Erector Spine Block for Back Surgery
Primary Purpose
Spine Disease, Regional Anaesthesia
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
erector spinae block
Ropivacaine
Spine surgery
anesthesia
Sponsored by
About this trial
This is an interventional other trial for Spine Disease focused on measuring spine surgery, regional anaesthesia, opioid consumption, acute postoperative pain
Eligibility Criteria
Inclusion Criteria:
- Patients planned for laminectomy or back surgery with lumbar pedicle screw placement or revision back surgery
Exclusion Criteria:
- patient refusal, bleeding disorder, infection
Sites / Locations
- AZ KLina
- University Hospital Antwerp
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
erector spinae block
Arm Description
bilateral erector spine block with 20 ml 0,375% ropivacaine
Outcomes
Primary Outcome Measures
24 hour opioid consumption
cumulative opioid consumption first 24 hours after block performance
Secondary Outcome Measures
sensory block
loss of cold sensation of anterior and posterior roots of lumbar spinal nerve dermatomes
motor block
motor function of legs by Bromage scale
pain scores
numeric rating scores postoperative pain ( 0-10)
Full Information
NCT ID
NCT03214536
First Posted
July 5, 2017
Last Updated
November 13, 2018
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT03214536
Brief Title
Erector Spine Block for Back Surgery
Official Title
Erector Spine Block in Patients Undergoing Back Surgery, Observational Feasibility Trial of the Effect on Postoperative Pain-scores and Opioid Consumption
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 25, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In spine surgery postoperative pain can often be severe and difficult to treat.With the use of ultrasound, the performance of plane blocks and other techniques like root blocks, facet infiltration have become possible without the use of either unreliable " pop-techniques" or the use of x-ray.The erector spinae block was recently described as a safe and simple and safe technique for neuropathic pain and acute post surgical pain, with effect on the dorsal rami of the spinal nerves and with promising results. In this observational pilot study we want to test the influence of these to blocks on the postoperative pain and opioid consumption after spine fusion.
Detailed Description
In 10-15 patients undergoing back surgery (laminectomy or back surgery with lumbar pedicle screw placement or revision back surgery), will be asked to give informed consent to receive a bilateral lumbar erector spinae block before surgery. In this population it will be clear after 10-15 patients if there is a beneficial effect since these patients normally require a substantial amount of postoperative opioids because of significant postoperative pain.
The blocks will be performed by experts in the field of ultrasound guided locoregional anaesthesia in a separate block room with ultrasound after placement of an iv line and application of standard monitoring (ECG, NIBP, saturation)
Description of block performance according to Chinn et al but at a lumbar level:
The patient will be placed in the lateral or sitting position. With a curve array probe or a high frequency linear probe, depending on the BMI of the patient, will be placed in a longitudinal position 2-3 cm lateral of the vertebral column. The transverse processes of the vertebrae at the (mid) level of surgery, the erector spinae muscle and the psoas muscle are identified. Depending on the depth a 5 or 8 cm 22 G ultrasound needle (pajunk) will be inserted in an in plane technique in a cephalad to caudad direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, 20 ml of ropivacaine 0,375% will be injected behind the erector spinae muscle. The same procedure will be repeated on the contralateral side.
Sensory loss of the posterior dermatomes and dermatomes of the anterior roots of the spinal nerves (lumbar plexus, upper leg) will be tested Motor function of the legs will be evaluated with a Bromage (0-3) score.
General anaesthesia will then be induced in a standardized way with propofol, sufentanyl and rocuronium. The maintenance of anaesthesia and the procedure will be performed according to protocol.
After surgery analgesia will be provided with nsaid when applicable and 1000 mg paracetamol IV 4 times daily combined with a PCA (patient controlled analgesia) pump depending on the site:
AZ klina protocol: PCA piritramide/dhbp pump: 0ml/h, 2 mg bolus, 20 minutes lockout
UZA protocol: Morphine/dhbp pump: 0ml/h 1 mg bolus, 8minutes lock out) and Pain scores (NRS, 0=no pain 10= worst pain ever), will be tested on the post anesthesia care unit every hour and according to hospital postoperative protocol at the ward during the fist 24 hours.
The amount and frequency of the opioid usage of the first 24 hours will be extracted out of the PCA pump. In patients without a block, opioid consumption is mostly expected between 25-40 mg morphine/24h (loading dose excluded) according to weight. We expect to see a substantial decrease (at least 50 %) in opioid consumption.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Disease, Regional Anaesthesia
Keywords
spine surgery, regional anaesthesia, opioid consumption, acute postoperative pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
observational feasibility trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
erector spinae block
Arm Type
Experimental
Arm Description
bilateral erector spine block with 20 ml 0,375% ropivacaine
Intervention Type
Procedure
Intervention Name(s)
erector spinae block
Intervention Description
bilateral injection of local anaesthetic between the erector spinae muscle and the transverse process
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
naropin
Intervention Description
injection of 20 ml ropivacaine 0.375 % bilateral by erector spinae block
Intervention Type
Procedure
Intervention Name(s)
Spine surgery
Intervention Description
Surgery of lumbar spine
Intervention Type
Procedure
Intervention Name(s)
anesthesia
Intervention Description
general anesthesia
Primary Outcome Measure Information:
Title
24 hour opioid consumption
Description
cumulative opioid consumption first 24 hours after block performance
Time Frame
24 hours from injection ( T0)
Secondary Outcome Measure Information:
Title
sensory block
Description
loss of cold sensation of anterior and posterior roots of lumbar spinal nerve dermatomes
Time Frame
30 minutes after block performance
Title
motor block
Description
motor function of legs by Bromage scale
Time Frame
30 minutes after block performance
Title
pain scores
Description
numeric rating scores postoperative pain ( 0-10)
Time Frame
24 postoperative at regular intervals
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients planned for laminectomy or back surgery with lumbar pedicle screw placement or revision back surgery
Exclusion Criteria:
patient refusal, bleeding disorder, infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
margaretha breebaart, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ KLina
City
Brasschaat
State/Province
Antwerp
Country
Belgium
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Erector Spine Block for Back Surgery
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