- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07930078
Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block Under Skin Conductance Algesimeter Guidance in Laparoscopic Gynecologic Oncologic Surgery
Comparison of the Analgesic Efficacy of Bilateral Subcostal Transversus Abdominis Plane Block and Bilateral Erector Spinae Plane Block Guided by Skin Conductance Algesimeter Pain Monitoring in Laparoscopic Gynecologic Oncologic Surgery: A Prospective Randomized Study
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Savaş Altınsoy
- Numero di telefono: 05332257104
- Email: savasaltinsoy@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Women aged 18-65 years Scheduled for elective laparoscopic gynecologic oncologic surgery ASA physical status I-III Body mass index 18-40 kg/m² Written informed consent No contraindication to regional block
Exclusion Criteria:
Age <18 or >65 years ASA physical status IV or higher Severe systemic comorbidity Known allergy to local anesthetics Bleeding diathesis or coagulopathy Infection at the block site Body mass index <18 or >40 kg/m² Emergency surgery
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: 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. |
Procedure: Erector spinae plane block - Ultrasound-guided bilateral ESP block at T9 with 20 mL of 0.25% bupivacaine per side. Arm: ESP Group. |
|
Altro: 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. |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Total intraoperative remifentanil consumption
Lasso di tempo: from induction of anesthesia to the end of surgery.
|
Total intraoperative remifentanil consumption - Total amount of remifentanil (µg) administered under skin conductance algesimeter guidance. |
from induction of anesthesia to the end of surgery.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to first rescue analgesic
Lasso di tempo: 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
Time to first rescue analgesic - Time from extubation to the first rescue analgesic administration (minutes). Time frame: first 24 postoperative hours. |
0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
|
Rescue analgesic requirement
Lasso di tempo: 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
Rescue analgesic requirement - Number of patients receiving rescue analgesics (tenoxicam or tramadol). 0, 2, 4, 6, 12, 18, and 24 hours postoperatively. |
0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
|
Postoperative pain scores
Lasso di tempo: 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
Postoperative pain scores - Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain). |
0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
|
Quality of recovery
Lasso di tempo: Time frame: preoperatively and 24 hours postoperatively.
|
Quality of recovery - Quality of Recovery-15 (QoR-15) score (0-150; higher scores indicate better recovery). |
Time frame: preoperatively and 24 hours postoperatively.
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Savaş Altınsoy, Ankara Etlik City Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Dolore
- Manifestazioni neurologiche
- Complicanze postoperatorie
- Processi patologici
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie genitali, femmina
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Dolore, Postoperatorio
- Neoplasie genitali, femmina
Altri numeri di identificazione dello studio
- Furkan Hökelekli Tez
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .