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- Sperimentazione clinica NCT07564180
Spinal Anesthesia With Bupivacaine Versus Prilocaine on Postoperative Shivering After Inguinal Hernia Repair
Effect of Spinal Anesthesia With Bupivacaine Versus Prilocaine on Postoperative Shivering After Inguinal Hernia Repair : a Prospective Randomized Double Blind Study
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Inguinal hernia is the most common type of abdominal hernia, more common in men than women. Inguinal hernia repair is performed under general, spinal anesthesia or local anesthesia.
Core body temperature is normally tightly regulated to within a few tenths of a degree. The major thermoregulatory defenses in humans are sweating, arteriovenous shunt vasoconstriction, and shivering.
Spinal anesthesia is considered a safe anesthetic technique for the surgery, however 40 to 60 percent of patients' experience shivering due to vasodilatation, which facilitates rapid heat loss and causes a redistribution of body heat from the core to peripheral tissue. However, perioperative heat loss due to exposure of skin, evaporation from exposed sites, cold intravenous fluids, contribute to factors that predispose shivering. Postoperative shivering can be either thermos-genic with hypothermia or nonthermogenic associated with pain modulation and surgical stress.
Shivering is considered undesirable, as these random spontaneous, asynchronous skeletal muscle contractions increases the basal metabolism with increase in oxygen consumption up to be 600% hypoxemia, metabolic acidosis, triggering myocardial ischemia, increased wound pain, delayed wound healing, as well as increase in blood pressure, intraocular and intracranial pressure.
Bupivacaine is a long acting local anesthetic belonging to the amide group it is more stable and less likely to cause allergic reactions among other local anesthetics however; it delays hospital discharge in ambulatory surgery. Prilocaine is a local anesthetic belonging to the amide group with rapid onset, intermediate potency, and action.
The old local anesthetics prilocaine was reintroduced in the market as hyperbaric prilocaine 2% which provides anesthesia for 75-90 minutes after spinal administration, thus increasingly used in the ambulatory setting.
Since bupivacaine 0.5% has significantly prolonged postoperative analgesic duration versus prilocaine 2%, thus We hypothesis that bupivacaine may have a superior effect on minimizing postoperative shivering through providing better analgesia.
The main aim of this study is to compare spinal anesthesia with prilocaine 2%, versus bupivacaine 0.5% on postoperative shivering during repair of inguinal hernia.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: amr mohamed, doctorate degree
- Numero di telefono: 020 1140202083
- Email: amr.mohamed.a1@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- patients with inguinal hernia under spinal anesthesia aged from 20 to 60 years
Exclusion Criteria:
Patients suffering from neurological diseases, uncompensated cardiac or respiratory problems, active lumber disc herniation, and history of addiction to other substances as well as those under treatment affecting results will be excluded from the study. Also, patients with a history of previous back surgery, infection at the injection site, hypersensitivity to amide local anesthetics, mental disturbance, congenital or acquired methemoglobinemia, coagulation disorders will also be excluded from the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Prilocaine group
Prilocaine intrathecal injection ( spinal anesthesia )
|
Group P; (n=40) will receive prilocaine2% (Takipril, Sunny Medical, Egypt).
Altri nomi:
In both groups the patients will be in the sitting position after preparation and draping of the patient's back. A skin wheal will be made by 1 ml of lidocaine HCl 2% at L3-4 interspace using a 25-gauge needle. Hyperbaric bupivacaine 0.5% will be given in dose (15mg) in group B and hyperbaric prilocaine2% in dose (60mg) in Group P. Anesthesia will be prepared by personnel not involved in this study. Patients will be supplemented with oxygen 5.0 l/minute by face mask. Time to achieve T10 dermatome will be recorded also motor level by modified Bromage motor blockade score; 4=no motor block, 3=can flex leg at knee, 2=can flex leg at the ankle and 1= complete motor block. The time needed to reach the maximum block will be recorded. In both groups the hemodynamic parameters will be recorded before block, immediately after block then every 5 min till end of the operation. Need for sedation or analgesia will be recorded.
Altri nomi:
|
|
Comparatore attivo: Buivacaine group
Bupivacaine intrathecal injection ( spinal anesthesia )
|
In both groups the patients will be in the sitting position after preparation and draping of the patient's back. A skin wheal will be made by 1 ml of lidocaine HCl 2% at L3-4 interspace using a 25-gauge needle. Hyperbaric bupivacaine 0.5% will be given in dose (15mg) in group B and hyperbaric prilocaine2% in dose (60mg) in Group P. Anesthesia will be prepared by personnel not involved in this study. Patients will be supplemented with oxygen 5.0 l/minute by face mask. Time to achieve T10 dermatome will be recorded also motor level by modified Bromage motor blockade score; 4=no motor block, 3=can flex leg at knee, 2=can flex leg at the ankle and 1= complete motor block. The time needed to reach the maximum block will be recorded. In both groups the hemodynamic parameters will be recorded before block, immediately after block then every 5 min till end of the operation. Need for sedation or analgesia will be recorded.
Altri nomi:
Group B: (n=40) patients receiving hyperbaric bupivacaine 0.5% (Marcaine, Sunny Medical, Egypt).
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
shivering using bedside shivering assesement score ( BSAS)
Lasso di tempo: one year
|
one year
|
|
|
shivering using bedside shivering assesement score ( BSAS)
Lasso di tempo: 1 year
|
shivering using bedside shivering assesement score ( BSAS)
|
1 year
|
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Condizioni patologiche, anatomiche
- Condizioni patologiche, segni e sintomi
- Ernia
- Prodotti chimici organici
- Terapie
- Rotte della somministrazione di droga
- Terapia farmacologica
- Anilides
- Amides
- Composti di anilina
- Ammine
- Anestesia e analgesia
- Anestesia, conduzione
- Anestesia
- Iniezioni
- Bupivacaina
- Prilocaina
- Anestesia, spinale
- Iniezioni, Spinale
Altri numeri di identificazione dello studio
- Theodore Bilharz
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- CODICE_ANALITICO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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prodotto fabbricato ed esportato dagli 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 .
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