MedTrace Logo

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

NCT05904275 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-06-15

No results posted yet for this study

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

Interventions

DRUG

caudal epidural injection

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

Sponsors & Collaborators

  • National Trauma Center

    lead OTHER

Principal Investigators

  • Jay Pr Thakur, MD,FIPM · National Academy of Medical Science, Nepal

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-02-28
Completion
2024-02-28

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05904275 on ClinicalTrials.gov