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Sacral Erector Spinae Plane BlockNCT07732322

Ultrasound Guided Sacral Erector Spinae Plane Block in vNOTES Surgery

A study testing Sacral ESP block in people with Sacral Erector Spinae Plane Block, run by Seyyid Furkan Kına at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Sacral Erector Spinae Plane Block
What is being tested?
Sacral ESP block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Jul 2026to 25 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Etlik City Hospital

    Altındağ, Ankara, 06000

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Sacral ESP block
Keywords
vNOTES, Sacral erector spinae plane block, Peripheral nerve block, Gynecological oncological surgery, Anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacral ESP blockProcedure or surgery

    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.

Study groups in NCT07732322
Study groupRoleWhat they receive
General anesthesiaActive comparatorIntraoperative 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.
Receives: Procedure: Sacral ESP block
General anesthesia + Sacral ESP blockActive comparatorBilateral 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
Receives: Procedure: Sacral ESP block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. intraoperative remifentanil compsumtion

    Measured: intraoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start25 Jul 2026
  3. Primary completion10 Aug 2026
  4. Study completion25 Aug 2026

Resources

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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07732322
Sponsor's protocol ID
AEŞH-EK-2026-154
Status last verified
Sep 2026
First submitted
24 Jul 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sacral ESP block in people with Sacral Erector Spinae Plane Block, run by Seyyid Furkan Kına 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 10 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intraoperative remifentanil compsumtion (time frame: intraoperative 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 10 Sep 2026.

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