Double Level Lumbar Spondylolisthesis (L3-L5)Early Phase 1NCT03746418

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

A Early Phase 1 study testing Ultrasound Guided Bilateral single shot Erector Spinae Plane Block in people with Double Level Lumbar Spondylolisthesis (L3-L5) and Posterior Lumbar Interbody Fusion (PLIF), run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Double Level Lumbar Spondylolisthesis (L3-L5), Posterior Lumbar Interbody Fusion (PLIF), Lumbar Fixation Surgery
What is being tested?: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteEgypt
Study dates: 1 Jan 2016to 1 Sep 2018
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Ahmed Said Elgebaly
Tanta

Other trials in Egypt

About this study

Read the 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).

Conditions: Double Level Lumbar Spondylolisthesis (L3-L5), Posterior Lumbar Interbody Fusion (PLIF), Lumbar Fixation Surgery
Being tested: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block
Keywords: erector spinae, dexmedetomidine, ultrasound, lumbar interbody fusion, spondylolisthesis
Medical subject headings: Spondylolisthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ultrasound Guided Bilateral single shot Erector Spinae Plane BlockDrug
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.

Study groups in NCT03746418
Study group	Role	What they receive
Group I	Placebo comparator	received 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally. Receives: Drug: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block
Group II	Active comparator	received 20 ml of 0.25% bupivacaine with supplementation of 1 mL containing 100µg dexmedetomidine bilaterally Receives: Drug: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: at 1hours, 6hours, 12hours, and 24 hours after the operation
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.
Measured: at 1hours, 6hours, 12hours, and 24 hours after the operation
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.
Measured: at 1hours, 6hours, 12hours, and 24 hours after the operation
changes in recovery time
assessment of changes in the recovery time length in (minutes) during the first 24 hours was reported.
Measured: at 1hours, 6hours, 12hours, and 24 hours after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20161 Sep 2018

First posted19 Nov 2018
Study start1 Jan 2016
Primary completion1 Jan 2018
Study completion1 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Double Level Lumbar Spondylolisthesis (L3-L5)Studies of the same condition, open and under way.
More trials run by Tanta UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03746418
Sponsor's protocol ID: tantaESB
Status last verified: Nov 2018
First submitted: 11 Nov 2018
Last updated: 20 Nov 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 30166664
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.
PubMed 29704223
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.
PubMed 29548343
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.
PubMed 29794943

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03746418
Acronym / sponsor ID: tantaESB
Conditions: Double Level Lumbar Spondylolisthesis (L3-L5), Posterior Lumbar Interbody Fusion (PLIF), Lumbar Fixation Surgery
Keywords: erector spinae, dexmedetomidine, ultrasound, lumbar interbody fusion, spondylolisthesis
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Tanta UniversityUniversity, hospital or other
Collaborators: mona bologh elmorad,MD, mohmed naser shaddad,MD
Study start: 1 Jan 2016 (actual)
Primary completion: 1 Jan 2018 (actual)
Study completion: 1 Sep 2018 (actual)
First posted: 19 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group I	Placebo comparator	Drug: Ultrasound Guided Bilateral single shot Erector Spinae Plane Blockreceived 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally.
Group II	Active comparator	Drug: Ultrasound Guided Bilateral single shot Erector Spinae Plane Blockreceived 20 ml of 0.25% bupivacaine with supplementation of 1 mL containing 100µg dexmedetomidine bilaterally

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ultrasound Guided Bilateral single shot Erector Spinae Plane BlockUnder 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.	Drug	Group I, Group II

Primary outcome

changes in Post-Anesthesia Care Unit (PACU) length of stay
Time frame: at 1hours, 6hours, 12hours, and 24 hours after the operation
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
Time frame: at 1hours, 6hours, 12hours, and 24 hours after the operation
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)
Time frame: at 1hours, 6hours, 12hours, and 24 hours after the operation
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
Time frame: at 1hours, 6hours, 12hours, and 24 hours after the operation
assessment of changes in the recovery time length in (minutes) during the first 24 hours was reported.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
Background: PubMed 30166664Chaudhary 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 publication: PubMed 29704223Melvin 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 publication: PubMed 29548343Zhang 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 publication: PubMed 29794943Adhikary 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.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes in Post-Anesthesia Care Unit (PACU) length of stay (time frame: at 1hours, 6hours, 12hours, and 24 hours after the operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03746418, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.