Comparing the Effect of Adding Dexmedetomidine to Bupivacaine in Classical and Modified Thoracolumbar Interfascial Plane Block on Postoperative Pain in Patients Undergoing Lumbar Disc Surgeries

NCT06690021 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Dexmedetomidine TLIP lumbar
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Spinal surgeries are frequently conducted to stabilize the vertebrae and discs of the spine. These surgeries typically require substantial manipulation of subcutaneous tissues, bones, and ligaments . Postoperative pain relates to mechanical irritation, compression, and postoperative inflammation. The uncontrolled pain could promote the development of chronic persistent pain and worsen independence, mood, and quality of life. Effective pain management facilitates early mobilisation and accelerates hospital discharge. this study aim to investigate the effectiveness of a mixture of dexmedetomidine and bupivacaine in classical thoracolumbar interfascial plane block compare to modified thoracolumbar interfascial plane block on postoperative pain in patients undergoing lumbar disc surgeries.

Conditions

Lumbar Disc Surgery

Keywords

Dexmedetomidine; Classical and Modified Thoracolumbar Interfascial Plane Block

Outcome Measures

Primary Outcomes (1)

• total opioid consumption

  To assess the total perioperative (intraoperative and 24 h postoperative) opioid consumption in the first 24 h.

  24 hours

Secondary Outcomes (1)

• post operative VAS score

  24 hours

Study Arms (2)

group 1

EXPERIMENTAL

Classical Thoracolumbar Interfascial Plane Block

Drug: Dexmedetomidine

group 2

EXPERIMENTAL

Modified Thoracolumbar Interfascial Plane Block

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Thoracolumbar Interfascial Plane Block using Bupivacaine and dexmedetomidine

group 1; group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years old
• Both sex
• Patients who were in risk-scoring groups I-II of the American Society of Anesthesiologists (ASA)

You may not qualify if:

• Patient refusal.
• coagulation disorders that affect the blood's clotting activities e.g.: Hemophilia.
• skin lesions or infection at site of proposed needle.
• known allergy to local anesthetics or dexmedetomidine.
• patients suffering from mental disease as cannot Assess the Visual Analogue Scale (VAS) that measures pain intensity as, mental retardation \& psychosis

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Ammar MA, Taeimah M. Evaluation of thoracolumbar interfascial plane block for postoperative analgesia after herniated lumbar disc surgery: A randomized clinical trial. Saudi J Anaesth. 2018 Oct-Dec;12(4):559-564. doi: 10.4103/sja.SJA_177_18.

  PMID: 30429737 BACKGROUND

• Sarvesh B, Shivaramu BT, Sharma K, Agarwal A. Addition of Dexmedetomidine to Ropivacaine in Subcostal Transversus Abdominis Plane Block Potentiates Postoperative Analgesia among Laparoscopic Cholecystectomy Patients: A Prospective Randomized Controlled Trial. Anesth Essays Res. 2018 Oct-Dec;12(4):809-813. doi: 10.4103/aer.AER_141_18.

  PMID: 30662112 BACKGROUND

• Nasr DA, Abdelhamid HM. The efficacy of caudal dexmedetomidine on stress response and postoperative pain in pediatric cardiac surgery. Ann Card Anaesth. 2013 Apr-Jun;16(2):109-14. doi: 10.4103/0971-9784.109744.

  PMID: 23545865 BACKGROUND

• Tantri AR, Sukmono RB, Lumban Tobing SDA, Natali C. Comparing the Effect of Classical and Modified Thoracolumbar Interfascial Plane Block on Postoperative Pain and IL-6 Level in Posterior Lumbar Decompression and Stabilization Surgery. Anesth Pain Med. 2022 Apr 12;12(2):e122174. doi: 10.5812/aapm-122174. eCollection 2022 Apr.

  PMID: 36061531 BACKGROUND

• Mondal S, Pandey RK, Kumar M, Sharma A, Darlong V, Punj J. Analgesic efficacy of classical thoracolumbar interfascial plane block versus modified thoracolumbar interfascial plane block in patients undergoing lumbar disc surgeries: A comparative, randomised controlled trial. Indian J Anaesth. 2024 Apr;68(4):366-373. doi: 10.4103/ija.ija_1153_23. Epub 2024 Mar 13.

  PMID: 38586260 BACKGROUND

• Khan MA, Gupta M, Sharma S, Kasaudhan S. A comparative study of ultrasound assisted versus landmark technique for combined spinal-epidural anaesthesia in patients undergoing lower limb orthopaedic surgery. Indian J Anaesth. 2022 Apr;66(4):272-277. doi: 10.4103/ija.ija_775_21. Epub 2022 Apr 20.

  PMID: 35663223 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mohand Mohamed Fathy Salem

CONTACT

+2 01121482878; Mohanad.16266396@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent anesthesiologist randomly using computer-generated random numbers divided the patients into 2 groups :(Group 1 and Group 2). Each group will include 15 patients. We discreetly placed the randomization results in envelopes until the end of the study. The researchers who were responsible for postoperative follow-up and data processing were blinded to the group allocation during the whole study period. All patients were also blinded to the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor anesthesia, Intensive Care and Pain Management

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-11