Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838314
Status:
TERMINATED
Last Update Posted:
2023-08-21
First Post:
2021-04-01
Brief Title:
Perioperative Analgesia by ESP Catheter on Paediatric Recipient for Liver Transplantation
Sponsor:
Vinmec Healthcare System
Organization:
Vinmec Healthcare System
Study Overview
Official Title:
Does Bilateral Continuous Peri Operative Erector Spinae Plane ESP Block Improve Analgesia and Reduce Opioid Consumption for Liver Transplantation in Recipient Paediatric Patient
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No More recruitment surgeon left the team
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESPLIVPAED
Brief Summary:
Pediatric Liver transplantation surgery is associated with moderate to severe postoperative pain that is related to large abdominal incision cutting muscles and fascia and the anterior abdominal wall and drains Peri-operative pain management after this surgery is centered on intravenous opioids which cannot provide complete pain relief and are responsible for side effects such as vomiting or respiratory depression Fifty-two per cent of pediatric patients reported moderate to severe pain on the day of surgery and 33 on day 1 42 of patients reported vomiting Increasing interest has focused on opioid sparing analgesic strategies to avoid some of the detrimental side effects of opioids Recently the focus has been on postoperative regional analgesia after major pediatric in major thoracic or abdominal surgeries Thoracic epidural anesthesia or paravertebral blocks are efficacious but raise some concerns related to their potential complications especially in Liver transplantation with the risk of coagulation disorders
Erector spinae plane block ESPB is an interfascial plane block whereby Local anesthestic LA is injected beneath the iliocostalis longissimus and spinalis muscles to achieve multi metameric analgesia for pediatric thoracic cardiac or abdominal surgery
I Investigators hypothesis is with efficient peri operative regional analgesia will reduce the opioids consumption allow a very early extubation after such long surgeries and improve the quality of recovery by reducing the side effects of opioids as sedation nausea vomiting delay of first intake
Erector spinae plane block ESPB is an interfascial plane block whereby Local anesthestic LA is injected beneath the iliocostalis longissimus and spinalis muscles to achieve multi metameric analgesia for pediatric thoracic cardiac or abdominal surgery
I Investigators hypothesis is with efficient peri operative regional analgesia will reduce the opioids consumption allow a very early extubation after such long surgeries and improve the quality of recovery by reducing the side effects of opioids as sedation nausea vomiting delay of first intake
Detailed Description:
1 Goals
Compare quality of analgesia and quality of recovery between bilateral ESP bilateral catheters versus Opioid analgesia in paediatric patients for liver transplantation reduce the peri operative opioid consumption
2 Methodology
Selection criteria
Age 1 to 15 years old
Have a clinical indication for Liver transplantation list for surgeries listed in full proposal
Agree to participate in the trial Parents or guardians
Exclusion criteria
Refusal participation
Allergy to LA
Intubated ventilated pre-operation
Severe coagulation disorder
Coma
Prediction of large volume liver implanted
After surgery performed
Large volume implanted with a need of post operative controlled ventilation
Organ failure
Unstable patient
Study design Prospective Randomized Controlled Trial
Patients who agree to join the study will be randomized into 2 groups
Group 1 Control group standard of care in Liver Transplantation for paediatric recipients Intra-operative analgesia by Opioid sufentanil and post operative analgesia by patient controled analgesia assisted by nurse opioid morphine based on the protocol established by Prof Lee Vinmec transplantation surgical committee Group 2 treatment group Standard peri-operative analgesia for paediatric recipients in institution since we use regional anaesthesia as first line treatment for peri-operative analgesia Bilateral ESP catheters with continuous regional analgesia by infusion of local anesthestic Ropivacaine based on the guidelines by paediatric society of anesthesiologists and based on our recent article published in regional anaesthesia and pain medicine
Sample size We expected to reduce the peri operative opioid consumption by 85 for liver receipt The sample size of 10 patients per group is required to detect such changes assuming a confidence interval of 95 with a power of 90 and alpha 005 Considering 20 of drop-out the total sample size is 40 patients 20 patients each group
3 Project outcomes
The Primary outcome correlation between
Pain quality evaluated by
Opioids consumption The secondary outcomes
Time to extubate
Time to discharge from Intensive care Unit ICU we will create criteria to determinate when patient will discharge from ICU to go to high dependency In most of advanced hospital they dont keep a long time patient in ICU and send the patient to high dependency unit in surgery As in Institution we dont have we will keep the patient in ICU
Time to discharge from hospital
Time to first intake
Any complication related to one type of analgesia
Compare quality of analgesia and quality of recovery between bilateral ESP bilateral catheters versus Opioid analgesia in paediatric patients for liver transplantation reduce the peri operative opioid consumption
2 Methodology
Selection criteria
Age 1 to 15 years old
Have a clinical indication for Liver transplantation list for surgeries listed in full proposal
Agree to participate in the trial Parents or guardians
Exclusion criteria
Refusal participation
Allergy to LA
Intubated ventilated pre-operation
Severe coagulation disorder
Coma
Prediction of large volume liver implanted
After surgery performed
Large volume implanted with a need of post operative controlled ventilation
Organ failure
Unstable patient
Study design Prospective Randomized Controlled Trial
Patients who agree to join the study will be randomized into 2 groups
Group 1 Control group standard of care in Liver Transplantation for paediatric recipients Intra-operative analgesia by Opioid sufentanil and post operative analgesia by patient controled analgesia assisted by nurse opioid morphine based on the protocol established by Prof Lee Vinmec transplantation surgical committee Group 2 treatment group Standard peri-operative analgesia for paediatric recipients in institution since we use regional anaesthesia as first line treatment for peri-operative analgesia Bilateral ESP catheters with continuous regional analgesia by infusion of local anesthestic Ropivacaine based on the guidelines by paediatric society of anesthesiologists and based on our recent article published in regional anaesthesia and pain medicine
Sample size We expected to reduce the peri operative opioid consumption by 85 for liver receipt The sample size of 10 patients per group is required to detect such changes assuming a confidence interval of 95 with a power of 90 and alpha 005 Considering 20 of drop-out the total sample size is 40 patients 20 patients each group
3 Project outcomes
The Primary outcome correlation between
Pain quality evaluated by
Opioids consumption The secondary outcomes
Time to extubate
Time to discharge from Intensive care Unit ICU we will create criteria to determinate when patient will discharge from ICU to go to high dependency In most of advanced hospital they dont keep a long time patient in ICU and send the patient to high dependency unit in surgery As in Institution we dont have we will keep the patient in ICU
Time to discharge from hospital
Time to first intake
Any complication related to one type of analgesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None