Clinical Trial Results:
Surgical anesthesia for elective hip surgery - hemodynamic effect of lumbosacral plexus blockade compared to continuous spinal anesthesia
Summary
|
|
EudraCT number |
2015-003498-13 |
Trial protocol |
DK |
Global end of trial date |
24 Feb 2017
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
09 May 2018
|
First version publication date |
09 May 2018
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
HIP/FUSION#1
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT02544269 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Local health research ethics committee no.: 51392, Danish data protection agency no.: 2015-57-0002 | ||
Sponsors
|
|||
Sponsor organisation name |
Institut for Klinisk Medicin
|
||
Sponsor organisation address |
Noerrebrogade 44, building 22, 1st floor, Aarhus C, Denmark, 8000
|
||
Public contact |
Niels Dalsgaard Nielsen, Institut for Klinisk Medicin, Aarhus Universitet, +45 2283 8334, nielsdn@dadlnet.dk
|
||
Scientific contact |
Niels Dalsgaard Nielsen, Institut for Klinisk Medicin, Aarhus Universitet, +45 2283 8334, nielsdn@dadlnet.dk
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
05 Apr 2017
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
24 Feb 2017
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
24 Feb 2017
|
||
Was the trial ended prematurely? |
Yes
|
||
General information about the trial
|
|||
Main objective of the trial |
Comparison of the hemodynamic effect of lumbosacral plexus blockade versus continuous spinal anesthesia.
|
||
Protection of trial subjects |
Continuous hemodynamic monitoring (electrocardiogram, pulseoxymetri, invasive arterial and central venous blood pressures, heart rate, cardiac output, cardiac stroke volume, systemic vascular resistance and central venous oxygen saturation) allowed for early detection of hemodynamic adverse events.
All skin punktures were preceded by subdermal infiltration with local anaesthetics (lidocaine 10 mg/mL).
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2016
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Denmark: 8
|
||
Worldwide total number of subjects |
8
|
||
EEA total number of subjects |
8
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
4
|
||
From 65 to 84 years |
4
|
||
85 years and over |
0
|
|
|||||||||||||||||||||
Recruitment
|
|||||||||||||||||||||
Recruitment details |
- | ||||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||||
Screening details |
Screened 24 patients. | ||||||||||||||||||||
Period 1
|
|||||||||||||||||||||
Period 1 title |
Pilot study (overall period)
|
||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Non-randomised - controlled
|
||||||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||||||
Blinding implementation details |
Subjects not blinded
|
||||||||||||||||||||
Arms
|
|||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||
Arm title
|
Lumbosacral plexus block | ||||||||||||||||||||
Arm description |
Surgical anaesthesia with lumbosacral plexus block by a combination of the following: Lumbar plexus block (Shamrock-block as described by A. Sauter) Sacral plexus block (Parasacral parallel shift-block as described by TF. Bendtsen) Iliohypogastric block (Fascia transversalis plane block as described by P. Hubbard) | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Ropivacaine
|
||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||
Other name |
|||||||||||||||||||||
Pharmaceutical forms |
Injection
|
||||||||||||||||||||
Routes of administration |
Perineural use
|
||||||||||||||||||||
Dosage and administration details |
Lumbar plexus block: 20 mL ropivacain 7,5 mg/mL perineural, single injection
Sacral plexus block: 10 mL ropivacain 7,5 mg/mL perineural, single injection
Iliohypogastric block: 10 mL ropivacain 7,5 mg/mL perineural, single injection
|
||||||||||||||||||||
Arm title
|
Continuous spinal anesthesia | ||||||||||||||||||||
Arm description |
Surgical anaesthesia with repeated intrathecal doses of bupivacain through a spinal catheter. | ||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||
Investigational medicinal product name |
Bupivacaine, CSA
|
||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||
Other name |
|||||||||||||||||||||
Pharmaceutical forms |
Injection
|
||||||||||||||||||||
Routes of administration |
Intrathecal use
|
||||||||||||||||||||
Dosage and administration details |
Repeated intrathecal doses of 0,5 mL bupivacaine 5 mg/mL. Dose repeated after 10 min and subsequent doses after 5 min if spinal anesthesia had not reached a level of the iliac crest. Max cumulated dose was 3 mL/15 mg.
|
||||||||||||||||||||
Arm title
|
Single-dose spinal anesthesia | ||||||||||||||||||||
Arm description |
Surgical anesthesia with a single intrathecal injection of bupivacaine | ||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||
Investigational medicinal product name |
Bupivacaine, SDSA
|
||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||
Other name |
|||||||||||||||||||||
Pharmaceutical forms |
Injection
|
||||||||||||||||||||
Routes of administration |
Intrathecal use
|
||||||||||||||||||||
Dosage and administration details |
Single intrathecal injection of 2 mL bupivacaine 5 mg/mL through a spinal catheter.
|
||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pilot study
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Lumbosacral plexus block
|
||
Reporting group description |
Surgical anaesthesia with lumbosacral plexus block by a combination of the following: Lumbar plexus block (Shamrock-block as described by A. Sauter) Sacral plexus block (Parasacral parallel shift-block as described by TF. Bendtsen) Iliohypogastric block (Fascia transversalis plane block as described by P. Hubbard) | ||
Reporting group title |
Continuous spinal anesthesia
|
||
Reporting group description |
Surgical anaesthesia with repeated intrathecal doses of bupivacain through a spinal catheter. | ||
Reporting group title |
Single-dose spinal anesthesia
|
||
Reporting group description |
Surgical anesthesia with a single intrathecal injection of bupivacaine |
|
|||||||||||||||||
End point title |
Change of cardiac output [1] | ||||||||||||||||
End point description |
Change of cardiac output (mL/min) from baseline (before nerve block performance) to 30 minutes after nerve block.
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
30 minutes after nerve block performance
|
||||||||||||||||
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As the trial was haltet after the pilot study only data from 6 patients in 3 groups was collected. It was not deemed meaningful to analyse on these sparse numbers. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Time for nerve blockade performance [2] | ||||||||
End point description |
Duration of lumbar plexus block (LPB) and sacral plexus block (SPB) performance from beginning of ultrasound scan (after applying sterile dressing) before LPB to withdrawal of nerve block needle after SPB.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
After nerve block performance
|
||||||||
Notes [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As the trial was haltet after the pilot study only data from 6 patients in 3 groups was collected. It was not deemed meaningful to analyse on these sparse numbers. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Success rate of surgical anesthesia | ||||||||||||
End point description |
Rate (0-1) of success of surgical anesthesia.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At time of positioning of patient on operating table
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Cumulated peroperative dose of propofol | ||||||||||||||||
End point description |
Cummulated dose of intravenous propofol administered during surgery
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
As patient leaves the operating room
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Cumulated peroperative dose of opioids | ||||||||||||||||
End point description |
Cumulated dose of intravenous opioids administered during surgery. Converted to peroral morphine equivalents.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
As patient leaves the operating room
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Cumulated postoperative does of opioids | ||||||||||||||||
End point description |
Cumulated dose of opioid administered during the first 24 hours after surgery. Converted to peroral morphine equivalents.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
24 hours after surgery
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Time to first opioid dose | ||||||||||||||||
End point description |
Time from end of surgery to first request for opioids.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
24 hours after surgery.
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change of cardiac stroke volume | ||||||||||||||||
End point description |
Change of cardiac stroke volume (mL) from baseline (before nerve block performance) to 30 minutes after nerve block.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
30 minutes after nerve block performance
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change of systemic vascular resistance | ||||||||||||||||
End point description |
Change of systemic vascular resistance (dyne-s/cm⁵) from baseline (before nerve block performance) to 30 minutes after nerve block.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
30 minutes after nerve block performance
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change of mean arterial pressure | ||||||||||||||||
End point description |
Change of mean arterial blood pressure (mm Hg) from baseline (before nerve block performance) to 30 minutes after nerve block.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
30 minutes after nerve block performance
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change of central venous oxygen saturation | ||||||||||||||||
End point description |
Change of central venous oxygen saturation (%) from baseline (before nerve block performance) to 30 minutes after nerve block.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
30 minutes after nerve block performance
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Pilot study
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Lumbosacral plexus block
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Surgical anaesthesia with lumbosacral plexus block by a combination of the following: Lumbar plexus block (Shamrock-block as described by A. Sauter) Sacral plexus block (Parasacral parallel shift-block as described by TF. Bendtsen) Iliohypogastric block (Fascia transversalis plane block as described by P. Hubbard) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Continuous spinal anesthesia
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Surgical anaesthesia with repeated intrathecal doses of bupivacain through a spinal catheter. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Single-dose spinal anesthesia
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Surgical anesthesia with a single intrathecal injection of bupivacaine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: No it's not. 3 subjects was exposed in the lumbosacral plexus block-group, 2 subjects was exposed in the continuous spinal anesthesia-group and 1 subject was exposed in the single-dose spinal anesthesia-group. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: No it's not. 3 subjects was exposed in the lumbosacral plexus block-group, 2 subjects was exposed in the continuous spinal anesthesia-group and 1 subject was exposed in the single-dose spinal anesthesia-group. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: No it's not. 3 subjects was exposed in the lumbosacral plexus block-group, 2 subjects was exposed in the continuous spinal anesthesia-group and 1 subject was exposed in the single-dose spinal anesthesia-group. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: No it's not. 3 subjects was exposed in the lumbosacral plexus block-group, 2 subjects was exposed in the continuous spinal anesthesia-group and 1 subject was exposed in the single-dose spinal anesthesia-group. |
|
|||||||
Substantial protocol amendments (globally) |
|||||||
Were there any global substantial amendments to the protocol? No | |||||||
Interruptions (globally) |
|||||||
Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
Results are from a non-randomised non-blinded pilot study. |