Bier's Block Versus Systemic Analgesia
Ključne riječi
Sažetak
Opis
Patients and Methods
Study Design
This is a randomized clinical trial to be conducted at two tertiary health care centers, with census of 102000 and 60000 visits per year, during years 2017 and 2018. The study design has been approved by ethics committee of the university. Informed consents will be obtained from patients. And patients who refuse to participate in the study are excluded from the study and will receive analgesia based on the physician responsible for analgesia preference.
Population
All adult patients (aged 18 or more) with upper extremity trauma who need procedural analgesia in the ED are included in this study. Patients with a history of seizure, known allergy to analgesic substances, sickle cell anemia, peripheral vascular disease and arteriovenous fistula or infection in upper extremities are excluded from the study. Patients who need emergent intervention/s that last more than one hour are also excluded from the study. Randomization is done using sealed envelopes containing computer-generated block random allocation numbers.
Intervention
After introduction of the protocol of Bier's block (using 1.5 mg/kg of 0.5% lidocaine) or systemic analgesia (using ketamine 1.5 mg/kg), patients underwent the necessary procedure. Physicians who were responsible for the analgesia, had authority to change the method of analgesia in each group, if necessary.
Measurements
Patient's age, sex, site and type of injury, vital signs and pain score using the Numerical Rating Scale (NRS) will be recorded before the introduction of analgesia. Patient's vital signs are documented at the end of the procedure. Satisfaction of the patient, surgeon and physician responsible for analgesia for the applied analgesic method is obtained before discharge from the ED operating room. Patients also score their level of pain before discharge and their vital signs are recorded at another instance. Time of initiation of analgesia, initiation of procedure, end of procedure, and gaining consciousness in systemic analgesia group and time of discharge from ED operating room are documented and patients will be discharged from the ED operating room when eligible.
Datumi
| Posljednja provjera: | 10/31/2017 |
| Prvo podneseno: | 11/10/2017 |
| Predviđena prijava predata: | 11/15/2017 |
| Prvo objavljeno: | 11/20/2017 |
| Zadnje ažuriranje poslato: | 11/15/2017 |
| Posljednje ažuriranje objavljeno: | 11/20/2017 |
| Stvarni datum početka studija: | 10/19/2017 |
| Procijenjeni datum primarnog završetka: | 12/31/2017 |
| Predviđeni datum završetka studije: | 03/31/2018 |
Stanje ili bolest
Intervencija / liječenje
Procedure: Intravenous regional Analgesia
Drug: Systemic Analgesia
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| Experimental: Intravenous regional Analgesia in this arm patients will receive intravenous regional anesthesia as infusion of mini dose (that is 1.5 mg/kg ) lidocaine 0.5% and immediately after procedure their torniquettes will be deflated (hence named Rapid MiniBier's block). | Procedure: Intravenous regional Analgesia in this research patients will receive intravenous regional anesthesia as infusion of mini dose (that is 1.5 mg/kg ) lidocaine 0.5% and immediately after procedure their torniquettes (A.T.S. 2000, Zimmer, Inc., Bloomfield, CN) will be deflated (hence named Rapid MiniBier's block). the pain score will be assessed by NRS system before during and after the procedure. |
| Experimental: Systemic Analgesia In this arm patients will receive ketamine 1-2 mg/kg IV slow as a systemic analgesia. ketamine as a PCP derivative has both hypnotic and analgesic effects. | Drug: Systemic Analgesia in this group the patients will receive ketamine 1-2 mg/kg IV slow ( Bioniche,Ireland Ketamine Hydrochloride 500mg/10cc)and titrated to effect. again here the pain score will be assessed before procedure and after the procedure every 5 minutes until 30 minutes by NRS ( Numerical Rating Score) |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 18 Years To 18 Years |
| Polovi podobni za studiranje | All |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | Inclusion Criteria: - All adult patients (aged 18 or more) with upper extremity trauma who need procedural analgesia Exclusion Criteria: - Patients with a history of seizure - Known allergy to analgesic substances - Sickle cell anemia, - Peripheral vascular disease and arteriovenous fistula - Infection in upper extremities - Patients who need emergent intervention/s that last more than one hour are also excluded from the study. |
Ishod
Primarne mjere ishoda
1. pain score [30 minutes since the beginning of procedure]
Sekundarne mjere ishoda
1. Complications [30 minutes]
