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

NCT05312541 | Unknown

• 1 other identifier: N-2-2022
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Opioid Free Anesthesia

Outcome Measures

Primary Outcomes (1)

• The Time to first request of opioid analgesia

  the time interval between tracheal extubation and the first request to postoperative analgesia

  it will be measured from tracheal extubation to first request of postoperative analgesia in the first 24 hours postoperative and it will be expressed in minutes

Secondary Outcomes (2)

• Total opioid consumption

  the total amount of morphine in the first postoperative 24 hours will be calculated

• Postoperative VAS score

  Postoperative pain assessments using VAS at 0 point (the full recovery state ), 2 hours, 6 hours, 12 hours,and at 24 hours postoperative.

Study Arms (2)

Opioid Based Anesthesia

PLACEBO COMPARATOR

Pre induction of general anesthesia with placebo 1 h before surgery. induction of general anesthesia with fentanyl1ug/kg/ iv then infusion of 1 ug/kg/h

Procedure: pre emptive local anaesthetic wound infiltration

opioid free anesthesia

ACTIVE COMPARATOR

Pre induction of general anesthesia with gabapentin 300 mg tab 1 h before surgery. induction of general anesthesia with ketamine 0.5 mg/kg iv, Lidocaine 1 mg/kg iv then continuous infusion with 2 mg/kg/hr, dexamethasone 0.1 mg/kg.iv, magnesium sulfate 20 mg/kg.iv

Procedure: pre emptive local anaesthetic wound infiltration

Interventions

pre emptive local anaesthetic wound infiltration PROCEDURE

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

Also known as: xylocaine and bupivacaine local anaesthetic mixture

Opioid Based Anesthesia; opioid free anesthesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender both males and females
• ASA Class II
• Age 18-70 years
• Patients undergoing open radical nephrectomy

You may not qualify if:

• Allergy to local anesthetic
• Infection of the skin at the site of local infiltration
• Cvs problem(ischemic heart disease,arrhythmias{heart block, supraventricular tachyarrhythmia (SVT),atrial fibrillation (AF),multiple extra systole)
• Liver and renal impairment(elevated liver enzymes (ALT, AST two to three fold), chronic renal failure (CRF) )

Sponsors & Collaborators

• Kasr El Aini Hospital: lead
• Cairo University: collaborator

Study Sites (1)

Kasr Alainy, Cairo University

Cairo, 202, Egypt

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Heba ismail, professor

  Anesthesia department , Cairo university

  STUDY DIRECTOR

Central Study Contacts

Ahmed nabih, lecturer

CONTACT

01002773488; nabihomar100@yahoo.com

mohamed abdel ghany, lecturer

CONTACT

01016109777; dr.mohmed.elshazly8686@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done by computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelopes will be opened by the nurse, the card inside will determine the patient group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: April 5, 2022
• Study Start: April 10, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)