- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07661693
ESP vs Subcostal TAP Block for Analgesia After Laparoscopic Cholecystectomy (ESP TAP)
Comparison Of Ultrasound-guided Erector Spinae Plane Block And Subcostal Transversus Abdominis Plane Block For Postoperative Analgesia In Laparoscopic Cholecystectomy: A Prospective Randomized Double-blind Multicenter Trial
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Postoperative pain remains a significant clinical concern after laparoscopic cholecystectomy despite the minimally invasive nature of the procedure. Inadequate analgesia may delay recovery, increase opioid consumption, and negatively affect patient satisfaction. Regional anesthesia techniques are increasingly incorporated into multimodal analgesia protocols to improve postoperative outcomes and reduce opioid requirements.
The erector spinae plane (ESP) block and the subcostal transversus abdominis plane (TAP) block are ultrasound-guided fascial plane blocks commonly used for abdominal surgery. While both techniques have demonstrated analgesic benefits, their comparative effectiveness in laparoscopic cholecystectomy remains uncertain. In particular, differences in visceral pain control, opioid-sparing effect, and shoulder pain incidence require further investigation.
This study is designed as a prospective, randomized, double-blind, parallel-group, clinical trial conducted at two tertiary care hospitals in Turkey. Eligible adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned to receive either bilateral ESP block or bilateral subcostal TAP block after induction of anesthesia. Standardized anesthesia and postoperative multimodal analgesia protocols will be applied in both groups to ensure comparability between centers.
The primary outcome measure is total opioid consumption within the first 24 postoperative hours, expressed as morphine equivalent dose. Secondary outcome measures include postoperative pain scores assessed using the Numerical Rating Scale (NRS), time to first analgesic request, incidence of shoulder pain, postoperative nausea and vomiting, and block-related complications.
Randomization will be performed using a computer-generated sequence, with allocation concealment ensured. Patients and postoperative outcome assessors will be blinded to group assignment. Data will be prospectively recorded and analyzed according to a predefined statistical analysis plan.
The findings of this study are expected to provide evidence-based guidance for optimizing regional analgesia strategies in laparoscopic cholecystectomy.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Bekir Suat Kürkçüoğlu
- Numero di telefono: 05055830463
- Email: bekirsuat@gmail.com
Backup dei contatti dello studio
- Nome: Bekir Suat Kürkçüoğlu
- Numero di telefono: +905055830463
- Email: bekirsuat@gmail.com
Luoghi di studio
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Gaziantep
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Şahinbey, Gaziantep, Turchia (Türkiye), 27060
- Gaziantep City Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
Adults aged 18 years and older
Scheduled for elective laparoscopic cholecystectomy under general anesthesia
American Society of Anesthesiologists (ASA) physical status I-III
Ability to understand the study protocol and provide written informed consent -
Exclusion Criteria:Refusal to participate
Known allergy or contraindication to local anesthetic agents
Coagulopathy or anticoagulant therapy contraindicating regional anesthesia
Infection at the planned injection site
Body mass index (BMI) > 35 kg/m²
Chronic opioid use or opioid dependence
Chronic pain syndromes requiring regular analgesic treatment
Severe hepatic, renal, or cardiac dysfunction
Pregnancy or breastfeeding
Inability to communicate or assess pain using the Numerical Rating Scale (NRS)
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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Erector Spinae Plane Block
Patients in this arm will receive ultrasound-guided bilateral erector spinae plane block following induction of general anesthesia.
A standardized volume and concentration of local anesthetic will be administered at the appropriate thoracic level.
All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia.
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Ultrasound-guided bilateral erector spinae plane block will be performed after induction of general anesthesia.
The block will be administered at the appropriate thoracic vertebral level using a standardized volume and concentration of local anesthetic deposited in the fascial plane deep to the erector spinae muscle.
The procedure will be performed by experienced anesthesiologists under sterile conditions.
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Sperimentale: Subcostal TAP Block
Patients in this arm will receive ultrasound-guided bilateral subcostal transversus abdominis plane block following induction of general anesthesia.
A standardized volume and concentration of local anesthetic will be administered.
All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia.
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Ultrasound-guided bilateral subcostal transversus abdominis plane block will be performed after induction of general anesthesia.
A standardized volume and concentration of local anesthetic will be injected into the fascial plane between the rectus abdominis and transversus abdominis muscles along the subcostal margin.
The procedure will be performed by experienced anesthesiologists under sterile conditions.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total Opioid Consumption in the First 24 Hours Postoperatively
Lasso di tempo: Within 24 hours after surgery
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Total opioid consumption during the first 24 postoperative hours, converted to intravenous morphine equivalent dose (mg), recorded from patient-controlled analgesia devices and supplemental opioid administration.
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Within 24 hours after surgery
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Bekir Suat Kürkçüoğlu, Gaziantep City Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- This study will generate individual participant data (IPD) related to postoperative analgesia, including opioid consumption, pain scores, and block-related complications. Data will be de-identified prior to sharing. Access to IPD will be available upon reasonable request to the corresponding author after publication of the main study results. Data requests will require a signed data use agreement, specifying the purpose of analysis and acknowledgment of original investigators. Supporting documentation, including study protocol and statistical analysis plan, will also be provided to researchers granted access.
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
Altri numeri di identificazione dello studio
- BS-ESP-TAP-2026
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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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 .
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