Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000271707
Ethics application status
Approved
Date submitted
16/03/2021
Date registered
14/02/2022
Date last updated
14/02/2022
Date data sharing statement initially provided
14/02/2022
Date results provided
14/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pectoral nerve blocks type II anesthesia for vascular port implantation
Scientific title
Evaluation of the effectiveness of modified pectoral nerve blocks type II (PECS II) anesthesia for vascular port implantation using cephalic vein cutdown (CVC) method
Secondary ID [1] 303702 0
None
Universal Trial Number (UTN)
U1111-1266-1435
Trial acronym

Linked study record


Health condition
Health condition(s) or problem(s) studied:
Perioperative Pain 321120 0
Regional anaesthesia 321121 0
Port-a-cath implantation 321122 0
Condition category
Condition code
Anaesthesiology 318914 318914 0 0
Pain management
Anaesthesiology 318915 318915 0 0
Anaesthetics
Cardiovascular 320532 320532 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Brief name: PECS II nerve block for venous access port implantation: retrospective and observational study.

Due to the observational and retrospective type of the study, all participants received these interventions regardless of their involvement in this study, and the data were taken from patients undergoing PECS II procedure for venous access port implantation from 1st Jan 2019 to 31st Dec 2020.

Venous access port implantation procedures are performed mainly by venipuncture of the right or left internal jugular vein, inserting a catheter into the superior vena cava, at the junction of the vein and the right atrium. The catheter is then tunnelled and connected to a port chamber implanted into the subcutaneous pocket in the ipsilateral subclavian region.

Venous access port implantation can also be done by venesection, inserting a catheter into one of the veins in the arm in the area of the deltoid-thoracic sulcus. In most cases, it is the cephalic vein. The port chamber is implanted into a subcutaneous pocket created in the ipsilateral subclavian region. This method eliminates the need for catheter tunnelling. A venous access port catheter can also be implanted by performing subclavian vein venipuncture.

Regardless of the technique, venous access port implantation procedures are performed under local infiltration anaesthesia, using a large volume of anaesthetic with adrenaline (about 30-40ml).

Pectoral Nerve Blocks type I and II (PECS I and II) are nerve blocks in the chest wall, an alternative to paravertebral block (PVB), commonly used as one of the elements of multimodal analgesia in thoracic procedures (mainly breast surgery).

PECS I is a nerve block, in which a local anaesthetic is deposited in the plane between the pectoralis major and the pectoralis minor, at the level of the third rib, blocking the lateral and medial pectoral nerves. PECS I can be used for procedures in the chest wall, drainage of the pleural cavity or for procedures limited to the pectoralis major muscle.

PECS II is a modification of the PECS I block, in which, after the deposition of the anaesthetic in the plane between the pectoral muscles, an additional dose of a local anaesthetic is administered between the pectoralis minor and the anterior dentate muscle, blocking the lateral branches of the T2 to T4 intercostal nerves, the intercostal-brachial nerve and the long thoracic nerve. PECS II can be used for the procedures described above as well as for more extensive breast surgery procedures (mastectomy, quadrantectomy). Then it is performed more laterally than the PECS I block (usually in the anterior axillary line). The ultrasound technique is used to identify the fascial spaces, with a linear probe (5-12 MHz). After the fascial spaces are identified, a 45 degree angle needle is inserted into them and a local anaesthetic is administered under the ultrasound guidance.

The aim of the study was to assess the effectiveness of PECS II block in anaesthesia for venous access port implantation through the cephalic vein venesection method, considering the volume of the local anaesthetic used and the comfort of the patient and the operator.

