PainNCT05697315
Erector Spinae Plane Block for Postoperative Pain Management
A study testing Erector spinae plane block in people with Pain and Post Operative Pain, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block after cesarean section (CS) with Pfannenstiel incision under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Post Operative Pain
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Apr 2022
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA II patients
- 18-45 years who underwent CS with Pfannenstiel incision under spinal anesthesia
- agreed to participate in the study
Who cannot join
- Patients with infection at the injection site
- Coagulopathy Allergy to amide-type local anesthetics
- History of peripheral neuropathy
- Hepatic and/or renal failure
- Refusing the procedure
- patients with heart disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş, 46100
About this study
Official title: The Effect of Erector Spinae Block for Postoperative Pain Management Cesarean Delivery Patients
Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block after cesarean section (CS) with Pfannenstiel incision under spinal anesthesia.
Read the detailed description
The study included 54 patients with mild systemic disease (ASA II patients) who would undergo elective CS under spinal anesthesia. They were randomly divided into an ESP block group (Group E) and a control group (Group C). After the surgery, Group E patients underwent ultrasound-guided bilateral ESP block with 20 ml of 0.25% bupivacaine at the lateral decubitus position, while Group C received no intervention. Patients in both groups received parenteral patient-controlled analgesia. The patients' post-operative 24-hour opioid consumption, regular Visual Analogue Scale (VAS) measurements, and need for rescue analgesics were evaluated. Statistical analysis was performed using SPSS 21 program. Demographic and other data were assessed using independent samples t-test, Mann-Whitney U test, and Chi-square analysis.
- Conditions
- Pain, Post Operative Pain
- Being tested
- Control, Erector spinae plane block
- Keywords
- Pain, postoperative analgesia, Erector spinae plane block, cesarean section
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
No block was performed
Erector spinae plane blockProcedure or surgery
Erector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | No block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward. Receives: Procedure: Control |
| Erector spinae plane block | Active comparator | Erector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward. Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour opioid consumption
The amount of tramadol consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.
Measured: up to 24 hour
Secondary outcomes (1)
Visual Analog Scale (Vas)
pain scores,graded from 0 to 10, 0 no pain, 10 highest pain experienced
Measured: 0, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Dec 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökçe Gişi, Kahramanmaras Sutcu Imam University
- Investigators
- Gökçe Gişi, Principal investigator, Kahramanmaras Sutcu Imam University Hospital Kahramanmaras, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697315
- Sponsor's protocol ID
- 2021-02-03
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erector Spinae Block for Postoperative Pain Management Cesarean Delivery Patients
- ClinicalTrials.gov ID
- NCT05697315
- Acronym / sponsor ID
- 2021-02-03
- Conditions
- Pain, Post Operative Pain
- Keywords
- Pain, postoperative analgesia, Erector spinae plane block, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 25 Jan 2023 (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.
Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block after cesarean section (CS) with Pfannenstiel incision under spinal anesthesia.
Detailed description
The study included 54 patients with mild systemic disease (ASA II patients) who would undergo elective CS under spinal anesthesia. They were randomly divided into an ESP block group (Group E) and a control group (Group C). After the surgery, Group E patients underwent ultrasound-guided bilateral ESP block with 20 ml of 0.25% bupivacaine at the lateral decubitus position, while Group C received no intervention. Patients in both groups received parenteral patient-controlled analgesia. The patients' post-operative 24-hour opioid consumption, regular Visual Analogue Scale (VAS) measurements, and need for rescue analgesics were evaluated. Statistical analysis was performed using SPSS 21 program. Demographic and other data were assessed using independent samples t-test, Mann-Whitney U test, and Chi-square analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Procedure: ControlNo block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward. |
| Erector spinae plane block | Active comparator | Procedure: Erector spinae plane blockErector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA II patients
- 18-45 years who underwent CS with Pfannenstiel incision under spinal anesthesia
- agreed to participate in the study
Key exclusion criteria (6 listed)
- Patients with infection at the injection site
- Coagulopathy Allergy to amide-type local anesthetics
- History of peripheral neuropathy
- Hepatic and/or renal failure
- Refusing the procedure
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 |
|---|---|---|
| ControlNo block was performed | Procedure or surgery | Control group |
| Erector spinae plane blockErector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward. | Procedure or surgery | Erector spinae plane block |
Primary outcome
24-hour opioid consumption
Time frame: up to 24 hour
The amount of tramadol consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.
1 secondary outcome
Visual Analog Scale (Vas)
Time frame: 0, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
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 25 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
Gökçe Gişi principal investigator
Kahramanmaras Sutcu Imam University Hospital Kahramanmaras, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block in people with Pain and Post Operative Pain, run by Kahramanmaras Sutcu Imam 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 6 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 25 Jan 2023. 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. Some participants in this study may receive a placebo. 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?
24-hour opioid consumption (time frame: up to 24 hour). 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 25 Jan 2023.