RCT - Epidural Anesthetic Cocktail Following Endoscopic Lumbar Discectomy

NCT05738759 | Recruiting DMC

• 1 other identifier: 013/2565
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to study the effect of intraoperative epidural application of anesthetic cocktail following endoscopic lumbar discectomy in improving postoperative pain, length of hospital stay, time at first dose analgesia, post-operative opioid consumption, functional outcomes, time return to work, and postoperative complications

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI)

  To compare efficacy of patient-reported functional outcomes achieved with epidural cocktail, measured as Oswestry Disability Index (ODI) at 3 months

  3rd month

Secondary Outcomes (2)

• Functional Outcomes

  POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr

• Postoperative outcomes

  POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr

Study Arms (2)

Epidural Anesthetic Cocktail

EXPERIMENTAL

Patients which received epidural anesthetic cocktail following endoscopic discectomy

Drug: Epidural Anesthetic Cocktail

Placebo

PLACEBO COMPARATOR

Patients which received placebo following endoscopic discectomy

Drug: Placebo

Interventions

Epidural Anesthetic Cocktail DRUG

The anesthetic cocktail, consists of triamcinolone 40 mg, marcaine 5 mg, and morphine 3 mg, is soaked in the gelfoam size 1x2 cm and applied on the epidura before removal of the endoscope.

Also known as: Cocktail

Epidural Anesthetic Cocktail

Placebo DRUG

The placebo is soaked with NSS in the gelfoam size 1x2 cm as well and applied on the epidura before removal of the endoscope.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60
• Lumbar radiculopathy
• No prior spinal surgery or recurrent lumbar disc herniation
• Plan for endoscopic discectomy after failed conservative for at least 6 weeks
• Single-level herniation confirmed by MRI which correlated with symptoms

You may not qualify if:

• Allergic or contraindicated to amide-type anesthesia, opioid, NSAIDs, or steroids
• Cauda equina syndrome
• Concomitant with other abnormalities
• Unable to answer questionnaires
• Cannot tolerate surgery due to medical comorbidities

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Queen Savang Vadhana Memorial Hospital

Chon Buri, 20110, Thailand

RECRUITING

Related Publications (21)

• Jordan J, Konstantinou K, O'Dowd J. Herniated lumbar disc. BMJ Clin Evid. 2009 Mar 26;2009:1118.

  PMID: 19445754 BACKGROUND

• Wilder DG, Pope MH, Frymoyer JW. The biomechanics of lumbar disc herniation and the effect of overload and instability. J Spinal Disord. 1988;1(1):16-32.

  PMID: 2980059 BACKGROUND

• Bajwa SJ, Haldar R. Pain management following spinal surgeries: An appraisal of the available options. J Craniovertebr Junction Spine. 2015 Jul-Sep;6(3):105-10. doi: 10.4103/0974-8237.161589.

  PMID: 26288544 BACKGROUND

• Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg. 2002 Mar-Apr;10(2):117-29. doi: 10.5435/00124635-200203000-00007.

  PMID: 11929206 BACKGROUND

• Elder JB, Hoh DJ, Wang MY. Postoperative continuous paravertebral anesthetic infusion for pain control in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2008 Jan 15;33(2):210-8. doi: 10.1097/BRS.0b013e318160447a.

  PMID: 18197109 BACKGROUND

• Jirarattanaphochai K, Jung S, Thienthong S, Krisanaprakornkit W, Sumananont C. Peridural methylprednisolone and wound infiltration with bupivacaine for postoperative pain control after posterior lumbar spine surgery: a randomized double-blinded placebo-controlled trial. Spine (Phila Pa 1976). 2007 Mar 15;32(6):609-16; discussion 617. doi: 10.1097/01.brs.0000257541.91728.a1.

  PMID: 17413463 BACKGROUND

• Mirzai H, Tekin I, Alincak H. Perioperative use of corticosteroid and bupivacaine combination in lumbar disc surgery: a randomized controlled trial. Spine (Phila Pa 1976). 2002 Feb 15;27(4):343-6. doi: 10.1097/00007632-200202150-00003.

  PMID: 11840097 BACKGROUND

• Du JP, Fan Y, Hao DJ, Huang YF, Zhang JN, Yuan LH. Application of Gelatin Sponge Impregnated with a Mixture of 3 Drugs to Intraoperative Nerve Root Block to Promote Early Postoperative Recovery of Lumbar Disc Herniation. World Neurosurg. 2018 Jun;114:e1168-e1173. doi: 10.1016/j.wneu.2018.03.170. Epub 2018 Mar 31.

  PMID: 29614356 BACKGROUND

• Keorochana G, Pairuchvej S, Setrkraising K, Arirachakaran A, Kongtharvonskul J. Comparative Outcomes of Perioperative Epidural Steroids After Percutaneous Endoscopic Lumbar Discectomy for Lumbar Disc Herniation: A Randomized Placebo-Controlled Trial. World Neurosurg. 2018 Nov;119:e244-e249. doi: 10.1016/j.wneu.2018.07.122. Epub 2018 Jul 27.

