Effect of Addition of Dexmedetomidine During Ultrasound Guided Bilateral Single Shot Erector Spinae Plane Block in Patients Undergoing Posterior Lumbar Interbody Fusion Under General Anesthesia
Primary Purpose
Double Level Lumbar Spondylolisthesis (L3-L5), Posterior Lumbar Interbody Fusion (PLIF), Lumbar Fixation Surgery
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound Guided Bilateral single shot Erector Spinae Plane Block
Sponsored by
About this trial
This is an interventional prevention trial for Double Level Lumbar Spondylolisthesis (L3-L5) focused on measuring erector spinae, dexmedetomidine, ultrasound, lumbar interbody fusion, spondylolisthesis
Eligibility Criteria
Inclusion Criteria:
- belonged to the American Society of Anesthesiologists (ASA) physical status I or II
- either sex
- aged 18-60 years
- body mass index less 35 kg/m2
- complaining from double level lumbar spondylolisthesis (L3-L5)
- scheduled for elective surgical intervention aimed at lumbar spine fixation by PLIF - under general anesthesia.
Exclusion Criteria:
- obesity (body mass index > 35 kg/m2)
- infection of the skin at the site of the needle puncture
- allergies to either of the study drugs
- bleeding disorder
- and recent use of opioid.
Sites / Locations
- Ahmed Said Elgebaly
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Group I
Group II
Arm Description
received 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally.
received 20 ml of 0.25% bupivacaine with supplementation of 1 mL containing 100µg dexmedetomidine bilaterally
Outcomes
Primary Outcome Measures
changes in Post-Anesthesia Care Unit (PACU) length of stay
assessment of changes in the Post-Anesthesia Care Unit (PACU) length of stay in (minutes) during the first 24 hours was reported.
changes in the total dose of postoperative analgesics need
assessment of changes in the total dose of postoperative analgesics need in the first 24 hours were reported.
changes in postoperative visual analogue score (VAS)
assessment of changes in the postoperative visual analogue score (VAS)in the first 24 hours was reported.
Scoring and Interpretation: Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Based on the distribution of pain VAS scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) . Normative values are not available. The scale has to be shown to the patient otherwise it is an auditory scale, not a visual one.
changes in recovery time
assessment of changes in the recovery time length in (minutes) during the first 24 hours was reported.
Secondary Outcome Measures
Full Information
NCT ID
NCT03746418
First Posted
November 11, 2018
Last Updated
November 17, 2018
Sponsor
Tanta University
Collaborators
mona bologh elmorad,MD, mohmed naser shaddad,MD
1. Study Identification
Unique Protocol Identification Number
NCT03746418
Brief Title
Effect of Addition of Dexmedetomidine During Ultrasound Guided Bilateral Single Shot Erector Spinae Plane Block in Patients Undergoing Posterior Lumbar Interbody Fusion Under General Anesthesia
Official Title
Effect of Addition of Dexmedetomidine During Ultrasound Guided Bilateral Single Shot Erector Spinae Plane Block in Patients Undergoing Posterior Lumbar Interbody Fusion Under General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
Collaborators
mona bologh elmorad,MD, mohmed naser shaddad,MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Posterior lumbar interbody fusion (PLIF) is the management of choice in double level lumbar (L) spondylolisthesis (L3-L5) after ineffective conservative treatment. We evaluated bilateral ultrasound (US)-guided single shot erector spinae plane (ESP) block at the level of lumbar 3 (L3) vertebra with or without dexmedetomidine (Dex).
Detailed Description
Objectives: Posterior lumbar interbody fusion (PLIF) is the management of choice in double level lumbar (L) spondylolisthesis (L3-L5) after ineffective conservative treatment. We evaluated bilateral ultrasound (US)-guided single shot erector spinae plane (ESP) block at the level of lumbar 3 (L3) vertebra with or without dexmedetomidine (Dex).
Methods: A prospective controlled randomized, double-blind study comparing two groups of patients; each group included 20 patients of double level spondylolisthesis (L3-L5) scheduled for (PLIF) under general anesthesia combined with bilateral US-guided ESP single shot block at (L3). Group I received 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally. Group II received 20 ml of 0.25% bupivacaine with supplementation of 1 mL containing 100µg dexmedetomidine bilaterally. Post-Anesthesia Care Unit (PACU) length of stay, the total dose of postoperative analgesics need, postoperative visual analogue score (VAS) at 1h, 6h, 12h, and 24 h after the operation and postoperative complications which related to block or opioids were recorded.
