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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

LO ESENCIAL

De qué trata este estudio

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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.
Entiende la evaluación inicial

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

Prepara tus preguntas

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.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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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

Madona M Noman, MDCONTACTmadonamisheal90@yahoo.com201006265867
Romany G Gendy, MDCONTACTromanygergis@aun.edu.eg201229869146
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

EL PRÓXIMO PASO, CON APOYO HUMANO

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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