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A Comparative Study Between Analgesic Effect of Opioid Free and Opioid Based Anesthesia in Radical Nephrectomy Surgery

NCT05312541 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-05-10

No results posted yet for this study

Summary

Patients undergoing nephrectomy have a high incidence of postoperative pain. In the perioperative period, these patients are often treated with patient-controlled opioids, epidural analgesia, or both. While effective, both of these treatment modalities carry risk, ie, opioids have a side effect profile including pruritus, nausea,vomiting, increase the risk of oversedation and apnea in patients at risk (eg, those with sleep apnea), difficulty in voiding, and ileus. These complications may lead to a prolonged hospital stay. High dose opioids can also cause acute opioid tolerance and hyperalgesia. Epidurals have been associated with hypotension, post dural puncture headaches, changes in management of anticoagulation Opioid free anesthesia (OFA) is a technique in which no intraoperative opioid administered through any route, including systemic, neuraxial, or tissue infiltration.Opioid free anesthesia has many advantages especially avoiding opioid overdose and opioid-induced hyperalgesia. The most important advantage of OFA seems to be the potential improvement of recovery profile in obese patients. OFA depends on combinations of non-opioid agents and adjuncts, including propofol, lidocaine, magnesium, dexmedetomidine, and ketamine to produce anesthesia, and analgesia.

Aim of the work our study aim to compare the analgesic effect of OFA and opioid based general anesthesia using pre emptive wound infiltration in patients undergoing open radical nephrectomy surgery.

Objectives:

1. To evaluate analgesic effect of each group intra operative {heart rate, and systolic and diastolic blood pressure }
2. To evaluate analgesic effect of each group post operative \[total opioid consumption in 24h postoperative , Postoperative VAS , hemodynamic).
3. To estimate the incidence of early postoperative complication in both groups

Conditions

  • Opioid Free Anesthesia

Interventions

PROCEDURE

pre emptive local anaesthetic wound infiltration

Before skin incision by 15 min the surgeon will infiltrate the wound by syringe containing 20 ml mixture of (10 ml xylocaine 2%and 10 ml bupivacaine 0. 5%) in both groups

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Kasr El Aini Hospital

    lead OTHER

Principal Investigators

  • Heba ismail, professor · Anesthesia department , Cairo university

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-10
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Egypt

Study Locations

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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 NCT05312541 on ClinicalTrials.gov