Catheter; Pain (Indwelling Catheter)NCT04170699
Effects of PECS 1 Block on Venous Cancer Port Catheter
A study testing Port-a-cath replacement in people with Catheter; Pain (Indwelling Catheter), run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
In this study our aim is to investigate the effects of ultrasound (USG) guided pectoral block (PECS) type 1 in the administration of an implanted port-a-cath . Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Catheter; Pain (Indwelling Catheter)
- What is being tested?
- Port-a-cath replacement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages between 18- 75
- ASA (American Society of Anesthesiologists) Score I-IV
- Undergoing elective port-a-cath replacemnet
Who cannot join
- Patients with neurological deficits
- Patients who have major vascular damage at the same side
- Mentally retarded patients
- Patients with alcohol or drug addiction
- Patients who are allergic to local anesthetics
- Pregnancy
Show all 10Show fewer
- Paitents with coagulopathy
- Patients with skin infection at the side of the procedure
- Patients with pneumothorax at the side of the procedure
- Patient with a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ultrasound Guided Pectoral Blok Type 1 on Subcutaneous Port Catheter Replacement : A Randomized Controlled Study
In this study our aim is to investigate the effects of ultrasound (USG) guided pectoral block (PECS) type 1 in the administration of an implanted port-a-cath .
Read the detailed description
Cancer is one of the most important reasons of mortality in the world. There are a lot of different types of treatments for cancer and so far chemotherapy is the most common one. However, chemotherapy damages the peripheral veins, so implanted subcutaneous port-a-caths are used as an alternative. Traditionally this implantation is adminstered with infiltrative anesthesia. Recently, USG is used in anesthesia practice world wide. Blanco R et all (1) defined PECS 1 block as an alternative to paravertebral block. PECS 1 block aims to anesthetize the medial and lateral pectoral nerves. In this study our aim is to investigate the effects of USG guided PECS 1 block in the administiration of an implanted port-a-cath .
- Conditions
- Catheter; Pain (Indwelling Catheter)
- Being tested
- Port-a-cath replacement
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Port-a-cath replacementProcedure or surgery
Implantation of a subcutaneous venous port-a-cath
| Study group | Role | What they receive |
|---|---|---|
| PECS 1 Block | Experimental | 40 patients who had PECS 1 block for peroperative analgesia in port-a-cath replacement. All patients will receive IV Midazolam (0.05mg/kg) premedication. Standard monitorization of EKG, non- invasive blood pressure and pulseoximeter will be done and recorded in every 5 minutes. After sedation and standard monitorization, 20 minutes before the intervention and in the supine positon the PECS 1 block will be done. 10 % povidone - iodin will be used for sterilization and the USG probe will be covered with sterile sheath. The block will be done as a single injection of local anaesthetic between pectoralis major and pectoralis minor muscles at the level of the 3rd rib to anaesthetise the lateral and medial pectoral nerves. The USG probe will be replaced inferior to the clavicle. Identify the pectoralis muscles with the axillary artery and axillary vein on sonography. The brachial plexus should be visible underneath. After confirmation with 20 mL %0.25 bupivacaine will be administered. Receives: Procedure: Port-a-cath replacement |
| Infiltrative Anesthesia | Experimental | 40 patients who had port-cath replacement will receive infiltrative anesthesia. Receives: Procedure: Port-a-cath replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative and postoperative analgesic needs of patients
Our primary outcome is to measure and identify the analgesic needs of the patients at the perioperative and postoperative period.In order to measure the analgesic needs Visual Analogue Scale will be used and patients' pain scores will be measured.
Measured: Change in Visual analog Scale (VAS) scores ( between 1 and 10, a higher score represents greater pain intensity. ) at the 1st, 3rd, 6th, 12th and 24th hours after the procedure.
Secondary outcomes (1)
Hemodynamic parameters at the perioperative and postoperative period
Our secondary outcome is to measure the hemodynamic parameters such as systolic and diastolic arterial pressure at the perioperative and postoperative period.
