- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01534416
Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery
Use of Paracervical Block in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
A variety of traditionally open surgical procedures have recently become minimally invasive through the use of laparoscopic technology. Gynecologic surgeries are no exception. However, some gynecologic laparoscopic procedures are associated with significant post-operative pain, necessitating prolonged hospitalization, use of post-operative opioids, and in some cases, the development of chronic post-operative pain. Prolonged hospitalization and use of opioids pose important patient safety concerns, such as increased risk of hospital borne illnesses and medication errors; in addition, opioids may cause respiratory depression and addiction. Given the rising cost of health care there is also an economic incentive to eliminate the need for hospital admission due to post-operative pain.
Preemptive analgesia involves nerve blockade or administration of pain medication systemically prior to incision to reduce post-procedure pain. Paracervical blockade is a form of preemptive analgesia. Paracervical blocks have been demonstrated to be safe and effective for obstetrical procedures in reducing post-operative pain since the 1970s. Recently they have also been shown to be efficacious for reducing post-operative pain in vaginal hysterectomy (Long et al, Int Urogynecol J (2009) 20:5-10).
For the present investigation, we intend to study the effectiveness of paracervical blockade for laparoscopic and robotic-assisted laparoscopic gynecological surgery. We hypothesize that paracervical blockade prior to surgical incision will lessen levels of post-operative pain, reduce use of opioids, and decrease the number of patients requiring hospitalization for pain control. We also hypothesize that the effects may be longer lasting than the immediate post-operative period and may decrease the amount of time to return to normal activity after surgery.
Using anecdotal evidence from the primary investigator, Dr. Ascher-Walsh the rate of hospitalization for laparoscopic hysterectomy (laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, laparoscopic assisted supracervical hysterectomy) is approximately 67%. In this study, we wish to decrease hospitalization with the paracervical block by 50%, thus obtaining an overall post-operative hospitalization rate of 33%. For robotic-assisted laparoscopic myomectomy, the rate of hospitalization is 50%. We wish to decrease this by 50% as well. Overall we are aiming to achieve a rate of 30% for post-operative hospitalization for pain control for laparoscopic hysterectomies and robotic myomectomies combined.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Female
- Age 18 or older
- Scheduled for robotic-assisted laparoscopic myomectomy or laparoscopic hysterectomy, including total and supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy
- Surgery being performed for benign disease
Exclusion Criteria:
- Male
- Women under 18 years old
- Pregnancy
- Suspected or known malignant disease
- Immunocompromised
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Bupivacaine
Subjects receive paracervical block with bupivacaine-epinephrine
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Subjects are injected paracervically with 10 ml of 0.5% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
Outros nomes:
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Comparador de Placebo: Saline
Subjects receive paracervical injection of normal saline
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Subjects are injected paracervically with 10 ml of normal saline prior to surgical incision.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants With Hospital Admission for Postoperative Pain Control
Prazo: Four hours after conclusion of surgery
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Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management
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Four hours after conclusion of surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postoperative Pain Score
Prazo: 1and 2 hour postoperatively
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Postoperative pain levels assessed using the visual analogue pain scale.
This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain.
In the PACU pain assessed using this scale by the nursing staff.
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1and 2 hour postoperatively
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Postoperative Pain Score
Prazo: 1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative
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Postoperative pain levels assessed using the visual analogue pain scale.
This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain.
In the PACU pain assessed using this scale by the nursing staff.
On postoperative days 1 and 2 the subjects self-reported their pain level.
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1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative
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Postoperative Day Pain Medication Use
Prazo: Postoperative days 0-10
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Numbers of Patients Using Pain Medication on Postoperative Days 1-10.
The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively.
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Postoperative days 0-10
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Charles Ascher-Walsh, MD, Icahn School of Medicine at Mount Sinai
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
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
- GCO 11-0021
- HS# 11-00013
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