Ultrasound Guided Sacral Erector Spinae Plane Block in vNOTES Surgery
Ltrasound Guided Sacral Erector Spinae Plane Block in vNOTES Surgery
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 18-65
- Planned for elective vNOTES surgery
- ASA 1-3
- BMI <35
Exclusion Criteria:
- ASA 4
- Planned emergency surgery
- Pregnant patients
- Persons with coagulopathy
- Persons with allergy to local anesthetics
- Persons with neurological disease
- Persons with infection in the area where the block will be performed
- Persons who refuse to participate in the study for any reason
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: General anesthesia
Intraoperative remifentanil consumption will be recorded after standard general anesthesia induction.
If heart rate and mean arterial pressure change by more than 20% from baseline, the remifentanil dose will be increased or decreased by 0.02-0.03
mcg/kg/min (Stepwise remifentanil titration protocol).
Heart rate and mean arterial pressure values will be recorded during colpotomy and uterine traction.
All patients will receive a standard analgesia protocol: 1 gram of paracetamol every 8 hours, 1 mg/kg of diclofenac every 12 hours, and 50 mg of tramadol as rescue analgesia if VAS > 4. The total tramadol dose consumed will be recorded.
Postoperative NRS scores at 0, 2, 6, 12, and 24 hours will be recorded (0: No pain, 10: Unbearable pain).
Postoperative nausea, vomiting, and adverse events will also be recorded.
|
Patients scheduled for vNOTES surgery will be divided into two groups: general anesthesia and general anesthesia + sacral ESP block.
Intraoperative opioid consumption and other parameters of the patients will be recorded.
|
|
Active Comparator: General anesthesia + Sacral ESP block
Bilateral S2 level sacral ESP block will be performed under ultrasound guidance.
A total of 20 ml of block solution will be administered to one side, consisting of 10 ml of 0.5% bupivacaine, 5 ml of 2% lidocaine, and 5 ml of saline.
Intraoperative remifentanil consumption will be recorded after standard general anesthesia induction.
If heart rate and mean arterial pressure change by more than 20% from baseline, the remifentanil dose will be increased or decreased by 0.02-0.03
mcg/kg/min (Stepwise remifentanil titration protocol).
Heart rate and mean arterial pressure values will be recorded during colpotomy and uterine traction.
All patients will receive a standard analgesia protocol: 1 gram of paracetamol every 8 hours, 1 mg/kg of diclofenac every 12 hours, and 50 mg of tramadol as rescue analgesia if VAS > 4. The total tramadol dose consumed will be recorded.
Postoperative NRS scores will be recorded at 0, 2, 6, 12, and 24 hours (0: No pain, 10: Unbearable pain).
Postoperative nau
|
Patients scheduled for vNOTES surgery will be divided into two groups: general anesthesia and general anesthesia + sacral ESP block.
Intraoperative opioid consumption and other parameters of the patients will be recorded.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
intraoperative remifentanil compsumtion
Time Frame: intraoperative period
|
intraoperative period
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- AEŞH-EK-2026-154
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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