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

June 13, 2023 updated by: Dr. Jay Prakash Thakur, National Trauma Center

A Randomized Case Control Study of Pre-emptive Caudal Epidural Analgesia With Ropivacaine With and Without Dexamethasone for Lumbosacral Spine Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Patients will be allocated in one of the two groups, I and II, consisting of 30 each, using a lottery based random number. A box containing 60 chits, with 30 labelled as group I and other 30 as group II, will be given to each patient and will be asked to take out 1 chit. The group allocated will be written in separate paper by an anesthesiologist, who will also prepare drugs. Decoding will be done later after completion of all data collection. The patient in Group I will be given 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) and group II will be give 0.25% ropivacaine 20 ml. All the data collection will be done by another anesthesiologist, not involved in group allocation, drug preparation and administration.

At preoperative visit, all patients will be made familiar with VAS score for pain assessment and will be recorded. At operation theatre, standard American Society of Anesthesiologists (ASA) monitoring, including electrocardiography, noninvasive blood pressure, pulse oximetry and endtidal carbon dioxide, will be applied and measured. Patient's vitals will be recorded at preinduction, induction, postintubation, after caudal injection, time of incision, and at 15 min intervals till half an hour after completion of surgery. Intravenous (IV) line will be secured, and inj. Ringer Lactate (RL) 500 ml will be administered. Anesthesia will be induced with inj. Midazolam 0.04 mg/kg, inj. Fentanyl 2 mcg/kg, inj. Propofol in titrated dosages till loss of consciousness and inj. Rocuronium 0.6 mg/kg to facilitate intubation. The time of induction will be noted. After intubation and securing airway, foley's catheterization of bladder will be done and patient will be positioned in prone position for surgery in which caudal epidural injection will also be given. After painting and draping, ultrasound guided visualization of sacral hiatus will be done. In longitudinal view, using in plane technique, 22 gauge Quincke's spinal needle will be inserted below sacrococcygeal ligament. After negative aspiration of blood and CSF, epidural space will also be confirmed by injecting 3 ml of normal saline. The prepared study drugs will be injected. The time of caudal drug administration will be noted. The surgical incision will be allowed after 20 minutes of injecting drugs in both groups, to allow fixation of drugs. The time of surgical incision will be noted. Anaesthesia will be maintained on oxygen, isoflurane and intermittent boluses of muscle relaxants. Inj. Paracetamol 1 g and inj. Diclofenac 75 mg will be given intravenously, around 1 hour before anticipated completion of surgery. Neuromuscular blockade will be reversed with inj. Neostigmine 0.05 mg/kg and inj. Glycopyrrolate 0.01 mg/kg. Patients will be extubated after return of consciousness and muscle power, and will be shifted to post-operative ward. VAS score will be recorded at immediate postoperative period, 4, 8, 12 and 24 hours. All patients will be given inj. Paracetamol 1 g 8 hourly and inj. Diclofenac 75 mg 12 hourly as an intravenous infusion. If any patients have VAS ≥ 4 at any time, rescue analgesia in form of inj. Pethidine 50 mg with inj. Promethazine 25 mg will be given intramuscularly. The time to demand of first dose of supplemental (rescue) analgesic medication will be recorded. Any complications and adverse drug reactions will be recorded.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with hypersensitivity to ropivacaine.
  2. Patients with anomalies of sacral anatomy.
  3. Local site infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group RD
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
Preoperative Ultrasound guided caudal epidural injection in lumbosacral spine surgeries for postoperative analgesia.
Other Names:
  • Caudal epidural injection with ropivacaine and dexamethasone
Experimental: Group R
Group R- caudal epidural injection with 0.25% ropivacaine 20 ml
Drug: caudal epidural injection
Preoperative Ultrasound guided caudal epidural injection in lumbosacral spine surgeries for postoperative analgesia.
Other Names:
  • Caudal epidural injection with ropivacaine and dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale score
Time Frame: At immediate postoperative period
postoperative Visual Analogue Scale score
At immediate postoperative period
Visual Analogue Scale score
Time Frame: At 4 hours postoperatively
postoperative Visual Analogue Scale score
At 4 hours postoperatively
Visual Analogue Scale score
Time Frame: At 8 hours postoperatively
postoperative Visual Analogue Scale score
At 8 hours postoperatively
Visual Analogue Scale score
Time Frame: At 12 hours postoperatively
postoperative Visual Analogue Scale score
At 12 hours postoperatively
Visual Analogue Scale score
Time Frame: At 24 hours postoperatively
postoperative Visual Analogue Scale score
At 24 hours postoperatively
Time of rescue analgesia
Time Frame: 24 hours
Time of VAS score >4 asking for rescue analgesia
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Trauma Center

Investigators

  • Principal Investigator: Jay Pr Thakur, MD,FIPM, National Academy of Medical Science, Nepal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NationalTraumaCenter

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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