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

Double Level Lumbar Spondylolisthesis (L3-L5) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746418
• Other study ID #: tantaESB
• Status: Completed
• Phase: Early Phase 1
• Start date: January 1, 2016
• Est. completion date: September 1, 2018

Study information

• Verified date: November 2018
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 dexmedetomidine (Dex).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Double Level Lumbar Spondylolisthesis (L3-L5)
• Lumbar Fixation Surgery
• Posterior Lumbar Interbody Fusion (PLIF)
• Spondylolisthesis

Intervention

Drug:
• Ultrasound Guided Bilateral single shot Erector Spinae Plane Block
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.

Locations

Country	Name	City	State
Egypt	Ahmed Said Elgebaly	Tanta

Sponsors (3)

Lead Sponsor	Collaborator
Tanta University	mohmed naser shaddad,MD, mona bologh elmorad,MD

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 1hours, 6hours, 12hours, and 24 hours after the operation
Primary	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.	at 1hours, 6hours, 12hours, and 24 hours after the operation
Primary	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.	at 1hours, 6hours, 12hours, and 24 hours after the operation
Primary	changes in recovery time	assessment of changes in the recovery time length in (minutes) during the first 24 hours was reported.	at 1hours, 6hours, 12hours, and 24 hours after the operation