Sacral Erector Spinae Plane BlockNCT07534488
Sacral Erector Spinae Plane Block in Pilonidal Sinus Surgery
A study testing Sacral Erector Spinae Plane Block and Standard Postoperative Analgesia in people with Sacral Erector Spinae Plane Block and Pilonidal Sinus, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block for postoperative analgesia management in patients undergoing pilonidal sinus surgery under general anesthesia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sacral Erector Spinae Plane Block, Pilonidal Sinus
- What is being tested?
- Sacral Erector Spinae Plane Block and Standard Postoperative Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective pilonidal sinus surgery.
- ASA physical status I and II
Who cannot join
- Allergy or sensitivity to local anesthetics or opioid drugs.
- Infection at the block site.
- Alcohol or drug addiction.
- Use of anticoagulant agents.
- Patient refusal.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University
Istanbul
Burak Ömür, +905056215056, bomur@medipol.edu.tr
About this study
Official title: Evaluation of the Efficacy of Ultrasound-Guided Sacral Erector Spinae Plane Block in Postoperative Analgesia Management in Patients Undergoing Pilonidal Sinus Surgery
This study aims to evaluate the efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block for postoperative analgesia management in patients undergoing pilonidal sinus surgery under general anesthesia
Read the detailed description
Severe pain after pilonidal sinus surgery is a significant problem that reduces patient comfort. In this randomized, prospective study, patients will be divided into two groups (Sacral ESPB group and control group) using a computer randomization method before the surgery. In the Sacral ESPB group, the block will be performed under ultrasound guidance using a 20 ml local anesthetic volume immediately after the surgical procedure and before extubation. The study will compare postoperative rescue analgesic requirement, opioid consumption, pain scores (NRS), and the incidence of side effects and complications
- Conditions
- Sacral Erector Spinae Plane Block, Pilonidal Sinus
- Being tested
- Sacral Erector Spinae Plane Block, Standard Postoperative Analgesia
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral Erector Spinae Plane BlockProcedure or surgery
Immediately after the surgical procedure and before extubation, ultrasound-guided (Vivid Q) Sacral ESPB will be applied to the patient in the prone position using a total volume of 20 ml.
Standard Postoperative AnalgesiaDrug
No block will be applied to this group. Both groups will receive intravenous 400 mg ibuprofen and 100 mg tramadol 20 minutes before the end of the surgery, and routine 1000 mg paracetamol every 8 hours postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Sacral ESPB Group | Experimental | Not described Receives: Procedure: Sacral Erector Spinae Plane Block |
| Control Group | Active comparator | Not described Receives: Drug: Standard Postoperative Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative rescue analgesic (opioid) consumption.
Total amount of intravenous tramadol administered as a rescue analgesic will be recorded
Measured: At 24 hours postoperatively (Cumulative total over the 24-hour period)
Secondary outcomes (2)
Postoperative pain scores evaluated by the Numeric Rating Scale (NRS)
Pain scores will be evaluated at rest and during movement using a 0-10 NRS (0= no pain, 10= most severe pain).
Measured: At 1, 3, 6, 12, 18, and 24 hours postoperatively.
Incidence of opioid-related side effects and block-related complications.
Occurrence of side effects such as nausea, vomiting, itching, allergic reactions, and complications like hematoma will be recorded.
Measured: During the 24-hour postoperative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 Apr 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacral Erector Spinae Plane BlockStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Omur, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534488
- Sponsor's protocol ID
- Medipol 374, 20.03.2025
- Status last verified
- Jul 2026
- First submitted
- 9 Apr 2026
- Last updated
- 27 Jul 2026
- 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Ultrasound-Guided Sacral Erector Spinae Plane Block in Postoperative Analgesia Management in Patients Undergoing Pilonidal Sinus Surgery
- ClinicalTrials.gov ID
- NCT07534488
- Acronym / sponsor ID
- Medipol 374, 20.03.2025
- Conditions
- Sacral Erector Spinae Plane Block, Pilonidal Sinus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 16 Apr 2026 (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.
This study aims to evaluate the efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block for postoperative analgesia management in patients undergoing pilonidal sinus surgery under general anesthesia
Detailed description
Severe pain after pilonidal sinus surgery is a significant problem that reduces patient comfort. In this randomized, prospective study, patients will be divided into two groups (Sacral ESPB group and control group) using a computer randomization method before the surgery. In the Sacral ESPB group, the block will be performed under ultrasound guidance using a 20 ml local anesthetic volume immediately after the surgical procedure and before extubation. The study will compare postoperative rescue analgesic requirement, opioid consumption, pain scores (NRS), and the incidence of side effects and complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacral ESPB Group | Experimental | Procedure: Sacral Erector Spinae Plane Block |
| Control Group | Active comparator | Drug: Standard Postoperative Analgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective pilonidal sinus surgery.
- ASA physical status I and II
Key exclusion criteria (5 listed)
- Allergy or sensitivity to local anesthetics or opioid drugs.
- Infection at the block site.
- Alcohol or drug addiction.
- Use of anticoagulant agents.
- Patient refusal.
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 |
|---|---|---|
| Sacral Erector Spinae Plane BlockImmediately after the surgical procedure and before extubation, ultrasound-guided (Vivid Q) Sacral ESPB will be applied to the patient in the prone position using a total volume of 20 ml. | Procedure or surgery | Sacral ESPB Group |
| Standard Postoperative AnalgesiaNo block will be applied to this group. Both groups will receive intravenous 400 mg ibuprofen and 100 mg tramadol 20 minutes before the end of the surgery, and routine 1000 mg paracetamol every 8 hours postoperatively | Drug | Control Group |
Primary outcome
Total postoperative rescue analgesic (opioid) consumption.
Time frame: At 24 hours postoperatively (Cumulative total over the 24-hour period)
Total amount of intravenous tramadol administered as a rescue analgesic will be recorded
2 secondary outcomes
Postoperative pain scores evaluated by the Numeric Rating Scale (NRS)
Time frame: At 1, 3, 6, 12, 18, and 24 hours postoperatively.
Incidence of opioid-related side effects and block-related complications.
Time frame: During the 24-hour postoperative period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral Erector Spinae Plane Block and Standard Postoperative Analgesia in people with Sacral Erector Spinae Plane Block and Pilonidal Sinus, run by Medipol 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total postoperative rescue analgesic (opioid) consumption. (time frame: At 24 hours postoperatively (Cumulative total over the 24-hour period)). 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 27 Jul 2026.