NCT07729488

Brief Summary

Video-assisted thoracoscopic surgery (VATS) is associated with moderate to severe postoperative pain despite its minimally invasive nature. Ultrasound-guided erector spinae plane block (ESPB) and serratus posterior superior intercostal plane block (SPSIPB) are promising regional analgesic techniques for thoracic surgery; however, evidence directly comparing their effects on postoperative quality of recovery remains limited. This prospective, randomized, double-blind controlled trial aims to compare the effects of ESPB and SPSIPB on postoperative quality of recovery, measured by the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours after surgery. Secondary outcomes include postoperative pain scores, tramadol consumption, time to first rescue analgesia, rescue analgesic requirement, postoperative nausea and vomiting, patient satisfaction, length of hospital stay, block-related complications, and perioperative hemodynamic parameters.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

July 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 16, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

July 22, 2026

Last Update Submit

September 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery-15 (QoR-15) Score

    Postoperative quality of recovery will be assessed using the validated Turkish version of the Quality of Recovery-15 questionnaire. The total score ranges from 0 to 150, with higher scores indicating better recovery. The preoperative QoR-15 score will be recorded as a baseline measurement and considered in the analysis of the postoperative 24-hour score.

    24 hours after surgery

Secondary Outcomes (9)

  • Postoperative Pain at Rest

    30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.

  • Postoperative Pain Intensity During Coughing

    30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.

  • Time to First Rescue Analgesia

    During the first 24 hours after surgery

  • Cumulative Postoperative Tramadol Consumption

    During the first 24 hours after surgery

  • Requirement for Rescue Analgesia

    During the first 24 hours after surgery

  • +4 more secondary outcomes

Study Arms (2)

Ultrasound-Guided Erector Spinae Plane Block (ESPB)

EXPERIMENTAL

An ultrasound-guided erector spinae plane block (ESPB) will be performed before induction of general anesthesia using 30 mL of 0.25% bupivacaine for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery (VATS).

Procedure: ESPB

Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

EXPERIMENTAL

An ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) will be performed before induction of general anesthesia using 30 mL of 0.25% bupivacaine for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery (VATS).

Procedure: SPSIPB

Interventions

ESPBPROCEDURE

An ultrasound-guided erector spinae plane block will be performed preoperatively for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery. The block will be performed using the standardized study protocol.

Also known as: Ultrasound-Guided Erector Spinae Plane Block
Ultrasound-Guided Erector Spinae Plane Block (ESPB)
SPSIPBPROCEDURE

An ultrasound-guided serratus posterior superior intercostal plane block will be performed preoperatively for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery. The block will be performed using the standardized study protocol.

Also known as: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-85 years.
  • ASA physical status I-III.
  • Scheduled for elective VATS under general anesthesia.
  • Able to understand and complete the QoR-15 questionnaire.
  • Written informed consent provided.

You may not qualify if:

  • Refusal to participate or inability to provide written informed consent.
  • Known allergy or contraindication to bupivacaine, paracetamol, dexketoprofen, or tramadol.
  • Infection at the planned block injection site.
  • Coagulopathy or ongoing anticoagulant therapy precluding regional anesthesia.
  • Severe hepatic or renal insufficiency.
  • Chronic opioid use or chronic pain requiring regular analgesic treatment.
  • Previous thoracic surgery on the operative side.
  • Pregnancy or breastfeeding.
  • Cognitive impairment, psychiatric illness, or language barrier preventing completion of the QoR-15 questionnaire.
  • Body mass index (BMI) \>35 kg/m².
  • Conversion from VATS to thoracotomy.
  • Failed or incomplete regional block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fatma Acil

Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)

RECRUITING

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, Turkey, 21070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Fatma Acil, M.D.

    Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Acil, M.D.

CONTACT

Andaç Dedeoğlu, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and postoperative outcome assessors will be blinded to treatment allocation. Ultrasound-guided blocks will be performed by an experienced anesthesiologist who will not participate in postoperative assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants undergoing elective video-assisted thoracoscopic surgery (VATS) will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided erector spinae plane block (ESPB) or ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB). Outcomes will be compared between the two parallel groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 27, 2026

Study Start

September 16, 2026

Primary Completion (Estimated)

December 29, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 21, 2026

Record last verified: 2026-09

Locations