Effects of Interpectoral-Pectoserratus Plane Block After Breast Cancer Surgery

NCT05568589 | Unknown

• 1 other identifier: 712
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study: It was aimed to observe the effects of intraoperative and preoperative PECS II block on postoperative pain, amount of analgesic use and shoulder joint range of motion in patients who underwent breast cancer surgery. This research was planned as an observational study. For this purpose, patients who underwent breast cancer surgery in İzmir Bakırçay University Çiğli Training and Research Hospital General Surgery Clinic will be included in the study at the 1st hour after the operation. Patients who underwent preoperative Interpectoral - Pectoserratus Plan Block in the operation will be included in Group 1, patients who have been applied Interpectoral - Pectoserratus Plan Block between the muscle planes by the intraoperative surgeon will be included in Group 2, and patients who have not applied any block will be included in Group 3. Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia, adverse events (pneumothorax, nausea, vomiting, itching, hematoma, allergic reactions) and quality of life, shoulder joint range of motion, hand grip strength (also on day 1) and disability level will be measured on postoperative day 10. H0- Preoperative interpectoral - pectoserratus plane block affects the level of postoperative pain. H1- Preoperativeinterpectoral - pectoserratus plane block does not affect the level of postoperative pain. H2- Intraoperative interpectoral - pectoserratus plane block affects postoperative pain level H3- Intraoperative interpectoral - pectoserratus plane blockk does not affect the level of postoperative pain.

Conditions

Pain, Postoperative; Disability Physical; Quality of Life

Keywords

İnterpectoral plane block; Pectoserratus plane block; Breast Cancer; PECS II Block

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption

  Tramadol consumption in the first 24 hours after surgery

  24 hours

Secondary Outcomes (6)

• NRS scores

  1., 2., 6., 12., 24. hour

• Quality of Recovery

  24th hours

• The disability levels of the patients due to shoulder dysfunction.

  10th day

• Hand grip muscle strength.

  24th hour, 10th day

• Quality of Life (Short Form 36)

  24th hour, 10th day

Study Arms (3)

Preoperative Interpectoral - Pectoserratus Plane Block

The block will be done by the Anesthesiologist.

Other: Preoperative Interpectoral - Pectoserratus Plane Block

Intraoperative Interpectoral - Pectoserratus Plane Block

The block will be made by the surgeon.

Other: Intraoperative Interpectoral - Pectoserratus Plane Block

Non Block

will not be blocked.

Other: Non Block

Interventions

Preoperative Interpectoral - Pectoserratus Plane Block OTHER

Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores at 24th hour (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia , adverse events (pneumothorax, nausea, vomiting, pruritus, hematoma, allergic reactions) and hand grip strength on the postoperative 1st day, quality of life, shoulder joint range of motion, and disability level will be measured on the postoperative 10th day.

Preoperative Interpectoral - Pectoserratus Plane Block

Intraoperative Interpectoral - Pectoserratus Plane Block OTHER

Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores at 24th hour (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia , adverse events (pneumothorax, nausea, vomiting, pruritus, hematoma, allergic reactions) and hand grip strength on the postoperative 1st day, quality of life, shoulder joint range of motion, and disability level will be measured on the postoperative 10th day.

Intraoperative Interpectoral - Pectoserratus Plane Block

Non Block OTHER

Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores at 24th hour (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia , adverse events (pneumothorax, nausea, vomiting, pruritus, hematoma, allergic reactions) and hand grip strength on the postoperative 1st day, quality of life, shoulder joint range of motion, and disability level will be measured on the postoperative 10th day.

Non Block

Eligibility Criteria

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

Study Population

Sixty patients aged \>18 years old who has breast cancer surgery with intraoperative or preoperative interpectoral - pectoserratus plane block o non block will be included in the study. Patients will be randomly divided into three groups including 20 patients each, postoperative 1st hour.

You may qualify if:

• Having had a unilateral breast cancer operation
• Signing the voluntary consent form

You may not qualify if:

• BMI \>35kg/m2 and \<20kg/m2
• Having a rheumatological disease (rheumatoid arthritis, etc.),
• Having neuromuscular disease
• Having a disease that will add shoulder joint movement (arthritis, prosthesis, fracture sequela, etc.)
• Having neuropathy, alcoholism, psychiatric disorder
• Chronic opioid use
• being pregnant
• Patient's refusal to use patient-controlled analgesia
• History of uncontrolled hypertension, diabetes, heart failure, liver failure, kidney failure and/or cerebrovascular disease

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Izmir Bakircay University Cigli Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ömer Faruk Altaş, 1

  İzmir Bakircay University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ömer Faruk Altaş, 1

CONTACT

+905366533992; omerfarukaltas@hotmail.com

Elif Umay Altaş, 2

CONTACT

+905053076622; elifumay.altas@bakircay.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 5, 2022
• Study Start: October 6, 2022
• Primary Completion: January 6, 2023
• Study Completion: April 6, 2023
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)