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Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Pericapsular Nerve Group Block( PENG)
The Analgesic Efficacy of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Pericapsular Nerve Group Block( PENG) in Patients Undergoing Laparoscopic Shoulder Surgeries: A Randomized Controlled Trial
Patients are greatly concerned about pain that occurs shortly after shoulder surgeries. Most patients experience significant pain after shoulder surgery, with almost half reporting severe pain immediately after. Since shoulder surgeries are usually done as outpatient or one day procedures, good pain control after surgery is important for quick recovery and rehab for patient's overall recovery. Interscalene nerve blocks provide the best pain relief for shoulder surgery patients. They reduce pain for at least 8 hours and decrease the need for opioids for 8 to 12 hours after surgery. It anesthetizes most of the brachial plexus, except the ulnar nerve (C8-T1). It is useful for surgeries on the distal clavicle, shoulder, and proximal humorous .However, interscalene blocks also raise concerns about temporary and potential long-term problems with breathing, especially paralysis of the diaphragm and phrenic nerve. By targeting nerve roots in the neck rather than peripheral nerves, interscalene blocks also carry a higher risk of nerve damage.The pericapsular nerve group block has been effectively used in hip surgeries as in hip arthroplasty and it is one of the best regional anesthesia regarding many other hip operations. Recently PENG block has also shown to have strong analgesic effect on shoulder surgeries.
Dexmedetomidine (DEX) is a highly selective Alpha-2 adrenergic agonist. It has sedative and analgesic properties that thought to be due to binding to both presynaptic and postsynaptic alpha-2 adrenoreceptors and inhibiting the release of norepinephrine, as a result, it terminates the propagation of pain signals and inhibits the sympathetic activity decreasing heart rate and blood pressure.
The aim of our study is to compare the effect of adding dexmedetomidine to bupivacaine in ultrasound-guided Pericapsular nerve group block (PENG) with bupivacaine alone and determine its effect on duration of analgesia and post-operative opioid consumption.
Visão geral do estudo
Descrição detalhada
Patients meeting the inclusion criteria will be randomly assigned to receive either:
Group A: PENG block with bupivacaine only (number of patients: 42) Group B: PENG block with bupivacaine and dexmedetomidine (number of patients: 42)
Preoperative assessment:
Preoperative assessment of all patients undergoing elective laparoscopic shoulder surgical procedures under general anaesthesia comprised of history taking, clinical examination, laboratory testing (complete blood count, kidney function tests, and liver function tests), electrocardiogram, and chest X-ray. The study protocol will be explained to the patients, and their consent will be obtained.
The visual analogue score (VAS) will be explained to all patient in details as it will be used as a measurement tool for assessment of postoperative pain
Operating Room preparation & Equipment:
The ultrasound used will be Siemens ACUSON X300 Ultrasound System, the scanning probe is a linear probe 8-14 MHZ. A 50-mm block needle 22 gauge will be used. (SonoPlex Stim Cannula, Germany).
All blocks will be given by one researcher using 20 ml of drug 0.25% bupivacaine either alone or with dexmedetomedine.
After arrival to the anesthetic room, an 18-gauge intravenous cannula will be placed at the forearm contralateral to the operated arm, standard monitoring will be used (non-invasive arterial blood pressure, ECG, pulse oximetry).
Premedication will be given intravenously in the form of 0.03 mg/kg midazolam, ranitidine 2.0 mg/kg IV and metoclopramide 0.1 mg/kg IV).
Patients will be randomly assigned to either the intervention group will receive PENG block with bupivacaine 0.25% and dexmedetomidine 1 µg/kg (maximum dose of 100 µg) diluted in normal saline (total volume of 20 mL) or control group will receive PENG block with bupivacaine 0.25% (20 mL) diluted in normal saline.
PENG block:
The patient will be asked to lie supine with his or her arm then positioned in a 45-degree abducted external rotation. A linear ultrasound probe was placed lengthwise between the coracoid and humeral head. Once the humeral head, subscapular muscle tendon, and deltoid muscle were identified, a 50-mm needle will be inserted using the "in plane" technique. The needle then will be advanced through the deltoid muscle and towards the subscapularis tendon, until a bony-like hard tissue is felt, preventing further advancement of the needle. The needle is placed now between the deltoid muscle and subscapularis tendon in which injection will be done.
