Postoperative PainPhase 4NCT03619447
Comparison of ESP Block Versus Serratus Block
A Phase 4 study testing ESP block group and serratus block group in people with Postoperative Pain, run by Cukurova University.
Trial summary
Total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit to the study. The patients randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ESP block group and serratus block group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2018to 15 Apr 2019
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-II patients
- Being volunteer
- Total mastectomy
Who cannot join
- ASA III and over
- Renal and hepatic failure
- Non Volunteers
- Emergency procedures
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Ultrasound Guided Erector Spinae Plane Block Versus Serratus Plane Block in Totally Mastectomy
Total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit to the study. The patients randomly divided into two groups. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).
Read the detailed description
In this study, total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit. Using with computer randomisation, the patients allocate into two groups. Anaesthesia induction will perform with 2 mg/kg propofol, 0.6 mg/kg rocuronium and 2 microgram/kg fentanil and general anaesthesia will maintain with sevoflurane %1-2 +%40-60 O2-N20 mixture and remifentanil infusion. All of the blocks will perform under general anaesthesia. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain, analgesic requirement and complications will evaluate. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).
- Conditions
- Postoperative Pain
- Being tested
- ESP block group, serratus block group
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP block groupDrug
Also called USG guided ESP block group
USG guided Erector spinae block (ESP) will perform bilaterally.
serratus block groupDrug
Also called USG guided serratus plane block
USG guided serratus plane block will perform bilaterally
| Study group | Role | What they receive |
|---|---|---|
| ESP block group | Active comparator | Under general anaesthesia, Ultrasound guided ESP block will perform at the T6 level with15 ml bupivacain+ 5ml lidocaine, bilaterally. Morphine 0.1 mg/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with morphine will apply to the all patients. Postoperative pain assessment and morphine consumption will record till the postoperative 24 th hours. Receives: Drug: ESP block group |
| serratus block group | Active comparator | Under general anaesthesia, Ultrasound guided SAP block will perform at the T6 level with15 ml bupivacain+ 5ml lidocaine, bilaterally. Morphine 0.1 mg/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with morphine will apply to the all patients. Postoperative pain assessment and morphine consumption will record till the postoperative 24 th hours. Receives: Drug: serratus block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
Patient controlled analgesia (PCA) will provide with morphine PCA. Total morphine consumption will calculate and record till the postoperative 24th hours.
Measured: up to postoperative 24th hours.
Secondary outcomes (1)
numerical rating scale score
Postoperative pain assessment will apply with 11-point numerical rating scale. These scores will record till the postoperative 24 th hours.
Measured: up to postoperative 24th hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start15 Sep 2018 (estimated)
- Primary completion15 Mar 2019 (estimated)
- Study completion15 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebru biricik, Cukurova University
- Investigators
- Ebru Biricik, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619447
- Sponsor's protocol ID
- ESP vs Serratus
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ultrasound Guided Erector Spinae Plane Block Versus Serratus Plane Block in Totally Mastectomy
- ClinicalTrials.gov ID
- NCT03619447
- Acronym / sponsor ID
- ESP vs Serratus
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (estimated)
- Primary completion
- 15 Mar 2019 (estimated)
- Study completion
- 15 Apr 2019 (estimated)
- First posted
- 7 Aug 2018 (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.
Total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit to the study. The patients randomly divided into two groups. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).
Detailed description
In this study, total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit. Using with computer randomisation, the patients allocate into two groups. Anaesthesia induction will perform with 2 mg/kg propofol, 0.6 mg/kg rocuronium and 2 microgram/kg fentanil and general anaesthesia will maintain with sevoflurane %1-2 +%40-60 O2-N20 mixture and remifentanil infusion. All of the blocks will perform under general anaesthesia. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain, analgesic requirement and complications will evaluate. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP block group | Active comparator | Drug: ESP block groupUnder general anaesthesia, Ultrasound guided ESP block will perform at the T6 level with15 ml bupivacain+ 5ml lidocaine, bilaterally. Morphine 0.1 mg/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with morphine will apply to the all patients. Postoperative pain assessment and morphine consumption will record till the postoperative 24 th hours. |
| serratus block group | Active comparator | Drug: serratus block groupUnder general anaesthesia, Ultrasound guided SAP block will perform at the T6 level with15 ml bupivacain+ 5ml lidocaine, bilaterally. Morphine 0.1 mg/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with morphine will apply to the all patients. Postoperative pain assessment and morphine consumption will record till the postoperative 24 th hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II patients
- Being volunteer
- Total mastectomy
Key exclusion criteria (4 listed)
- ASA III and over
- Renal and hepatic failure
- Non Volunteers
- Emergency procedures
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 |
|---|---|---|
| ESP block groupAlso: USG guided ESP block groupUSG guided Erector spinae block (ESP) will perform bilaterally. | Drug | ESP block group |
| serratus block groupAlso: USG guided serratus plane blockUSG guided serratus plane block will perform bilaterally | Drug | serratus block group |
Primary outcome
morphine consumption
Time frame: up to postoperative 24th hours.
Patient controlled analgesia (PCA) will provide with morphine PCA. Total morphine consumption will calculate and record till the postoperative 24th hours.
1 secondary outcome
numerical rating scale score
Time frame: up to postoperative 24th hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
Not yet recruitingObservational study
Impact of Parasternal and Rectointercostal Blocks on Extubation Time
Postoperative Pain, Extubation Time
RecruitingObservational study
Quality of Life and Pain After Appendectomy in Children
Chronic Pain, Postoperative, Quality of Life
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Not yet recruiting
Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
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.
Ebru Biricik principal investigator
Cukurova University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ESP block group and serratus block group in people with Postoperative Pain, run by Cukurova University.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebru Biricik (05052420223, ebrubiricik01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine consumption (time frame: up to postoperative 24th hours.). 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 7 Aug 2018.