Effect of Transversus Abdominis Plane (TAP) Block Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post Operative Pain Following Open Abdominal Cancer Surgery.
Postoperative Pain · Open Abdominal Cancer Surgery · Quality of Recovery · Chronic Postoperative Pain
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 70 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 72 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
This prospective, randomized, double-blind, controlled clinical trial is designed to evaluate whether adding magnesium sulfate to a dexamethasone-augmented, ultrasound-guided transversus abdominis plane (TAP) block improves early postoperative recovery and analgesia in adult patients undergoing open abdominal cancer surgery.
A total of 72 participants will be allocated into two groups. Both groups will receive a standard TAP block using bupivacaine and dexamethasone, while the intervention group will additionally receive magnesium sulfate.
The primary outcome of the study is the early quality of recovery assessed at 24 hours postoperatively. Secondary outcomes include postoperative pain scores, total opioid consumption, time to first rescue analgesia, the incidence of postoperative nausea and vomiting, patient satisfaction, block-related complications, intraoperative opioid requirements, hemodynamic parameters, and the incidence of chronic postoperative pain assessed through six months of follow-up.
¿Quién podría participar?
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Inclusion Criteria:
- •Age 18-70 years.
- ASA physical status I-III.
- Scheduled for elective abdominal cancer surgery.
- Able to understand the study protocol and complete the QoR-15 questionnaire. Provided written informed consent
Exclusion Criteria:
- • Patient refusal.
- Allergy to local anesthetics, dexamethasone, magnesium sulfate, or study medications.
- Coagulopathy or anticoagulant therapy.
- Local infection at the injection site.
- Severe hepatic or renal impairment.
- Neuromuscular disorders.
- Chronic opioid use or chronic pain syndromes.
- Pregnancy or lactation in females .
- BMI \>35 kg/m².
- Cognitive impairment or inability to communicate effectively.
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento cuádruple
Group D
Patients will receive bilateral ultrasound-guided TAP block using:20ml of 0.5% Bupivacaine 100mg mixed with 8mg dexamethasone (2ml) and diluted to 40ml with normal saline (18ml),20ml per side.
Drug: Bupivacaine · Drug: Dexamethasone
Group DM
Patients will receive bilateral ultrasound-guided TAP block using:20ml of 0.5% Bupivacaine 100mg mixed with 8mg dexamethasone (2ml),250mg magnesium sulfate (2.5ml) and diluted to 40ml with normal saline (15.5ml),20ml per side
Drug: Bupivacaine · Drug: Dexamethasone · Drug: Magnesium sulfate
Bupivacaine DRUG
Patients will receive bilateral ultrasound-guided TAP block using:20ml of 0.5% Bupivacaine 100mg total volume 40ml ,20ml volume per side in both groups.
Dexamethasone DRUG
Dexamethasone 8 mg will be administered as an adjunct to TAP block in both groups
Magnesium sulfate DRUG
Magnesium sulfate 250 mg will be administered as an adjunct to TAP block in DM group only
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Quality of Recovery-15 (QoR-15) score
Plazo: 24 hours postoperatively
The Quality of Recovery-15 questionnaire will be used to assess the quality of postoperative recovery 24 hours after surgery, evaluating five dimensions: physical comfort, emotional state, psychological support, physical independence, and pain, resulting in a total score ranging from 0 to 150 (higher scores indicate better recovery).
Medidas secundarias
Chronic Postoperative Pain
Plazo: Through 6 months postoperatively
Assessing the presence or absence of chronic postoperative pain and its intensity using the Visual Analogue Scale (VAS)ranging from 0 (no pain) to 10 (worst imaginable pain)minimum value of 0, maximum value of 10, where higher scores mean a worse outcome.
Postoperative Pain Intensity
Plazo: At arrival to Post- Anesthesia Care Unit (PACU) (0 hour), 2, 4, 6, 12, and 24 hours postoperatively.]
Evaluating postoperative pain intensity using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Time to First Request for Rescue Analgesia
Plazo: Within the first 24 hours postoperatively
Recording the duration from the end of surgery until the patient first requests rescue analgesia (when Visual Analogue Scale (VAS)is 4 or more).
Patient Satisfaction
Plazo: At 24 hours postoperatively
Evaluating patient satisfaction with postoperative pain management using a 5-point Likert scale (ranging from very dissatisfied to very satisfied)(minimum value of 1, maximum value of 5, where higher scores mean a better outcome).
TAP Block-Related Complications and Adverse Effects
Plazo: Intraoperatively and throughout the 24-hour postoperative period
Evaluating the overall incidence of any block-related complications or adverse events (including block failure, local anesthetic systemic toxicity, hematoma, infection, pneumothorax, nerve injury, or magnesium-related side effects), reported as the percentage of affected patients out of the total study population
Intraoperative Fentanyl Requirements
Plazo: Intraoperatively (during the surgical procedure)
Measuring the total intraoperative consumption of fentanyl.
Postoperative Nausea
Plazo: During the first 24 hours postoperatively
Recording the incidence of postoperative nausea episodes
Postoperative Vomiting
Plazo: During the first 24 hours postoperatively
Recording the incidence of postoperative vomiting episodes.
Total Postoperative Opioid Consumption
Plazo: During the first 24 hours postoperatively
Measuring the total morphine consumption required by the patient as rescue analgesia.
Heart rate
Plazo: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period)
Assessing heart rate values.
Mean Arterial Pressure (MAP)
Plazo: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period).
Assessing Mean Arterial Pressure (MAP) values
Oxygen Saturation (SpO2)
Plazo: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period)
Assessing peripheral oxygen saturation levels.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
South Egypt Cancer Institute, Assiut University, EgyptAsyut, EgyptEstado desconocido
Equipo y fechas
- Patrocinador principal
- Assiut University
- Inicio del estudio
- 1 dic 2026 Estimado
- Finalización primaria
- 1 dic 2028 Estimado
- Finalización del estudio
- 1 dic 2028 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Effect of Magnesium Sulfate Added to Dexamethasone-Augmented Ultrasound-Guided Transversus Abdominis Plane (TAP) Block on Early Quality of Recovery and Chronic Post Operative Pain Following Open Abdominal Cancer Surgery: A Prospective Randomized Double-Blind Controlled Trial
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026