  PMID: 30059778 BACKGROUND

• Kjaergaard M, Moiniche S, Olsen KS. Wound infiltration with local anesthetics for post-operative pain relief in lumbar spine surgery: a systematic review. Acta Anaesthesiol Scand. 2012 Mar;56(3):282-90. doi: 10.1111/j.1399-6576.2011.02629.x. Epub 2012 Jan 19.

  PMID: 22260370 BACKGROUND

• Li K, Ji C, Luo D, Feng H, Yang K, Xu H. Wound infiltration with ropivacaine as an adjuvant to patient controlled analgesia for transforaminal lumbar interbody fusion: a retrospective study. BMC Anesthesiol. 2020 Nov 18;20(1):288. doi: 10.1186/s12871-020-01205-5.

  PMID: 33208089 BACKGROUND

• Steel T, Jones R, Crossman J, Sheehy J, Bentivoglio P, Pell M. Intraoperative wound infiltration with bupivacaine in patients undergoing lumbar spine surgery. J Clin Neurosci. 1998 Jul;5(3):298-303. doi: 10.1016/s0967-5868(98)90065-0.

  PMID: 18639036 BACKGROUND

• Ersayli DT, Gurbet A, Bekar A, Uckunkaya N, Bilgin H. Effects of perioperatively administered bupivacaine and bupivacaine-methylprednisolone on pain after lumbar discectomy. Spine (Phila Pa 1976). 2006 Sep 1;31(19):2221-6. doi: 10.1097/01.brs.0000232801.19965.a0.

  PMID: 16946657 BACKGROUND

• Arirachakaran A, Siripaiboonkij M, Pairuchvej S, Setrkraising K, Pruttikul P, Piyasakulkaew C, Kongtharvonskul J. Comparative outcomes of epidural steroids versus placebo after lumbar discectomy in lumbar disc herniation: a systematic review and meta-analysis of randomized controlled trials. Eur J Orthop Surg Traumatol. 2018 Dec;28(8):1589-1599. doi: 10.1007/s00590-018-2229-4. Epub 2018 May 29.

  PMID: 29845327 BACKGROUND

• Jamjoom BA, Jamjoom AB. Efficacy of intraoperative epidural steroids in lumbar discectomy: a systematic review. BMC Musculoskelet Disord. 2014 May 5;15:146. doi: 10.1186/1471-2474-15-146.

  PMID: 24885519 BACKGROUND

• Wilson-Smith A, Chang N, Lu VM, Mobbs RJ, Fadhil M, Lloyd D, Kim S, Phan K. Epidural Steroids at Closure After Microdiscectomy/Laminectomy for Reduction of Postoperative Analgesia: Systematic Review and Meta-Analysis. World Neurosurg. 2018 Feb;110:e212-e221. doi: 10.1016/j.wneu.2017.10.133. Epub 2017 Nov 1.

  PMID: 29102751 BACKGROUND

• Akinduro OO, Miller BA, Haussen DC, Pradilla G, Ahmad FU. Complications of intraoperative epidural steroid use in lumbar discectomy: a systematic review and meta-analysis. Neurosurg Focus. 2015 Oct;39(4):E12. doi: 10.3171/2015.7.FOCUS15269.

  PMID: 26424336 BACKGROUND

• McNeill TW, Andersson GB, Schell B, Sinkora G, Nelson J, Lavender SA. Epidural administration of methylprednisolone and morphine for pain after a spinal operation. A randomized, prospective, comparative study. J Bone Joint Surg Am. 1995 Dec;77(12):1814-8. doi: 10.2106/00004623-199512000-00004.

  PMID: 8550648 BACKGROUND

• Bahari S, El-Dahab M, Cleary M, Sparkes J. Efficacy of triamcinolone acetonide and bupivacaine for pain after lumbar discectomy. Eur Spine J. 2010 Jul;19(7):1099-103. doi: 10.1007/s00586-010-1360-7. Epub 2010 Mar 12.

  PMID: 20224868 BACKGROUND

• Samoladas E, Kapinas A, Papadopoulos DV, Gkiatas I, Papastefanou S, Gelalis ID. Intraoperative epidural application of steroid and local anaesthetic agent following lumbar discectomy: A prospective double blinded randomized controlled trial. J Clin Orthop Trauma. 2019 Oct;10(Suppl 1):S143-S146. doi: 10.1016/j.jcot.2019.03.005. Epub 2019 Mar 12.

  PMID: 31695273 BACKGROUND

• Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J. 2008 Nov-Dec;8(6):968-74. doi: 10.1016/j.spinee.2007.11.006. Epub 2008 Jan 16.

  PMID: 18201937 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Surachat Jaroenwareekul, M.D.

CONTACT

+66804599680; surachatjwk@gmail.com

Khanathip Jitphakdee, M.D.

CONTACT

+66912582050; khanathip@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were divided into two groups using computer-generated block-of-four randomization. The experimental group received epidural anesthetic cocktail following endoscopic discectomy, while the control group received placebo.

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: February 22, 2023
• Study Start: May 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: December 30, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

TH (1)