Ultrasound Guided Sacral Erector Spinae Plane Block in vNOTES Surgery

NCT07732322 | Not Yet Recruiting

• 1 other identifier: AEŞH-EK-2026-154
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Vaginal natural opening transendoscopic surgery (vNOTES) has emerged as a minimally invasive surgical approach in gynecological procedures. By utilizing the vaginal passage as a natural opening, vNOTES eliminates abdominal incisions and has been associated with less postoperative pain, shorter hospital stays, and faster recovery compared to traditional laparoscopic surgery. Despite these advantages, patients undergoing vNOTES may still experience significant perioperative pain due to visceral pelvic manipulation, colpotomy, and uterine traction during the procedure. Recently, sacral modification of ESP block has been described as a promising technique for surgeries involving sacral and perineal regions. Ultrasound-guided sacral ESP block has demonstrated beneficial postoperative analgesic effects in procedures such as pilonidal sinus surgery and other perineal operations. However, the potential role of sacral ESP block in gynecological procedures, particularly in vNOTES surgery, has not yet been sufficiently explored. Pelvic organs receive complex autonomic and somatic innervation, primarily originating from the sacral segments (S2-S4), including the pelvic splanchnic nerves and the pudendal nerve. Targeting these nerve pathways with sacral ESP block can provide effective analgesia for both the visceral and somatic components of pain associated with vNOTES procedures. Therefore, this prospective randomized study aimed to evaluate the effect of ultrasound-guided sacral erector spinae plane block on intraoperative opioid consumption in patients undergoing vNOTES surgery. It was hypothesized that adding sacral ESP block to general anesthesia would reduce intraoperative remifentanil requirements, lower postoperative pain scores, and decrease the amount of analgesics consumed postoperatively. The primary objective of this study was to investigate the effects of sacral ESP block on intraoperative opioid consumption in challenging vNOTES; the secondary objective was to determine its effects on postoperative pain scores and the amount of analgesics consumed.

Conditions

Sacral Erector Spinae Plane Block

Keywords

vNOTES; Sacral erector spinae plane block; Peripheral nerve block; Gynecological oncological surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• intraoperative remifentanil compsumtion

  intraoperative period

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

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.

Procedure: Sacral ESP block

General anesthesia + Sacral ESP block

ACTIVE COMPARATOR

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

Procedure: Sacral ESP block

Interventions

Sacral ESP block PROCEDURE

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.

General anesthesia; General anesthesia + Sacral ESP block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: women undergoing elective vNOTES surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65
• Planned for elective vNOTES surgery
• ASA 1-3
• BMI \<35

You may not qualify if:

• 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

Sponsors & Collaborators

• Seyyid Furkan Kına: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 28, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07