Pre-emptive Caudal Epidural Analgesia With Ropivacaine With or Without Dexamethasone in Lumbosacral Spine Surgery

NCT05904275 | Unknown

• 1 other identifier: NationalTraumaCenter
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lumbosacral spine surgeries are commonly performed under GA. Perioperative pain following spine surgeries not only contributes to significant morbidities but also hampers early mobilization. Perioperative opioids, though relieve pain but hampers consciousness, increase PONV and delays mobilization. Caudal analgesia can be effectively given preemptively to alleviate pain and facilitate early mobilization. Caudal epidural block places the needle through the sacral hiatus into the epidural space to deliver medications. It can be performed as ultrasound guided procedure with very high successful rates. Single shot caudal block with local anesthetic provides analgesia for 2-4 hours but this can be further prolonged by adding adjuvants like opioids, steroids, ketamine, alpha 2 agonists, adrenaline etc. Ropivacaine is a long-acting amide local anesthetic agent which is less lipophilic, less cardiac and central nervous system toxicity with similar duration of analgesia, has lesser motor blockade and facilitates earlier mobilization than bupivacaine. Dexamethasone is a highly potent, long acting glucocorticoid. Caudal dexamethasone prolongs the analgesic duration of the ropivacaine. The aim of this study is to evaluate the role of pre-emptive caudal epidural analgesia for postoperative pain relief in lumbosacral surgeries and to compare the effect of adding dexamethasone to ropivacaine with respect to quality of analgesia, duration of analgesia, hemodynamic effects and associated side effects.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (6)

• Visual Analogue Scale score

  postoperative Visual Analogue Scale score

  At immediate postoperative period

• Visual Analogue Scale score

  postoperative Visual Analogue Scale score

  At 4 hours postoperatively

• Visual Analogue Scale score

  postoperative Visual Analogue Scale score

  At 8 hours postoperatively

• Visual Analogue Scale score

  postoperative Visual Analogue Scale score

  At 12 hours postoperatively

• Visual Analogue Scale score

  postoperative Visual Analogue Scale score

  At 24 hours postoperatively

• Time of rescue analgesia

  Time of VAS score \>4 asking for rescue analgesia

  24 hours

Study Arms (2)

Group RD

EXPERIMENTAL

Group RD - caudal epidural injection with 0.25% ropivacaine 20 ml containing dexamethasone 8 mg (0.5% Ropivacaine 10 ml + 8 mg/2 ml Dexamethasone + 8 ml NS)

Drug: caudal epidural injection

Group R

EXPERIMENTAL

Group R- caudal epidural injection with 0.25% ropivacaine 20 ml

Drug: caudal epidural injection

Interventions

caudal epidural injection DRUG

Preoperative Ultrasound guided caudal epidural injection in lumbosacral spine surgeries for postoperative analgesia.

Also known as: Caudal epidural injection with ropivacaine and dexamethasone

Group R; Group RD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing lumbosacral spine surgeries by posterior approach, including discectomy, laminectomy and laminotomy with or without instrumentation
• ASA PS I and II
• Age 18 to 65 years

You may not qualify if:

• Patients with hypersensitivity to ropivacaine.
• Patients with anomalies of sacral anatomy.
• Local site infection

Sponsors & Collaborators

• National Trauma Center: lead

Related Publications (17)

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  PMID: 17077740 BACKGROUND

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  PMID: 28337460 BACKGROUND

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  PMID: 14620894 BACKGROUND

• Chen CP, Wong AM, Hsu CC, Tsai WC, Chang CN, Lin SC, Huang YC, Chang CH, Tang SF. Ultrasound as a screening tool for proceeding with caudal epidural injections. Arch Phys Med Rehabil. 2010 Mar;91(3):358-63. doi: 10.1016/j.apmr.2009.11.019.

  PMID: 20298824 BACKGROUND

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  PMID: 25035698 BACKGROUND

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  PMID: 15220789 BACKGROUND

• Blanchais A, Le Goff B, Guillot P, Berthelot JM, Glemarec J, Maugars Y. Feasibility and safety of ultrasound-guided caudal epidural glucocorticoid injections. Joint Bone Spine. 2010 Oct;77(5):440-4. doi: 10.1016/j.jbspin.2010.04.016. Epub 2010 Sep 24.

  PMID: 20869897 BACKGROUND

• Yoon JS, Sim KH, Kim SJ, Kim WS, Koh SB, Kim BJ. The feasibility of color Doppler ultrasonography for caudal epidural steroid injection. Pain. 2005 Nov;118(1-2):210-4. doi: 10.1016/j.pain.2005.08.014. Epub 2005 Oct 4.

  PMID: 16213088 BACKGROUND

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  PMID: 19578805 BACKGROUND

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  PMID: 20084409 BACKGROUND

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  PMID: 28243379 BACKGROUND

• Kalappa S, Sridhara RB, Kumaraswamy S. Dexmedetomidine as an Adjuvant to Pre-Emptive Caudal Epidural Ropivacaine for Lumbosacral Spine Surgeries. J Clin Diagn Res. 2016 Jan;10(1):UC22-4. doi: 10.7860/JCDR/2016/15286.7145. Epub 2016 Jan 1.

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• Samagh N, Pai RK, Mathews TK, Jangra K, Varma RG. Pre-emptive caudal epidural analgesia with ropivacaine for lumbosacral spine surgery: A randomized case control study. J Anaesthesiol Clin Pharmacol. 2018 Apr-Jun;34(2):237-241. doi: 10.4103/joacp.JOACP_72_17.

  PMID: 30104836 BACKGROUND

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• Kalappa S, Sridhar RB, Nagappa S. Comparing the Efficacy of Caudal with Intravenous Dexamethasone in the Management of Pain Following Lumbosacral Spine Surgeries: A Randomized Double Blinded Controlled Study. Anesth Essays Res. 2017 Apr-Jun;11(2):416-420. doi: 10.4103/0259-1162.194581.

  PMID: 28663633 BACKGROUND

• Baliga S, Treon K, Craig NJ. Low Back Pain: Current Surgical Approaches. Asian Spine J. 2015 Aug;9(4):645-57. doi: 10.4184/asj.2015.9.4.645. Epub 2015 Jul 28.

  PMID: 26240729 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jay Pr Thakur, MD,FIPM

  National Academy of Medical Science, Nepal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jay Pr Thakur, MD, FIPM

CONTACT

9849001429; dr_jay2002@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: June 15, 2023
• Study Start: August 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share