All the patients enrolled in the study were scheduled to undergo venous access port implantation by the cephalic vein venesection in the area of the deltoid-thoracic sulcus on the right or left side of the chest. The right side is the default side in order to shorten the length of the catheter. Port implantation is planned on the left side in the case of contraindications to implantation on the right side. Neither pharmacological premedication nor analgosedation was planned during the procedure. The implantation procedure was performed in a modified PECS II block by administering an anaesthetic under the ultrasound guidance between the fascia of the pectoralis major and the pectoralis minor, and between the fascia of the pectoralis minor and the dentate muscle, identifying the fascial structures more medially than in the classic method, i.e. around the mid-clavicular line. The intended volume of the anaesthetic (from 15-20 ml) was evenly deposited between the two compartments.

Venus access port implantation began with aseptic preparation of the surgical field. Just below the clavicle, the muscle groups were located with the help of an ultrasound head. After the structures had been identified under the ultrasound guidance, using an in-plane technique, a lead needle with a 22-gauge diameter and a length of 50mm was inserted parallel to the clavicle towards the head of the humerus at an angle of 30-45 degrees. After confirming that the intended space had been reached, 8-10 ml of the anaesthetic was deposited in a volume sufficient to dissect the fascia laminae to a width of minimum 4 cm, thus anaesthetising the neurovascular structures located there. The deeper structures were then anaesthetised with the same volume of the analgesic.

In the venesection of the vein in the deltoid-thoracic sulcus, it is necessary to anaesthetise the deeper anatomical structures, which is why PECS type II method was selected.

Due to the insufficient anaesthesia of the skin, frequently occurring with PECS II, before the incision infiltration anaesthesia of the incision line was performed, with the use of 0.5% lignocaine with 0.005% adrenaline in a volume of 3 ml. Subsequently, in the deltoid-thoracic groove, the cephalic vein venesection was performed and, under fluoroscopy, a vascular catheter was inserted into the vein, with its tip placed into the superior vena cava at the junction with the right atrium. Then the catheter was connected with the port chamber implanted into the created subcutaneous pocket of the pectoralis major fascia.

The above-mentioned procedures were performed by the following persons: an anaesthesiology and intensive care specialist with extensive experience of venous access port implantation and a resident doctor in the fourth year of training in anaesthesiology and intensive care under the supervision of the specialist doctor, with basic skills in the field of venous access port implementation and three years of experience in performing regional blocks.

During a postoperative examination connected with the removal of sutures on day 8 after the procedure or flushing the port before starting the scheduled chemotherapy, the patients were asked by a nurse about the pain intensity 24 hours after the procedure, the satisfaction assessment by means of the QoR-15 score or about the occurrence of side effects. Early complications are defined as occurring up to 7 days after the procedure.

The operator’s comfort was assessed on a 3-point scale created by the operators (Operator's Condition Assessment Score), considering the duration of the procedure, cooperation with the patient/ stability of the surgical field, the presence of pain complaints during the procedure and the related necessity to give local anaesthetic intraoperatively. The responses were rated on a scale of 0-2, with 0 meaning a good operator rating, 1 an acceptable rating and 2 a rating difficult to accept. The research protocol included age, sex, body weight, body height, BMI, the volume of local anaesthetic used, duration of anaesthesia and the procedure, preoperative ASA assessment, a technique used to perform the procedure, patient’s NRS assessment at measurement points, the result of the operator’s comfort assessment on the Operator’s Condition Assessment scale.
Intervention code [1] 320004 0
Diagnosis / Prognosis
Intervention code [2] 320005 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326854 0
The severity of pain assessed by the patient by means of the Numerical Rating Scale (NRS) in patients during procedures performed by the specialist and resident doctor
Timepoint [1] 326854 0
Intraoperatively: 1. skin incision, 2. cephalic vein preparation, 3. chamber pocket preparation, 4. dressing application
Primary outcome [2] 326855 0
The quality of postoperative recovery assessed by the patient by means of the Quality-of-Recovery 15 (QoR-15) score in patients with procedures performed by the specialist and resident doctor
Timepoint [2] 326855 0
Baseline, postoperative 24 hours
Secondary outcome [1] 392888 0
The operator’s comfort assessment after performing PECS II block for the cephalic vein venesection procedure using the Operator's Condition Assessment Score.
Timepoint [1] 392888 0
Intraoperatively: 1. skin incision, 2. cephalic vein preparation, 3. chamber pocket preparation, 4. dressing application

