MedTrace Logo

Analgesic Requirements for Lumbar Fixation With General Anaesthesia Versus Continuous Caudal Epidural

NCT06929611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-16

No results posted yet for this study

Summary

In this clinical study, the investigators will justify the current practice of combined continuous caudal epidural with general anaesthesia in adult patients undergoing lumbar fixation versus general anaesthesia. Furthermore, the investigators will determine the analgesic requirement, rescue analgesia, hemodynamic changes and possible complications with continuous caudal epidural analgesia.

Conditions

  • Analgesia

Interventions

OTHER

Combined continous caudal epidural with general anaesthesia

A 17- or 18-gauge Tuohy-type needle will be inserted in the midline into the caudal canal. An initial dose of 20 ml of 0.25% bupivacaine will be injected in the caudal canal in order to perform sensory block and spare motor power. Then a dose of 10 ml 0.25% bupivacaine will be injected through the epidural catheter every 1-hour intra operatively and at 0-hour and 1-hour post operative then the catheter will be removed 1 hour post operative. -The following factors will be assessed: 1. Intra operative heart rate and blood pressure. 2. Post operative pain assessment according to numeric pain scale score. 3. Time to rescue analgesia (intravenous analgesia administered after surgery).Patients with numeric pain scale score ≥ 3 at any point of time, will receive intravenous morphine 5mg. 4. Estimated blood loss and surgeon satisfaction of surgical field. 5. Total intra operative and post operative analgesia. 6. Common complications.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Omar Zafer, MD · Faculty of Medicine Ain Shams University

  • Paula Samaan, MD · Faculty of Medicine Ain Shams University

  • Ahmed El-Hennawy, MD · Faculty of Medicine Ain Shams University

  • Mahmoud Ghallab, MD · Faculty of Medicine Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06929611 on ClinicalTrials.gov