Opioid Free AnesthesiaNCT05312541
A Comparative Study Between Analgesic Effect of Opioid Free and Opioid Based Anesthesia in Radical Nephrectomy Surgery
A study testing pre emptive local anaesthetic wound infiltration in people with Opioid Free Anesthesia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Free Anesthesia
- What is being tested?
- pre emptive local anaesthetic wound infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2022to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender both males and females
- ASA Class II
- Age 18-70 years
- Patients undergoing open radical nephrectomy
Who cannot join
- 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) )
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy, Cairo University
Cairo, 202
Ahmed nabih, lecturer, 01002773488 ext. 202, nabihomar100@yahoo.com
About this study
Official title: A Comparative Study Between Analgesic Effect of Opioid Free and Opioid Based General Anesthesia Technique in Patients Undergoing Open Radical Nephrectomy Surgery.A Prospective Randomized Controlled Trial
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.
Read more
Objectives:
- To evaluate analgesic effect of each group intra operative {heart rate, and systolic and diastolic blood pressure }
- To evaluate analgesic effect of each group post operative [total opioid consumption in 24h postoperative , Postoperative VAS , hemodynamic).
- To estimate the incidence of early postoperative complication in both groups
Read the detailed description
This a randomized control trial is designed to include (74) patients ASA physical status II patients ranging from(18) to(70)years old scheduled for open radical nephrectomy
Patients meeting the inclusion criteria will be randomly assigned to receive either :
Group I :Opioid Based Anesthesia (n=37) GroupII: Opioid Free Anesthesia:(n=37) Anesthesia management
Preoperative procedures:
Full history and investigation will be taken in the form of complete blood count , blood sugar,liver function tests. Kidney function tests ,electrolytes and coagulation profile. Pre induction of general anesthesia with gabapentin 300 mg tab or placebo 1 h before surgery while gabapentin in (Opioid free Anesthesia) and placebo in (Opioid Based Anesthesia) . After securing IV access by 20G cannula, all patients will receive 0.05mg/kg midazolam for anxiety. Ranitidine 50mg, metoclopramide 10mg and antibiotic 50mg/kg as a premedication.Intraoperative monitoring includes ASA standard monitoring Electrocardiography (ECG), noninvasive blood pressure, pulse oximetry for O2 saturation, end-tidal carbon dioxide (CO2) values by capnography.
Intraoperative procedures:
Induction of general anesthesia in both groups will be done by 2mg \kg propofol, and 0.5mg\kg atracurium. to facilitate endotracheal intubation, with fentanyl1ug/kg/ iv then infusion of 1 ug/kg/h in group I (Opioid Based Anesthesia) and 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 in group II (Opioid Free Anesthesia) after induction.
Anesthesia maintenance will be achieved in both group with endotracheal tube (ETT) with suitable size, 1.2 minimium alveolar concentration of isoflurane, volume controlled mode ventilation, respiratory rate will be adjusted according to Et CO2 to range between 35-40 mmHg, a tidal volume of 6-8 ml/kg and mixture of gases in proportion 50% oxygen and 50% air, with positive end expiratory pressure (PEEP) 5 cm H2O and0.1 mg\kg atracurium every 30 min.
Intervention 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. By the end of surgery, anaesthesia will be discontinued ,patient will be reversed by neostigmine 0.05mg\kg and atropine0.02mg\kg, extubation will be done and patient will be transferred to post anaesthesia care unit (PACU).
Postoperative
- The pain assessment after full recovery will be performed using a 10 cm visual analog scale (VAS) (0- no pain and 10 cm maximum pain) .Postoperative pain assessments using VAS at 0 point (the full recovery state which is defined as a state of consciousness of individual when he is awake or easily arousable and aware of his surroundings and identity, 2 hr, 6 hr, 12 hr, and at 24 hr. IV paracetamol 1 g every 6 hours will be administered for both groups. The time to first request of postoperative analgesic is defined as( the time interval from tracheal extubation to first dose of morphine adminstration) will be recorded .Rescue postoperative analgesic will be administrated if VAS ≥ 4 at rest or on patient's demand with IV morphine sulphate 0.03 mg/kg with maximum dose 20 mg per day in both groups .the total amount of morphine in the first postoperative 24 hours will be calculated in both groups.
