block; Combined Serratus Anterior Plane Block; Mastectomy

Outcome Measures

Primary Outcomes (7)

• Pain on the Numeric Rating Scale (NRS)

  Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.

  0 hours postoperatively

• Pain on the Numeric Rating Scale (NRS)

  Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.

  2 hours postoperatively

• Pain on the Numeric Rating Scale (NRS)

  Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.

  4 hours postoperatively

• Pain on the Numeric Rating Scale (NRS)

  Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.

  8 hours postoperatively

• Pain on the Numeric Rating Scale (NRS)

  Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.

  12 hours postoperatively

• Pain on the Numeric Rating Scale (NRS)

  Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.

  24 hours postoperatively

• Total opioid consumption

  All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period.

  24 hours postoperatively

Study Arms (2)

Patients with PECS II Block

PECS 2 block will be applied to patients in this group.

Other: PECS II Block

Patients with Combined Serratus Anterior Plane Block

Combined Serratus Anterior Plane Block will be applied to patients in this group.

Other: Combined Serratus Anterior Plane Block

Interventions

PECS II Block OTHER

The Pecs II block is applied to the patients after induction of anesthesia .

Patients with PECS II Block

Combined Serratus Anterior Plane Block OTHER

Combined Serratus Anterior Plane Block is applied to the patients after induction of anesthesia .

Patients with Combined Serratus Anterior Plane Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who undergone mastectomy surgery

You may qualify if:

• Patients between the ages of 18-80
• Patients with ASA score I-II-III
• Patients with a body mass index (BMI) between 18 and 40
• Patients who underwent PECS-II block or CSAB with mastectomy in the operating room

You may not qualify if:

• Patients under the age of 18 and over the age of 80
• Patients with an ASA score of IV and above
• Patients with advanced co-morbidity
• Patients with a history of bleeding diathesis
• Patients who have infection in the area which is to be blocked
• BMI below 18 and over 40
• Patients undergoing emergency surgery

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (3)

• Maranto CJ, Strickland NR, Goree JH. Combined Superficial and Deep Serratus Plane Block With Bupivacaine, Dexamethasone, and Clonidine in the Treatment of a Patient With Postmastectomy Pain Syndrome: A Case Report. A A Pract. 2018 Nov 1;11(9):236-237. doi: 10.1213/XAA.0000000000000792.

  PMID: 29794801 RESULT

• Zhao J, Han F, Yang Y, Li H, Li Z. Pectoral nerve block in anesthesia for modified radical mastectomy: A meta-analysis based on randomized controlled trials. Medicine (Baltimore). 2019 May;98(18):e15423. doi: 10.1097/MD.0000000000015423.

  PMID: 31045802 RESULT

• Grape S, Jaunin E, El-Boghdadly K, Chan V, Albrecht E. Analgesic efficacy of PECS and serratus plane blocks after breast surgery: A systematic review, meta-analysis and trial sequential analysis. J Clin Anesth. 2020 Aug;63:109744. doi: 10.1016/j.jclinane.2020.109744. Epub 2020 Feb 25.

  PMID: 32109825 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Yusuf Ozguner

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 27, 2023
• Study Start: August 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: June 1, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)