Eligibility
Key inclusion criteria
1. Patients qualified for port-a-cath implantation
2. Age between 18-90 years old
3. The obtained informed and written consent to participate in the study
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No acceptance for regional anesthesia
2. Allergy to local anaesthetics
3. Serious coagulopathy PLT <50x10^3, INR>2.5 APTT>40sec
4. Infection in puncture area

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Continuously distributed data will be tested for normality and measures of central tendency will be analyzed. Normally distributed data will be expressed as means and standard deviations and compared using a Student t-test; non-normally distributed data will be expressed as medians (interquartile range, IQR) and compared using the Mann-Whitney U test. Categorical variables will be described as proportions and compared using the chi-squared test or the Fisher Exact test. The strength of the relationship will be evaluated with the Spearman rank correlation coefficient. All p-values of less than 0.05 will be treated as indicative as statistical significance and no correction for multiplicity of testing will be undertaken due to the exploratory nature of the study. The study will be reported using the CONSORT guidelines. Analyses will be performed using GraphPad Prism (version 7.00 for Mac, GraphPad Software, La Jolla California USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2021
Date of last participant enrolment
Anticipated
Actual
24/12/2021
Date of last data collection
Anticipated
Actual
31/12/2021
Sample size
Target
100
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 23538 0
Poland
State/province [1] 23538 0
Lower Silesia

Funding & Sponsors
Funding source category [1] 308117 0
Hospital
Name [1] 308117 0
4th Military Hospital of Wroclaw
Country [1] 308117 0
Poland
Primary sponsor type
Individual
Name
Jaroslaw Janc, MD, PhD
Address
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw
Country
Poland
Secondary sponsor category [1] 308871 0
Individual
Name [1] 308871 0
Marek Szamborski, MD
Address [1] 308871 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw
Country [1] 308871 0
Poland
Secondary sponsor category [2] 308872 0
Individual
Name [2] 308872 0
Patrycja Lesnik, MD, PhD
Address [2] 308872 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw
Country [2] 308872 0
Poland
Other collaborator category [1] 281688 0
Individual
Name [1] 281688 0
Lidia Lysenko, MD, PhD
Address [1] 281688 0
Department of Anaesthesiology and Intensive Therapy, Wroclaw Medical University, Borowska 213, 50-529 Wroclaw
Country [1] 281688 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308103 0
Bioethics Committee at The Military Medical Chamber in Warsaw
Ethics committee address [1] 308103 0
Ethics committee country [1] 308103 0
Poland
Date submitted for ethics approval [1] 308103 0
04/01/2021
Approval date [1] 308103 0
26/01/2021
Ethics approval number [1] 308103 0
KB–1/21

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109546 0
Dr Jaroslaw Janc, MD, PhD
Address 109546 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country 109546 0
Poland
Phone 109546 0
+48 608 188 381
Fax 109546 0
Email 109546 0
[email protected]
Contact person for public queries
Name 109547 0
Marek Szamborski, MD
Address 109547 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country 109547 0
Poland
Phone 109547 0
+48 71 712 89 39
Fax 109547 0
Email 109547 0
[email protected]
Contact person for scientific queries
Name 109548 0
Patrycja Lesnik, MD, PhD
Address 109548 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country 109548 0
Poland
Phone 109548 0
+48 71 712 89 39
Fax 109548 0
Email 109548 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication and available for 5 years after publication
Available to whom?
Only to researchers who provide a methodologically relevant explanation
Available for what types of analyses?
Only to achieve the purposes of the approved request
How or where can data be obtained?
The data can be obtained by emailing the principal investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11022Ethical approval    381622-(Uploaded-16-03-2021-00-50-14)-Study-related document.pdf



Results publications and other study-related documents

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