We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Interpectoral-Pectoserratus Plane Block After Breast Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05568589
Recruitment Status : Not yet recruiting
First Posted : October 5, 2022
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
Omer Faruk Altas, Izmir Bakircay University

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.


Condition or disease Intervention/treatment
Pain, Postoperative Disability Physical Quality of Life Other: Preoperative Interpectoral - Pectoserratus Plane Block Other: Intraoperative Interpectoral - Pectoserratus Plane Block Other: Non Block

Detailed Description:

Breast cancer is the most common type of cancer among women and the most common cause of death worldwide. While there has been a serious decrease in the mortality rate due to developments in diagnosis and treatment, there have been serious increases in functional disability and disability due to the disease. Breast cancer can lead to various functional losses due to the nature of the disease itself, radical surgical interventions and radiotherapy applications. These include shoulder dysfunction (pain and limitation of joint movement), locomotor system disorders such as upper extremity muscle strength loss and lymphedema, as well as psychological and cosmetic problems, and as a result, these problems affect the quality of life (QOL) of individuals (1).

Firstly, Blanco et al. Ultrasound-guided pectoralis nerve II block (Interpectoral and pectoserratus plan block - PECS II block), described by MD, is increasingly used for analgesia in breast surgery (2). It has been reported that PECS II block is effective in reducing postoperative pain intensity and opioid consumption (3). It is safe and relatively simple to apply as an interfascial plane block, and there is no sympathetic blockade (4). The PECS II block consists of two interfascial injections of local anesthetics: 1) between the pectoralis minor and serratus anterior muscles, 2) between the pectoralis major and pectoralis minor muscles at the level of the third rib. Local anesthetic injection into these planes; It is expected to block the lateral pectoral nerve, medial pectoral nerve, anterior branches of the thoracic intercostal nerves, and long thoracic nerves (5). Recently, the types of local anesthesia used during radical surgery may decrease the postoperative pain levels and recovery times of the patients. The effect of these intraoperative or postoperative blocks on the patients' clinical status in the postoperative period has not been compared before.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Days
Official Title: The Effects of Intraoperative and Preoperative Interpectoral -Pectoserratus Plan Block on Postoperative Pain, Amount of Analgesic Use, and Shoulder Joint Range of Motion in Patients Who Had Breast Cancer Surgery
Estimated Study Start Date : October 6, 2022
Estimated Primary Completion Date : January 6, 2023
Estimated Study Completion Date : April 6, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Preoperative Interpectoral - Pectoserratus Plane Block
The block will be done by the Anesthesiologist.
Other: Preoperative Interpectoral - Pectoserratus Plane Block
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
The block will be made by the surgeon.
Other: Intraoperative Interpectoral - Pectoserratus Plane Block
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
will not be blocked.
Other: Non Block
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.




Primary Outcome Measures :
  1. Postoperative opioid consumption [ Time Frame: 24 hours ]
    Tramadol consumption in the first 24 hours after surgery


Secondary Outcome Measures :
  1. NRS scores [ Time Frame: 1., 2., 6., 12., 24. hour ]
    NRS scores in the first 24 hours after surgery

  2. Quality of Recovery [ Time Frame: 24th hours ]
    QoR-15 questionairre QoR-15 questionairre

  3. The disability levels of the patients due to shoulder dysfunction. [ Time Frame: 10th day ]
    The Shoulder Pain and Disability Index questionnaire will be used to determine The disability levels of the patients due to shoulder dysfunction. (Quick dash)

  4. Hand grip muscle strength. [ Time Frame: 24th hour, 10th day ]
    Hand grip muscle strength will be measured with a handheld dynamometer.

  5. Quality of Life (Short Form 36) [ Time Frame: 24th hour, 10th day ]
    The SF-36 Quality of Life scale will be used to assess quality of life.

  6. Shoulder joint range of motion [ Time Frame: 10th day ]
    Shoulder joint range of motion will be measured with a goniometer.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05568589


Contacts
Layout table for location contacts
Contact: Ömer Faruk Altaş, 1 +905366533992 omerfarukaltas@hotmail.com
Contact: Elif Umay Altaş, 2 +905053076622 elifumay.altas@bakircay.edu.tr

Locations
Layout table for location information
Turkey
Izmir Bakircay University Cigli Training and Research Hospital
İzmir, Turkey
Contact: Ömer Faruk ALTAŞ, 1         
Sponsors and Collaborators
Izmir Bakircay University
Investigators
Layout table for investigator information
Principal Investigator: Ömer Faruk Altaş, 1 İzmir Bakircay University
Layout table for additonal information
Responsible Party: Omer Faruk Altas, Specialist, Izmir Bakircay University
ClinicalTrials.gov Identifier: NCT05568589    
Other Study ID Numbers: 712
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Omer Faruk Altas, Izmir Bakircay University:
İnterpectoral plane block
Pectoserratus plane block
Breast Cancer
PECS II Block
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations