Ignite Creation Date:
2024-05-06 @ 3:28 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02293330
Status:
COMPLETED
Last Update Posted:
2016-11-23
First Post:
2014-10-30
Brief Title:
Continuous Versus Automated Bolus Infusion in Sciatic Nerve Catheters
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Continuous Infusion Versus Automated Intermittent Bolus of Levobupivacaine 01 in Ultrasound Guided Subparaneural Sciatic Nerve Catheters A Prospective Double Blind Randomised Study
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is developed to determine if the local anaesthetic dose can be reduced by the use of intermittent bolus technique compared to continuous infusion when the nerve catheter is placed underneath the paraneurium by ultrasound guidance in the popliteal fossa Our primary outcome is local anesthetic use the first 48 hours after connecting the peripheral nerve catheter Our hypothesis is that with an intermittent bolus less local anaesthetic is necessary the first postoperative 48 hours after surgery for adequate postoperative analgesia As secondary outcomes the investigators study pain scores motor block sensory block feeling of numbness patient satisfaction sleep quality and rescue analgesia during the nerve block and afterwards
Detailed Description:
Patients scheduled for foot surgery under general anaesthesia and a popliteal nerve catheter will be asked to take part and give informed consent The anaesthesiologist performing the block the patient and the independent observer will be blinded to the study group and the settings of the pump CADD-Solis will be regulated and the data collected after 48 hours by an independent pain nurse or anaesthetist who is aware of the study group but does not register any other parameters
Patients will be randomised by a computer-generated sequence concealed by sealed envelopes The envelope will be opened and the pump prepared by an independent pain nurse or anaesthesiologist who will not participate in registration of the parameters except extracting information out of the pump when the catheter is removed
We expect to detect a 20 increase in local anaesthetic dose for the continuous administration group 230 mg48 hour We used a standard deviation of 2558 mg from a previous study The minimum sample size required is 20 patients per group for a power of 80 with a 2-tailed significance level of 5 We decided to include 25 patients in each group
Before surgery
An IV access and standard monitoring is used throughout the procedure A pre puncture scan will be performed and an experienced anaesthesiologist will perform all blocks The block is performed in the lateral decubitus with a 12-18 MHz megahertz linear probe BK medical and a solo long needle-catheter set Pajunk18 gauge needle 20 gauge catheter The nerve will be visualised in a short axis image and the puncture will be done out of plane Confirmation of accurate needle tip position will be confirmed by injection of nacl 09 sodium chloride and the appearance of a twin- or triple halo sign After confirmation of correct needle tip position 15 ml levobupivacaine 025 chirocaine Abbotwill be injected in between de peroneal and tibial nerve as an initial bolus After injection a will be advanced 4 cm beyond the needle tip
Correct catheter placement will be confirmed by ultrasound A detailed description of block performance will be registered according to our standard hospital policy The sensory block of the peroneal and tibial nerve will be separately tested by loss of cold sensation before transfer to the operating room at least 20 minutes after the initial injection of lidocaine When no block is detected it is considered as a block failure and the patient will be excluded from the study
After performing the popliteal block the patients will be transferred to the operating room and receive general anaesthesia by an independent anaesthesiologist Surgery will be performed with a tourniquet at 300 mm Hg Standard monitoring is used during surgery ecg pulse oximetry and non invasive blood pressure measurement Duration of surgery will be registered
After the operation the patient will be transferred to the recovery room Here the popliteal catheter will be connected pain pump which will be defined as t0 with an infusion protocol according to the study group
C group continuous infusion of levobupivacaine 0125 chirocaine Abbot B group Intermittent bolus of levobupivacaine 0125 chirocaineAbbot Both groups will have the possibility of administering a pca patient controlled analgesia bolus of 6 ml
The Pump CADD-Solis Smiths medical which will be started in the recovery room by an independent pain nurse or anaesthetist who is aware of the appointed study group C group or B group Pain scores motor blocksensory block and presence of numbness will be registered when the patient is awake enough to evaluate these parameters
The patient will then be transferred to the ward after clear instructions of how to use the pain pumpThe study will continue until 48 hours after starting the pump Pain scores will be registered every four hours at the ward as well as feeling of numbness and sleep quality at regular intervals During night hours 00-06when the patient is sleeping pain scores will be registered as SWhen pain control is insufficient at the PACU or on the ward patients will receive paracetamol 1gr IVParacetamol and ketorolac taradyal 30 mg IV Tramadol contramal 2 mgkg will be given as rescue analgesia On day one rescue analgesia will be provided orally
All rescue analgesia or other medication will be registered