- Post operative hemodynamic will be assessed(heart rate ,systolic and diastolic blood pressure at the same time point)
- Incidence of complication will be assessed:
- Nausea and vomiting
- Respiratory complications(bronchospasm , laryngospasm , respiratory depression)
Measurement tools
- Patients demographic data will be collected; age, gender, and duration of anesthesia
- Intraoperative hemdynamic (Heart rate ,systolic and diastolic blood pressure).
- Postoperative pain assessments using VAS at at 0 point (the full recovery state), 2 hr, 6 hr, 12 hr, and at 24 hr
- Time to first request of rescue postoperative analgesic
- Total opioid consumption in 24 h postoperative
- Postoperative hemdynamic (Heart rate ,systolic and diastolic blood pressure at the same time point)
- Conditions
- Opioid Free Anesthesia
- Being tested
- pre emptive local anaesthetic wound infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre emptive local anaesthetic wound infiltrationProcedure or surgery
Also called xylocaine and bupivacaine local anaesthetic mixture
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: pre emptive local anaesthetic wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Time to first request of opioid analgesia
the time interval between tracheal extubation and the first request to postoperative analgesia
Measured: 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
total amount of morphine in the first postoperative 24 hours
Measured: the total amount of morphine in the first postoperative 24 hours will be calculated
Postoperative VAS score
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: Postoperative pain assessments using VAS at 0 point (the full recovery state ), 2 hours, 6 hours, 12 hours,and at 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start10 Apr 2022
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Free AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Ahmed nabih youssef, Kasr El Aini Hospital
- Investigators
- Heba ismail, professor, Study director, Anesthesia department , Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312541
- Sponsor's protocol ID
- N-2-2022
- Status last verified
- May 2022
- First submitted
- 12 Mar 2022
- Last updated
- 10 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Analgesic Effect of Opioid Free and Opioid Based General Anesthesia Technique in Patients Undergoing Open Radical Nephrectomy Surgery.A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05312541
- Acronym / sponsor ID
- N-2-2022
- Conditions
- Opioid Free Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate analgesic effect of each group intra operative {heart rate, and systolic and diastolic blood pressure }
- To evaluate analgesic effect of each group post operative [total opioid consumption in 24h postoperative , Postoperative VAS , hemodynamic).
- To estimate the incidence of early postoperative complication in both groups
Detailed description
This a randomized control trial is designed to include (74) patients ASA physical status II patients ranging from(18) to(70)years old scheduled for open radical nephrectomy
Patients meeting the inclusion criteria will be randomly assigned to receive either :
Group I :Opioid Based Anesthesia (n=37) GroupII: Opioid Free Anesthesia:(n=37) Anesthesia management
Preoperative procedures:
Full history and investigation will be taken in the form of complete blood count , blood sugar,liver function tests. Kidney function tests ,electrolytes and coagulation profile. Pre induction of general anesthesia with gabapentin 300 mg tab or placebo 1 h before surgery while gabapentin in (Opioid free Anesthesia) and placebo in (Opioid Based Anesthesia) . After securing IV access by 20G cannula, all patients will receive 0.05mg/kg midazolam for anxiety. Ranitidine 50mg, metoclopramide 10mg and antibiotic 50mg/kg as a premedication.Intraoperative monitoring includes ASA standard monitoring Electrocardiography (ECG), noninvasive blood pressure, pulse oximetry for O2 saturation, end-tidal carbon dioxide (CO2) values by capnography.