ESP block at combined with (Dex) is a safe, effective block with no complications. Addition of 100µg Dex to preoperative ESP block provided good postoperative opioid-sparing analgesia, facilitated the early emergence and shortened the length of stay in the PACU during (PLIF) for double level spondylolisthesis (L3-L5).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Double Level Lumbar Spondylolisthesis (L3-L5), Posterior Lumbar Interbody Fusion (PLIF), Lumbar Fixation Surgery
Keywords
erector spinae, dexmedetomidine, ultrasound, lumbar interbody fusion, spondylolisthesis
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Placebo Comparator
Arm Description
received 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
received 20 ml of 0.25% bupivacaine with supplementation of 1 mL containing 100µg dexmedetomidine bilaterally
Intervention Type
Drug
Intervention Name(s)
Ultrasound Guided Bilateral single shot Erector Spinae Plane Block
Intervention Description
Under aseptic technique and after skin infiltration with 3 ml of 2% lidocaine, a 22G, 50-mm, insulated facet type needle (visioplex® - vygon - France) was introduced in plane in a cephalad to caudad direction until (L3) transverse process was hit [figure1(A)(B)(C)] and the needle was slightly withdrawn. The confirmation of the correct position of the needle tip was done by injecting 0.5-1 ml of LA. Once confirmed, 20 ml of the drug was administered under vision after confirming negative aspiration of blood. LA distribution was observed in both cranial and caudal directions. This was repeated on the other side also. Twenty minutes later, sensory loss to cold was evident between (T10-T 12) and (L5-S1) vertebral level of the posterior dermatomes and dermatomes of the anterior roots of the spinal nerves (lumbar plexus, upper leg) on both sides without hemodynamic changes. Motor function of the legs was evaluated with a Bromage (0-3) score.
Primary Outcome Measure Information:
Title
changes in Post-Anesthesia Care Unit (PACU) length of stay
Description
assessment of changes in the Post-Anesthesia Care Unit (PACU) length of stay in (minutes) during the first 24 hours was reported.
Time Frame
at 1hours, 6hours, 12hours, and 24 hours after the operation
Title
changes in the total dose of postoperative analgesics need
Description
assessment of changes in the total dose of postoperative analgesics need in the first 24 hours were reported.
Time Frame
at 1hours, 6hours, 12hours, and 24 hours after the operation
Title
changes in postoperative visual analogue score (VAS)
Description
assessment of changes in the postoperative visual analogue score (VAS)in the first 24 hours was reported.
Scoring and Interpretation: Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Based on the distribution of pain VAS scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) . Normative values are not available. The scale has to be shown to the patient otherwise it is an auditory scale, not a visual one.
Time Frame
at 1hours, 6hours, 12hours, and 24 hours after the operation
Title
changes in recovery time
Description
assessment of changes in the recovery time length in (minutes) during the first 24 hours was reported.
Time Frame
at 1hours, 6hours, 12hours, and 24 hours after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
belonged to the American Society of Anesthesiologists (ASA) physical status I or II
either sex
aged 18-60 years
body mass index less 35 kg/m2
complaining from double level lumbar spondylolisthesis (L3-L5)
scheduled for elective surgical intervention aimed at lumbar spine fixation by PLIF - under general anesthesia.
Exclusion Criteria:
obesity (body mass index > 35 kg/m2)
infection of the skin at the site of the needle puncture
allergies to either of the study drugs
bleeding disorder
and recent use of opioid.
Facility Information:
Facility Name
Ahmed Said Elgebaly
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30166664
Citation
Chaudhary NK, Singh S. Continuous ultrasound-guidederector spinae plane block for post-operative pain management in lumbar spine surgery: A case series. Indian J Anaesth. 2018 Aug;62(8):638-639. doi: 10.4103/ija.IJA_160_18. No abstract available.
Results Reference
background
PubMed Identifier
29704223
Citation
Melvin JP, Schrot RJ, Chu GM, Chin KJ. Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series. Can J Anaesth. 2018 Sep;65(9):1057-1065. doi: 10.1007/s12630-018-1145-8. Epub 2018 Apr 27.
Results Reference
result
PubMed Identifier
29548343
Citation
Zhang S, Ye C, Lai Q, Yu X, Liu X, Nie T, Zhan H, Dai M, Zhang B. Double-level lumbar spondylolysis and spondylolisthesis: A retrospective study. J Orthop Surg Res. 2018 Mar 16;13(1):55. doi: 10.1186/s13018-018-0723-3.
Results Reference
result
PubMed Identifier
29794943
Citation
Adhikary SD, Bernard S, Lopez H, Chin KJ. Erector Spinae Plane Block Versus Retrolaminar Block: A Magnetic Resonance Imaging and Anatomical Study. Reg Anesth Pain Med. 2018 Oct;43(7):756-762. doi: 10.1097/AAP.0000000000000798.
Results Reference
result
Learn more about this trial
Effect of Addition of Dexmedetomidine During Ultrasound Guided Bilateral Single Shot Erector Spinae Plane Block in Patients Undergoing Posterior Lumbar Interbody Fusion Under General Anesthesia
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