NCT Number: NCT07729488
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 opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
Fatma Acil, Diyarbakır, Outside of the US, Turkey (Türkiye)
Video-assisted thoracoscopic surgery (VATS) has become the preferred surgical approach for many thoracic procedures because of its minimally invasive nature. Nevertheless, patients frequently experience moderate to severe postoperative pain, which may impair respiratory function, delay mobilization, prolong hospitalization, and negatively affect overall recovery. Effective multimodal analgesia is therefore essential for optimizing postoperative outcomes.
Ultrasound-guided erector spinae plane block (ESPB) and serratus posterior superior intercostal plane block (SPSIPB) are interfascial plane blocks that have demonstrated promising analgesic efficacy in thoracic surgery. Although both techniques are increasingly used in clinical practice, evidence directly comparing their effects on postoperative quality of recovery following VATS is limited.
This prospective, randomized, double-blind, parallel-group clinical trial will enroll 128 adult patients (18-70 years, ASA physical status I-III) undergoing elective VATS. Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided ESPB or ultrasound-guided SPSIPB before surgery.
The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours after surgery. Secondary outcomes include postoperative pain scores at rest and during coughing, cumulative 24-hour tramadol consumption, time to first rescue analgesia, rescue analgesic requirement, postoperative nausea and vomiting, sedation level, patient satisfaction, length of hospital stay, block-related complications, perioperative hemodynamic variables, and additional analgesic requirements.
The results of this study are expected to provide high-quality evidence regarding the comparative effectiveness of ESPB and SPSIPB in improving postoperative recovery and analgesic outcomes after VATS and may contribute to optimizing regional analgesia strategies for thoracic surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Ultrasound-Guided Erector Spinae Plane Block
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.
Other names: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block
Time frame: 24 hours after surgery
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.
Time frame: 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.
Postoperative pain intensity at rest will be assessed using an 11-point Numerical Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.
Postoperative pain intensity during coughing will be assessed using an 11-point Numerical Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: During the first 24 hours after surgery
The time from arrival in the post-anesthesia care unit (PACU) to the first administration of rescue analgesia will be recorded in minutes.
Time frame: During the first 24 hours after surgery
The total amount of tramadol administered for postoperative rescue analgesia during the first 24 hours after surgery will be recorded in milligrams (mg).
Time frame: During the first 24 hours after surgery
The proportion of participants requiring at least one dose of rescue analgesia during the first 24 hours after surgery will be recorded.
Time frame: During the first 24 hours after surgery
Postoperative nausea and vomiting will be assessed using the Simplified Postoperative Nausea and Vomiting Impact Scale. The scale combines the number of vomiting episodes and the perceived impact of nausea on recovery, with a total score ranging from 0 to 6. Higher scores indicate a greater impact of postoperative nausea and vomiting, and a score of 5 or greater indicates clinically important PONV.
Time frame: 24 hours after surgery
Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, and 5 = very satisfied. Higher scores indicate greater patient satisfaction.
Time frame: From surgery until hospital discharge (up to 30 days)
Postoperative length of hospital stay will be recorded as the number of days from surgery until hospital discharge.
Time frame: From block performance until hospital discharge (up to 30 days)
The incidence of block-related complications, including local anesthetic systemic toxicity, pneumothorax, hematoma, infection, vascular puncture, and other procedure-related adverse events, will be recorded.
Contact information is provided by the study sponsor or research team.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Other
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block for Quality of Recovery After Video-Assisted Thoracoscopic Surgery: A Randomized Double-Blind Trial
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