Ultrasound Guided Sacral Erector Spinae Plane Block in vNOTES Surgery

July 28, 2026 updated by: Seyyid Furkan Kına

Ltrasound Guided Sacral Erector Spinae Plane Block in vNOTES Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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 conventional 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. Effective perioperative analgesia is crucial for optimizing recovery after gynecological surgery and improving patient satisfaction. Opioids remain the primary method for intraoperative analgesia; however, their use is associated with well-known side effects such as postoperative nausea and vomiting, respiratory depression, and delayed recovery. Therefore, multimodal analgesic strategies incorporating regional anesthesia techniques to reduce perioperative opioid consumption are increasingly being investigated. Erector spinae plane (ESP) block is a relatively new fascial plane block, first described in 2016 and since then applied in a wide variety of thoracic and abdominal surgical procedures. By injecting a local anesthetic deeply beneath the erector spinae muscle, the block can extend along the fascial plane, potentially affecting both dorsal and ventral branches and providing somatic and possibly visceral analgesia. Recently, a sacral modification of the ESP block has been described as a promising technique for surgeries involving the 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 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 and lower postoperative pain scores. 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. Since sacral ESP block is routinely used in the operating room, this study poses no risk to patients or healthcare professionals. This study will include patients scheduled for vNOTES surgery at the Oncology Ward of Ankara Etlik City Hospital. Patients will be randomly assigned to two groups in the operating room during the preoperative period. Patients will be randomly assigned to two groups in a 1:1 ratio using a computer-generated random assignment sequence. Assignment confidentiality will be ensured using consecutively numbered, opaque, and sealed envelopes. The group undergoing the block will receive bilateral sacral ESP blocks at the S2-3 level 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 (stepped remifentanil titration protocol). Heart rate and mean arterial pressure values will be recorded during the colpotomy and uterine traction phases of the patients. 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. NRS scores will be recorded at 0, 2, 6, 12, and 24 hours postoperatively (0: no pain, 10: unbearable pain). Postoperative nausea, vomiting, and side effects will also be recorded. The time of discharge of patients will also be recorded. All patients will be given detailed information before the study, and those who volunteer will be included. Patients who do not wish to participate in the study will be excluded. Patients excluded from the study will not be deprived of any treatment. Routine treatment and analgesic administration will be continued.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / 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

Outcome Measure
Time Frame
intraoperative remifentanil compsumtion
Time Frame: intraoperative period
intraoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 25, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

August 25, 2026

Study Registration Dates

First Submitted

July 24, 2026

First Submitted That Met QC Criteria

July 24, 2026

First Posted (Actual)

July 28, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • AEŞH-EK-2026-154

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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