Health TrialsbyHealthPanel

Sacral Erector Spinae Plane Block in Pilonidal Sinus Surgery

ConditionsSacral Erector Spinae Plane BlockPilonidal Sinus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedipol University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for elective pilonidal sinus surgery.

ASA physical status I and II

Disqualifiers

Allergy or sensitivity to local anesthetics or opioid drugs.

Infection at the block site.

Alcohol or drug addiction.

Use of anticoagulant agents.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sacral Erector Spinae Plane Block

    Procedure/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 Analgesia

    Drug

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Sacral ESPB GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total postoperative rescue analgesic (opioid) consumption.

Total amount of intravenous tramadol administered as a rescue analgesic will be recorded

Time frame
At 24 hours postoperatively (Cumulative total over the 24-hour period)

Secondary outcomes

1

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).

Time frame
At 1, 3, 6, 12, 18, and 24 hours postoperatively.
2

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.

Time frame
During the 24-hour postoperative period.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medipol University

Lead sponsor

Source ClinicalTrials.gov
Apply now