Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05568589
Other study ID # 712
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 6, 2022
Est. completion date April 6, 2023

Study information

Verified date October 2022
Source Izmir Bakircay University
Contact Ömer Faruk Altas, 1
Phone +905366533992
Email omerfarukaltas@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date April 6, 2023
Est. primary completion date January 6, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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
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.

Locations

Country Name City State
Turkey Izmir Bakircay University Cigli Training and Research Hospital Izmir

Sponsors (1)

Lead Sponsor Collaborator
Izmir Bakircay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative opioid consumption Tramadol consumption in the first 24 hours after surgery 24 hours
Secondary NRS scores NRS scores in the first 24 hours after surgery 1., 2., 6., 12., 24. hour
Secondary Quality of Recovery QoR-15 questionairre QoR-15 questionairre 24th hours
Secondary The disability levels of the patients due to shoulder dysfunction. The Shoulder Pain and Disability Index questionnaire will be used to determine The disability levels of the patients due to shoulder dysfunction. (Quick dash) 10th day
Secondary Hand grip muscle strength. Hand grip muscle strength will be measured with a handheld dynamometer. 24th hour, 10th day
Secondary Quality of Life (Short Form 36) The SF-36 Quality of Life scale will be used to assess quality of life. 24th hour, 10th day
Secondary Shoulder joint range of motion Shoulder joint range of motion will be measured with a goniometer. 10th day
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A