Measured: 1st, 3rd, 6th,12th and 24th hours after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter; Pain (Indwelling Catheter)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a two-arm parallel assignment. One group will receive PECS 1 block and the other will receive infiltrative anesthesia.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OZCAN PISKIN, MD, Bulent Ecevit University
- Investigators
- OZCAN PISKIN, M.D., Principal investigator, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170699
- Sponsor's protocol ID
- 2019-78-08/05
- Status last verified
- Feb 2021
- First submitted
- 13 Nov 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound Guided Pectoral Blok Type 1 on Subcutaneous Port Catheter Replacement : A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04170699
- Acronym / sponsor ID
- 2019-78-08/05
- Conditions
- Catheter; Pain (Indwelling Catheter)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study our aim is to investigate the effects of ultrasound (USG) guided pectoral block (PECS) type 1 in the administration of an implanted port-a-cath .
Detailed description
Cancer is one of the most important reasons of mortality in the world. There are a lot of different types of treatments for cancer and so far chemotherapy is the most common one. However, chemotherapy damages the peripheral veins, so implanted subcutaneous port-a-caths are used as an alternative. Traditionally this implantation is adminstered with infiltrative anesthesia. Recently, USG is used in anesthesia practice world wide. Blanco R et all (1) defined PECS 1 block as an alternative to paravertebral block. PECS 1 block aims to anesthetize the medial and lateral pectoral nerves. In this study our aim is to investigate the effects of USG guided PECS 1 block in the administiration of an implanted port-a-cath .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will be a two-arm parallel assignment. One group will receive PECS 1 block and the other will receive infiltrative anesthesia.
| Arm | Type | Receives |
|---|---|---|
| PECS 1 Block | Experimental | Procedure: Port-a-cath replacement40 patients who had PECS 1 block for peroperative analgesia in port-a-cath replacement. All patients will receive IV Midazolam (0.05mg/kg) premedication. Standard monitorization of EKG, non- invasive blood pressure and pulseoximeter will be done and recorded in every 5 minutes. After sedation and standard monitorization, 20 minutes before the intervention and in the supine positon the PECS 1 block will be done. 10 % povidone - iodin will be used for sterilization and the USG probe will be covered with sterile sheath. The block will be done as a single injection of local anaesthetic between pectoralis major and pectoralis minor muscles at the level of the 3rd rib to anaesthetise the lateral and medial pectoral nerves. The USG probe will be replaced inferior to the clavicle. Identify the pectoralis muscles with the axillary artery and axillary vein on sonography. The brachial plexus should be visible underneath. After confirmation with 20 mL %0.25 bupivacaine will be administered. |
| Infiltrative Anesthesia | Experimental | Procedure: Port-a-cath replacement40 patients who had port-cath replacement will receive infiltrative anesthesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages between 18- 75
- ASA (American Society of Anesthesiologists) Score I-IV
- Undergoing elective port-a-cath replacemnet
Key exclusion criteria (10 listed)
- Patients with neurological deficits
- Patients who have major vascular damage at the same side
- Mentally retarded patients
- Patients with alcohol or drug addiction
- Patients who are allergic to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Port-a-cath replacementImplantation of a subcutaneous venous port-a-cath | Procedure or surgery | Infiltrative Anesthesia, PECS 1 Block |
Primary outcome
Perioperative and postoperative analgesic needs of patients
Time frame: Change in Visual analog Scale (VAS) scores ( between 1 and 10, a higher score represents greater pain intensity. ) at the 1st, 3rd, 6th, 12th and 24th hours after the procedure.
Our primary outcome is to measure and identify the analgesic needs of the patients at the perioperative and postoperative period.In order to measure the analgesic needs Visual Analogue Scale will be used and patients' pain scores will be measured.
1 secondary outcome
Hemodynamic parameters at the perioperative and postoperative period
Time frame: 1st, 3rd, 6th,12th and 24th hours after the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
OZCAN PISKIN, M.D. principal investigator
Bulent Ecevit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Port-a-cath replacement in people with Catheter; Pain (Indwelling Catheter), run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative and postoperative analgesic needs of patients (time frame: Change in Visual analog Scale (VAS) scores ( between 1 and 10, a higher score represents greater pain intensity. ) at the 1st, 3rd, 6th, 12th and 24th hours after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.