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

NCT03746418 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: tantaESB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

erector spinae; dexmedetomidine; ultrasound; lumbar interbody fusion; spondylolisthesis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Group I

PLACEBO COMPARATOR

received 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally.

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

Drug: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block

Interventions

Ultrasound Guided Bilateral single shot Erector Spinae Plane Block DRUG

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.

Group I; Group II

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead
• mona bologh elmorad,MD: collaborator
• mohmed naser shaddad,MD: collaborator

Study Sites (1)

Ahmed Said Elgebaly

Tanta, Egypt

Location

Related Publications (4)

• 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.

  PMID: 30166664 BACKGROUND

• 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.

  PMID: 29704223 RESULT

• 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.

  PMID: 29548343 RESULT

• 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.

  PMID: 29794943 RESULT

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: November 19, 2018
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: September 1, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

EG (1)