ClinicalTrials.gg
Not yet recruitingNCT07930078Updated Nov 10, 2026

Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block Under Skin Conductance Algesimeter Guidance in Laparoscopic Gynecologic Oncologic Surgery

An interventional study of Erector spinae plane block and Subcostal transversus abdominis plane block in Postoperative Pain and Gynecologic Neoplasms, sponsored by Diskapi Yildirim Beyazit Education and Research Hospital. Not yet recruiting. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Diskapi Yildirim Beyazit Education and Research Hospital · Not applicable, Interventional, and Other

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

This prospective randomized study compared two ultrasound-guided regional anesthesia techniques used as part of multimodal analgesia in women undergoing elective laparoscopic gynecologic oncologic surgery: bilateral erector spinae plane (ESP) block and bilateral subcostal transversus abdominis plane (TAP) block. During general anesthesia, the remifentanil infusion was titrated according to the skin conductance algesimeter (SCA), a device that monitors the sympathetic response to noxious stimuli. The main question was whether ESP block reduces intraoperative remifentanil consumption compared with subcostal TAP block. Postoperative pain scores, rescue analgesic requirement, and quality of recovery were also compared during the first 24 postoperative hours.

Read the detailed description

Female patients aged 18-65 years with ASA physical status I-III scheduled for elective laparoscopic gynecologic oncologic surgery were randomized in a 1:1 ratio using a computer-generated list (Research Randomizer) to the ESP group or the subcostal TAP group. General anesthesia was induced with fentanyl 0.5 µg/kg, propofol 2.5 mg/kg, and rocuronium 0.6 mg/kg and maintained with sevoflurane at approximately 1 minimum alveolar concentration. After induction and before surgical incision, blocks were performed under ultrasound guidance by experienced anesthesiologists with 20 mL of 0.25% bupivacaine on each side (total 40 mL): bilateral ESP block at the T9 level in the lateral decubitus position, or bilateral subcostal TAP block at the midclavicular line below the costal margin in the supine position.

Remifentanil infusion was started at 0.05-0.2 µg/kg/min and titrated according to the SCA index: decreased by 0.025 µg/kg/min when the index was 0-1, maintained when it was 3, and increased by 0.025-0.05 µg/kg/min when it was above 3, with at least 5 minutes between dose changes. The infusion could be reduced to zero when the SCA index remained at 0-1. Heart rate, blood pressure, SCA index, and bispectral index (BIS) were recorded at baseline, after intubation, every 15 minutes during surgery, and before and after extubation. All patients received intravenous dexketoprofen 50 mg and paracetamol 1 g approximately 30 minutes before the end of surgery.

Postoperative pain was assessed with the Numeric Rating Scale (NRS) at 0, 2, 4, 6, 12, 18, and 24 hours. Tenoxicam was given for NRS ≥4 and tramadol for NRS ≥7 as rescue analgesics. The Quality of Recovery-15 (QoR-15) questionnaire was administered preoperatively and at 24 hours postoperatively. Intraoperative data and postoperative follow-up were recorded by investigators who did not perform the blocks.

02

Conditions studied

  • Postoperative Pain
  • Gynecologic Neoplasms

Keywords

  • Pain Measurement
  • Erector Spinae Plane Block
  • Transversus Abdominis Plane Block
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 66 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital is the lead sponsor of 71 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Women aged 18-65 years Scheduled for elective laparoscopic gynecologic oncologic surgery I-III 18-40 kg/m² Written No to regional block

Exclusion criteria

Exclusion Criteria:

Age \<18 or >65 years IV or higher Severe systemic comorbidity Known allergy to local anesthetics Bleeding diathesis or coagulopathy Infection at the block site \<18 or >40 kg/m² Emergency surgery

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
66 participants (estimated)

Study arms

  • Other
    ESP Group

    Bilateral ultrasound-guided erector spinae plane block at the T9 level with 20 mL of 0.25% bupivacaine on each side, performed after induction of general anesthesia and before surgical incision. Intraoperative remifentanil infusion titrated according to the skin conductance algesimeter index.

    Other: Erector spinae plane block

  • Other
    Subcostal TAP Group

    Bilateral ultrasound-guided subcostal transversus abdominis plane block with 20 mL of 0.25% bupivacaine on each side, performed after induction of general anesthesia and before surgical incision. Intraoperative remifentanil infusion titrated according to the skin conductance algesimeter index.

    Other: Subcostal transversus abdominis plane block

Interventions

  • OtherErector spinae plane block

    Procedure: Erector spinae plane block - Ultrasound-guided bilateral ESP block at T9 with 20 mL of 0.25% bupivacaine per side. Arm: ESP Group.

  • OtherSubcostal transversus abdominis plane block

    Procedure: Subcostal transversus abdominis plane block - Ultrasound-guided bilateral subcostal TAP block at the midclavicular line with 20 mL of 0.25% bupivacaine per side. Arm: Subcostal TAP Group.

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What researchers measure

Primary outcomes

  1. Total intraoperative remifentanil consumption

    Total intraoperative remifentanil consumption - Total amount of remifentanil (µg) administered under skin conductance algesimeter guidance.

    Time frame: from induction of anesthesia to the end of surgery.

Secondary outcomes

  1. Time to first rescue analgesic

    Time to first rescue analgesic - Time from extubation to the first rescue analgesic administration (minutes). Time frame: first 24 postoperative hours.

    Time frame: 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.

  2. Rescue analgesic requirement

    Rescue analgesic requirement - Number of patients receiving rescue analgesics (tenoxicam or tramadol). 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.

    Time frame: 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.

  3. Postoperative pain scores

    Postoperative pain scores - Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain).

    Time frame: 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.

  4. Quality of recovery

    Quality of recovery - Quality of Recovery-15 (QoR-15) score (0-150; higher scores indicate better recovery).

    Time frame: Time frame: preoperatively and 24 hours postoperatively.

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31. PubMed 29226150 ↗
  • Oraee S, Rajai Firouzabadi S, Mohammadi I, Alinejadfard M, Golsorkh H, Hatami S. Erector spinae plane block for laparoscopic surgeries: a systematic review and meta-analysis. BMC Anesthesiol. 2024 Oct 29;24(1):389. doi: 10.1186/s12871-024-02775-4. PubMed 39472781 ↗
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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.

Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 3 months is below that.

Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2026
First posted
Nov 10, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Feb 15, 2027
CompletionEst.
Mar 15, 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07930078
Lead sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Responsible party
Savas Altinsoy (Principal Investigator, Diskapi Yildirim Beyazit Education and Research Hospital) — Principal investigator
First posted
Nov 10, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Feb 15, 2027 (estimated)
Completion
Mar 15, 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

Savaş Altınsoy
Contact
savasaltinsoy@gmail.com
05332257104
Savaş Altınsoy
principal investigator · Ankara Etlik City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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