The Effect of Intravenous Dexketoprofen on the Severity and Incidence of Rebound Pain
Evaluation of the Effect of Intravenous Dexketoprofen on the Severity and Incidence of Rebound Pain in Patients Undergoing Interscalene Brachial Plexus Block
Orthopedic shoulder surgeries are associated with severe postoperative pain, particularly within the first 24-48 hours after surgery. In postoperative pain management, single or continue interscalene brachial plexus blocks, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids administered as needed are commonly used as components of multimodal analgesia.
Rebound pain is defined as severe postoperative pain (VAS ≥ 7) occurring within the first 24 hours after resolution of the block. It is considered an adverse effect of regional anesthesia and typically develops 8-12 hours after a single-shot nerve block. Risk factors for rebound pain include pre-existing pain, female sex, younger age, bone surgery, lack of intraoperative dexamethasone administration, and inadequate analgesia.
The primary objective of this study is to evaluate the effect of intravenous dexketoprofen administered during the postoperative period on the incidence and severity of rebound pain in patients undergoing shoulder surgery with interscalene brachial plexus block
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Sixty-six patients undergoing rotator cuff repair will receive standardized ISB and general anesthesia for the surgery.All patients will be administered 0.03 mg/kg of midazolam during the preoperative period and an interscalene brachial plexus block will be administered using 10 cc of %0.5 bupivacaine and 5 ml of normal saline.During induction under general anesthesia, the following will be administered: lidocaine 1 mg/kg, propofol 2-3 mg/kg, rocuronium 0.6 mg/kg, and remifentanyl 0.5 mcg/kg. Maintenance of anesthesia will be provided using a mixture of %2-3 sevoflurane, %50 air, and %50 oxygen, maintaining the bispectral index between 40 and 50.
Heart rate and blood pressure values will be titrated by increasing or decreasing the remifentanil infusion to ensure that the values remain within %20 of baseline or that the OAB remains above 65.
If the mean arterial pressure drops by more than %20, 5 mg of ephedrine will be administered.
At the end of the procedure, the surgical duration and the total intraoperative remifentanil dose administered will be recorded.
In the postoperative recovery room, patients who show no loss of sensation in the C5-C6 dermatome (over the deltoid muscle) on the pinprick test but report severe pain (VAS ≥ 4) will be considered to have had a failed block.
Under the postoperative analgesia protocol all patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device. The solution will be prepared such that morphine is 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time and all patients will be administered 1 gram of paracetamol at 8th 16th and 24th hours.
Patients will be randomly divided into 2 groups as Group K(Patients not receiving nonsteroidal anti-inflammatory drugs) and Group D(Patients receiving nonsteroidal anti-inflammatory drugs) In Group D (Patients receiving nonsteroidal anti-inflammatory drugs) cases, will be administered 25 miligram of dexketroprofen at 6th and 18th hours.
In the postoperative period, a researcher assessed the patient's visual pain scores (resting and movement), rebound pain intensity, timing, and duration, systolic blood pressure, mean arterial pressure, diastolic blood pressure, peripheral oxygen saturation, postoperative analgesic consumption, and postoperative complications will be recorded.
Patient follow-up will be concluded at the end of 24 hours.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Meryem Onay
- Número de telefone: 02222392979
- E-mail: dr.meryemonay@hotmail.com
Estude backup de contato
- Nome: Çağla Uzalp
- Número de telefone: 02222392979
- E-mail: caglauzalp@gmail.com
Locais de estudo
-
-
Odunpazarı
-
Eskişehir, Odunpazarı, Turquia (Türkiye), 26040
- Recrutamento
- Eskisehir Osmangazi Universıty Faculty of Medicine
-
Contato:
- Çağla Uzalp
- Número de telefone: 02222392979
- E-mail: caglauzalp@gmail.com
-
Contato:
- Meryem onay
- Número de telefone: 02222392979
- E-mail: drmeryemonay@hotmail.com
-
Investigador principal:
- Çağla Uzalp
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Age 18-70 years ASA score of I-III Arthroscopic shoulder surgery
Exclusion Criteria:
Patients who do not wish to participate in the study Creatinine clearance <50 mL/ min Patients for whom NSAID use is contraindicated due to heart failure, Patients with psychiatric or cognitive dysfunction that would impair their ability to assess visual analog scale (VAS) pain scores Patients for whom peripheral nerve block is contraindicated
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Group K
Under the postoperative analgesia protocol all patients will be administered 1 gr of paracetamol at 8th 16th and 24th hours and all patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device.
|
ISB + paracetamol IV 3*1
|
|
Comparador Ativo: Group D
Under the postoperative analgesia protocol all patients will be administered 1 gram of paracetamol at 8th 16th and 24th hours and all patients receiving nonsteroidal anti-inflammatory drugs (25 miligram of dexketroprofen) at 6th and 18th hours.
The patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device.
|
ISB+ paracetamol IV 3*1 +deksketoprofen IV 2*1. 25 miligram of dexketroprofen
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Effect of intravenous dexketoprofen administered during the postoperative period on the severity and incidence of rebound pain
Prazo: 24 hours
|
Rebound pain score(VAS ≥ 7) and incidence
|
24 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total opioid consumption
Prazo: 24 hours
|
Total morphine patient control analgesia prepared 0.5 mg / ml.
PCA 1 mg bolus dose will be delivered with 10 min lock-out time.
Follow up morphine consumption at postoperative 24 hours
|
24 hours
|
|
Visual analog Scale
Prazo: 24 hours
|
Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))
|
24 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: MERYEM ONAY, Eskisehir Osmangazi University Faculty Of Medıcıne
Publicações e links úteis
Publicações Gerais
- Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.
- Uppal V, Barry G, Ke JXC, Kwofie MK, Trenholm A, Khan M, Shephard A, Retter S, Shanthanna H. Reducing rebound pain severity after arthroscopic shoulder surgery under general anesthesia and interscalene block: a two-centre randomized controlled trial of pre-emptive opioid treatment compared with placebo. Can J Anaesth. 2024 Jun;71(6):773-783. doi: 10.1007/s12630-023-02594-0. Epub 2023 Oct 13.
- Singh NP, Makkar JK, Chawla JK, Sondekoppam RV, Singh PM. Prophylactic dexamethasone for rebound pain after peripheral nerve block in adult surgical patients: systematic review, meta-analysis, and trial sequential analysis of randomised controlled trials. Br J Anaesth. 2024 May;132(5):1112-1121. doi: 10.1016/j.bja.2023.09.022. Epub 2023 Oct 26.
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Esogü95
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .