Trial Title:
Effects of Interpectoral-Pectoserratus Plane Block After Breast Cancer Surgery
NCT ID:
NCT05568589
Condition:
Pain, Postoperative
Disability Physical
Quality of Life
Conditions: Official terms:
Pain, Postoperative
Conditions: Keywords:
İnterpectoral plane block
Pectoserratus plane block
Breast Cancer
PECS II Block
Study type:
Observational [Patient Registry]
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Preoperative Interpectoral - Pectoserratus Plane Block
Description:
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.
Arm group label:
Preoperative Interpectoral - Pectoserratus Plane Block
Intervention type:
Other
Intervention name:
Intraoperative Interpectoral - Pectoserratus Plane Block
Description:
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.
Arm group label:
Intraoperative Interpectoral - Pectoserratus Plane Block
Intervention type:
Other
Intervention name:
Non Block
Description:
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.
Arm group label:
Non Block
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Izmir Bakircay University Cigli Training and Research Hospital
Address:
City:
İzmir
Country:
Turkey
Contact:
Last name:
Ömer Faruk ALTAŞ, 1
Start date:
October 6, 2022
Completion date:
April 6, 2023
Lead sponsor:
Agency:
Izmir Bakircay University
Agency class:
Other
Source:
Izmir Bakircay University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05568589
