- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07654556
Investigating the Analgesic Efficacy and Ease of Perfomance of Modified Throracoabdominal Plane Block and Comparing it With Erector Spinea Plane Block in Laparacopic Sleeve Gasterctomy Surgeries
Evaluating Analgesic Efficacy and Feasibility of Modified Thoracoabdominal Plane Block Compared With Erector Spinae Plane Block in Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Study
Interest in surgical weight loss interventions continues to rise in the face of what has been dubbed the obesity epidemic. The most popular of these weight loss interventions is laparoscopic sleeve gastrectomy, which has proven to reduce morbidity and mortality of morbidly obese patients. The aim of effective perioperative pain management extends beyond increased patient comfort and includes reduced recumbency period, enhanced recovery, reduced hospital stay, and lowers postoperative complication rates.
Effective postoperative pain management has traditionally relied on multimodal strategies that combine systemic opioids, non-opioid medications, and regional anesthesia. Despite their efficacy, opioids are associated with a range of undesirable effects, such as nausea, vomiting, sedation, pruritus, and respiratory depression, which may impede early mobilization and recovery. These concerns have accelerated the adoption of ultrasound-guided regional anesthesia techniques as part of Enhanced Recovery After Surgery (ERAS) protocols, delivering superior pain control with fewer systemic adverse effects.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Among the newer regional techniques described for thoracoabdominal analgesia are the Modified thoracoabdominal plane block through perichondrial approach (M-TAPA) block and the erector spinae plane (ESP) block. The visceral analgesic effect of ESPB appears inconsistent and may be limited by technical and anatomical factors. ESPB requires relatively deep needle placement at thoracic levels, and achieving reliable anterior spread of local anesthetic is highly operator dependent. These challenges may be exacerbated in obese patients undergoing bariatric surgery, in whom ultrasound visualization and needle control can be technically demanding. Furthermore, uncertainty regarding the mechanism and extent of visceral afferent blockade, along with concerns about potential complications related to deep paraspinal injection, may limit the reproducibility and routine clinical applicability of ESPB in this population.
In contrast, the modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) is a more superficial and anatomically predictable technique designed to block thoracoabdominal nerves supplying the upper abdominal wall. Emerging evidence suggests that M-TAPA provides effective postoperative analgesia and opioid-sparing benefits in upper abdominal laparoscopic surgery, with a simpler and potentially safer technical profile compared with deeper regional techniques. Given its reduced operator dependency and technical simplicity, M-TAPA may represent an appealing alternative for patients undergoing laparoscopic sleeve gastrectomy. However, direct comparative evidence between ESPB and M-TAPA in this specific surgical context, particularly with respect to visceral pain control, remains lacking. Therefore, a randomized comparison of these two techniques is warranted.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Hesham khedr Prof. Dr., Professor
- Numero di telefono: 02 01001622640
- Email: hkhishamkhedr@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Patients from both sexes.
- 18 to 60 years old.
- ASA physical status II-III scheduled for laparoscopic sleeve gastrectomy.
- Patients with BMI (40-50) kg/ m2
Exclusion Criteria:
- Patient Refusal
- Lack of patient cooperation.
- Patients with any contraindication to regional nerve blocks as coagulopathy or infection at site of injection
- Patients with anatomical abnormalities at site of injection
- Patients with known hypersensitivity to bupivacaine, or any of the used drugs.
- Patients with pre-existing neurological disorder
- Patients with chronic pain syndromes including fibromyalgia, complex regional pain syndrome (CRPS), or chronic pain requiring long-term opioid or neuropathic pain medications.
- Patients with history of long-acting opioids, steroids, anticonvulsants perioperatively.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Modified thoracoabdominal plane block through perichondrial approach (M-TAPA)
The M-TAPA block will be performed after induction of general anaethesia, with total volume of 25ml of 0.25% bupivacaine.
|
A bilateral injection of 25 ml of 0.25% bupivacaine will be injected as a part of ultrasound guided M-TAPA block.
|
|
Comparatore attivo: Erector Spinea plane block (ESP block)
The ESP block will be performed after induction of general anaethesia , with total volume of 40 ml of 0.25% bupivacaine.
|
A bilateral injection of 25 ml of 0.25% bupivacaine will be injected as a part of ultrasound guided ESP block.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Postoperative Visual Analogue Score
Lasso di tempo: 48 hours
|
Measurment of postoperative Visual Analogue Score, which is a scale from 0 to 10 in which 0 indicates no pain while 10 denotes unbearable pain, this will be done after 48 hours.
|
48 hours
|
Collaboratori e investigatori
Sponsor
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MD-79-2026
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 .
Prove cliniche su Dolore postoperatorio
-
Cairo UniversityCompletatoSCOPO PAIN (VAS) a 24 ore dopo l'interventoEgitto
-
University of OklahomaThe Children's Hospital at OU Medical CenterCompletatoDolore addominale funzionale | Crisi falciforme | Pazienti seguiti dal Pain Team
-
King Abdulaziz UniversityReclutamentoDisturbi temporomandibolari (TMD) | Dolore dell'ATM | Arteterapia | TMJ - orale & amp; chirurgia maxillofaciale | Wilkes 1 e 2 | TMD Art Pain StudyArabia Saudita
Prove cliniche su Bupivacaine 0.25% (isobaric)
-
Havva Betül BacakCompletatoGestione del dolore postoperatorioTurchia (Türkiye)
-
Ain Shams UniversityCompletatoDolore durante il posizionamento spinaleEgitto
-
Center for Vulvovaginal DisordersNational Vulvodynia AssociationReclutamentoVulvodinia | Vestibolodinia provocata | Vestibolodinia Secondaria Provocata | Disturbi del Dolore Vulvare | Vestibolodinia Neuroproliferativa | Neuroinfiammazione mediata dai Mastociti | Dispareunia da inserimentoStati Uniti
-
Soterix MedicalColumbia University Irving Medical Center, New York, NYNon ancora reclutamento
-
Pamukkale UniversityCompletatoDolore, Postoperatorio | Emorragia | Analgesia | Ferita curativaTacchino
-
Indonesia UniversityCompletatoOperazione al ginocchio | Chirurgia pelvica | Anestesia spinaleIndonesia
-
Biomedical Advanced Research and Development AuthorityRho Federal Systems Division, Inc.; ICON plcAttivo, non reclutante
-
Ain Shams UniversityCompletatoChirurgia artroscopica della spalla | Dolore postoperatorio, acutoEgitto
-
University Hospitals Cleveland Medical CenterReclutamento
-
Yasser S Mostafa, MDReclutamento