Intraoperative procedures:
Induction of general anesthesia in both groups will be done by 2mg \kg propofol, and 0.5mg\kg atracurium. to facilitate endotracheal intubation, with fentanyl1ug/kg/ iv then infusion of 1 ug/kg/h in group I (Opioid Based Anesthesia) and 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 in group II (Opioid Free Anesthesia) after induction.
Anesthesia maintenance will be achieved in both group with endotracheal tube (ETT) with suitable size, 1.2 minimium alveolar concentration of isoflurane, volume controlled mode ventilation, respiratory rate will be adjusted according to Et CO2 to range between 35-40 mmHg, a tidal volume of 6-8 ml/kg and mixture of gases in proportion 50% oxygen and 50% air, with positive end expiratory pressure (PEEP) 5 cm H2O and0.1 mg\kg atracurium every 30 min.
Intervention 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. By the end of surgery, anaesthesia will be discontinued ,patient will be reversed by neostigmine 0.05mg\kg and atropine0.02mg\kg, extubation will be done and patient will be transferred to post anaesthesia care unit (PACU).
Postoperative
- The pain assessment after full recovery will be performed using a 10 cm visual analog scale (VAS) (0- no pain and 10 cm maximum pain) .Postoperative pain assessments using VAS at 0 point (the full recovery state which is defined as a state of consciousness of individual when he is awake or easily arousable and aware of his surroundings and identity, 2 hr, 6 hr, 12 hr, and at 24 hr. IV paracetamol 1 g every 6 hours will be administered for both groups. The time to first request of postoperative analgesic is defined as( the time interval from tracheal extubation to first dose of morphine adminstration) will be recorded .Rescue postoperative analgesic will be administrated if VAS ≥ 4 at rest or on patient's demand with IV morphine sulphate 0.03 mg/kg with maximum dose 20 mg per day in both groups .the total amount of morphine in the first postoperative 24 hours will be calculated in both groups.
- Post operative hemodynamic will be assessed(heart rate ,systolic and diastolic blood pressure at the same time point)
- Incidence of complication will be assessed:
- Nausea and vomiting
- Respiratory complications(bronchospasm , laryngospasm , respiratory depression)
Measurement tools
- Patients demographic data will be collected; age, gender, and duration of anesthesia
- Intraoperative hemdynamic (Heart rate ,systolic and diastolic blood pressure).
- Postoperative pain assessments using VAS at at 0 point (the full recovery state), 2 hr, 6 hr, 12 hr, and at 24 hr
- Time to first request of rescue postoperative analgesic
- Total opioid consumption in 24 h postoperative
- Postoperative hemdynamic (Heart rate ,systolic and diastolic blood pressure at the same time point)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Based Anesthesia | Placebo comparator | Procedure: pre emptive local anaesthetic wound infiltrationPre 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 |
| opioid free anesthesia | Active comparator | Procedure: pre emptive local anaesthetic wound infiltrationPre 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gender both males and females
- ASA Class II
- Age 18-70 years
- Patients undergoing open radical nephrectomy
Key exclusion criteria (4 listed)
- 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) )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre emptive local anaesthetic wound infiltrationAlso: xylocaine and bupivacaine local anaesthetic mixtureBefore 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 | Procedure or surgery | Opioid Based Anesthesia, opioid free anesthesia |
Primary outcome
The Time to first request of opioid analgesia
Time frame: 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
the time interval between tracheal extubation and the first request to postoperative analgesia
2 secondary outcomes
Total opioid consumption
Time frame: the total amount of morphine in the first postoperative 24 hours will be calculated
Postoperative VAS score
Time frame: Postoperative pain assessments using VAS at 0 point (the full recovery state ), 2 hours, 6 hours, 12 hours,and at 24 hours postoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heba ismail, professor study director
Anesthesia department , Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre emptive local anaesthetic wound infiltration in people with Opioid Free Anesthesia, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed nabih, lecturer (01002773488 ext. 202, nabihomar100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Time to first request of opioid analgesia (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.