48 hours after starting the pain pump the pump will be removed and all data will be collected and filed by an independent pain nurse or anaesthetist This file will consist of a detailed description of the history of local anaesthetic administered including total anaesthetic dose at 61224 and 48 hours frequency of extra boluses required and time intervals
Before removing the nerve catheter the depth of the catheter is checked and bolus of nacl will be infused under ultrasound guidance and if possible correct placement can be confirmed after two days Then the catheter will be removed
After stopping the pump the patient will be asked if he or she was satisfied by the postoperative analgesic technique
1 Satisfied
2 Sufficient
3 Not satisfied
The patient is discharged but is asked to register the exact time point when sensation and motor function when a motor block was present after catheter removal appeared The patient will be called two days after discharge to register these parameters
Patients will be randomised by a computer-generated sequence concealed by sealed envelopes The envelope will be opened and the pump prepared by an independent pain nurse or anaesthesiologist who will not participate in registration of the parameters except extracting information out of the pump when the catheter is removed
We expect to detect a 20 increase in local anaesthetic dose for the continuous administration group 230 mg48 hour We used a standard deviation of 2558 mg from a previous study The minimum sample size required is 20 patients per group for a power of 80 with a 2-tailed significance level of 5 We decided to include 25 patients in each group
Before surgery
An IV access and standard monitoring is used throughout the procedure A pre puncture scan will be performed and an experienced anaesthesiologist will perform all blocks The block is performed in the lateral decubitus with a 12-18 MHz megahertz linear probe BK medical and a solo long needle-catheter set Pajunk18 gauge needle 20 gauge catheter The nerve will be visualised in a short axis image and the puncture will be done out of plane Confirmation of accurate needle tip position will be confirmed by injection of nacl 09 sodium chloride and the appearance of a twin- or triple halo sign After confirmation of correct needle tip position 15 ml levobupivacaine 025 chirocaine Abbotwill be injected in between de peroneal and tibial nerve as an initial bolus After injection a will be advanced 4 cm beyond the needle tip
Correct catheter placement will be confirmed by ultrasound A detailed description of block performance will be registered according to our standard hospital policy The sensory block of the peroneal and tibial nerve will be separately tested by loss of cold sensation before transfer to the operating room at least 20 minutes after the initial injection of lidocaine When no block is detected it is considered as a block failure and the patient will be excluded from the study
After performing the popliteal block the patients will be transferred to the operating room and receive general anaesthesia by an independent anaesthesiologist Surgery will be performed with a tourniquet at 300 mm Hg Standard monitoring is used during surgery ecg pulse oximetry and non invasive blood pressure measurement Duration of surgery will be registered
After the operation the patient will be transferred to the recovery room Here the popliteal catheter will be connected pain pump which will be defined as t0 with an infusion protocol according to the study group
C group continuous infusion of levobupivacaine 0125 chirocaine Abbot B group Intermittent bolus of levobupivacaine 0125 chirocaineAbbot Both groups will have the possibility of administering a pca patient controlled analgesia bolus of 6 ml
The Pump CADD-Solis Smiths medical which will be started in the recovery room by an independent pain nurse or anaesthetist who is aware of the appointed study group C group or B group Pain scores motor blocksensory block and presence of numbness will be registered when the patient is awake enough to evaluate these parameters
The patient will then be transferred to the ward after clear instructions of how to use the pain pumpThe study will continue until 48 hours after starting the pump Pain scores will be registered every four hours at the ward as well as feeling of numbness and sleep quality at regular intervals During night hours 00-06when the patient is sleeping pain scores will be registered as SWhen pain control is insufficient at the PACU or on the ward patients will receive paracetamol 1gr IVParacetamol and ketorolac taradyal 30 mg IV Tramadol contramal 2 mgkg will be given as rescue analgesia On day one rescue analgesia will be provided orally
All rescue analgesia or other medication will be registered
48 hours after starting the pain pump the pump will be removed and all data will be collected and filed by an independent pain nurse or anaesthetist This file will consist of a detailed description of the history of local anaesthetic administered including total anaesthetic dose at 61224 and 48 hours frequency of extra boluses required and time intervals
Before removing the nerve catheter the depth of the catheter is checked and bolus of nacl will be infused under ultrasound guidance and if possible correct placement can be confirmed after two days Then the catheter will be removed
After stopping the pump the patient will be asked if he or she was satisfied by the postoperative analgesic technique
1 Satisfied
2 Sufficient
3 Not satisfied
The patient is discharged but is asked to register the exact time point when sensation and motor function when a motor block was present after catheter removal appeared The patient will be called two days after discharge to register these parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None