Thirty minutes after performing the block patients will receive general anaesthesia. Anaesthesia will be induced with propofol (2 mg/kg), fentanyl (2 μg/kg) and atracurium (0.5 mg/kg). The GA will be maintained by isoflurane (1.2 %) and Atracurium (0.1 mg/kg/20 min). the surgery will then be started and intraoperative vital signs as heart rate, MAP (mean arterial blood pressure) will be monitored all throughout. If at anytime during the operation hypertension and tachycardia were observed, fentanyl 50 mic will be given as an intraoperative rescue analgesia.
After skin closure, muscle relaxation will be reversed using Neostigmine (0.04mg/kg) and Atropine (0.01mg/kg) after the return of spontaneous breathing. After extubation patients will be transferred to the post-anesthesia care unit (PACU) for 60 min for complete recovery and monitoring.
If at any point hypotension occurred (defined as a decrease in mean arterial pressure > 25% from the baseline value or systolic arterial pressure of 100 mmHg), it will be treated with 5 mg of IV bolus ephedrine, which will be repeated every 3 min until the hypotension resolved. Bradycardia (defined as an HR of 40 beats/min) will be treated with intravenous atropine (0.5 mg).
Postoperative vital signs (heart rate and MAP) and VAS for pain will be recorded at 0, 2, 6, 12, 24 hours and if VAS ≥3 or when the patient asks for analgesia, morphine IV (0.1mg/kg) will be given (rescue analgesia) targeting VAS ≤ 2 while the maximum allowed dose of morphine is 30 mg / 24 hours. The time to first call for analgesia is defined as (the time interval from tracheal extubation to first dose of morphine administration) will be recorded. The patient will receive paracetamol (1gm/8hrs IV) as a regular analgesia as soon as he is discharged from the recovery and admitted to the post-operative ward. The total amount of morphine in the first postoperative 24 hours will be calculated in both groups If the patient requires more than two doses of rescue analgesia in the first hour following surgery, the block will be deemed to have failed.
-Post operative haemodynamic will be assessed (heart rate and MAP at the same time point).
Incidence of adverse effects, such as hypotension, bradycardia, and sedation.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ahmed nabih, lecturer
- Número de telefone: +201002773488
- E-mail: nabihomar100@yahoo.com
Estude backup de contato
- Nome: Mohammed Belita, lecturer
- Número de telefone: +201001007485
- E-mail: mbeleta75@gmail.com
Locais de estudo
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Cairo, Egito
- Recrutamento
- Kasr AlAiny
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Contato:
- Ahmed nabih, lecturer
- Número de telefone: +201002773488
- E-mail: nabihomar100@yahoo.com
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Male or female patients aged 18-65 years
- Patients Undergoing laparoscopic shoulder surgeries (shoulder arthroplasties and shoulder endoscopic surgeries )
- American Society of Anesthesiologists (ASA) physical status I-II
Exclusion Criteria:
- Patient refusal.
- hypersensitivity or contraindication to dexmedetomidine
- History of allergy or intolerance to study medications
- Chronic opioid use (>3 months)
- Pregnancy or breastfeeding
- Severe renal or hepatic impairment
- Patient's with coagulopathy disorders
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: PENG block with bupivacaine
ultrasound-guided Pericapsular nerve group block with bupivacaine
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ultrasound-guided Pericapsular nerve group block
|
|
Experimental: PENG block with bupivacaine and dexmedetomidine
ultrasound-guided Pericapsular nerve group block with bupivacaine and dexmedetomidine
|
ultrasound-guided Pericapsular nerve group block
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hora de primeiro resgatar analgesia
Prazo: as primeiras 24 horas no pós -operatório
|
É definido como tempo desde a extubação até o tempo até o primeiro requisito analgésico durante as primeiras 24 horas no pós -operatório.
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as primeiras 24 horas no pós -operatório
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
O consumo total de opióides
Prazo: as primeiras 24 horas no pós -operatório
|
O consumo total de opióides em MG
|
as primeiras 24 horas no pós -operatório
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Nasr Abdallah, Professor, anesthesia department , cairo university
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Doenças musculoesqueléticas
- Doenças articulares
- Artralgia
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor no ombro
- Procedimentos cirúrgicos, operatórios
- Anestesia e analgesia
- Procedimentos neurocirúrgicos
- Anestesia, condução
- Anestesia
- Desnervação
- Bloqueio Nervoso
Outros números de identificação do estudo
- MS -493-2023
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