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

Primary Purpose

Post Operative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
caudal epidural injection
Sponsored by
National Trauma Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: Patients with hypersensitivity to ropivacaine. Patients with anomalies of sacral anatomy. Local site infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group RD

    Group R

    Arm Description

    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)

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

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale score
    postoperative Visual Analogue Scale score
    Visual Analogue Scale score
    postoperative Visual Analogue Scale score
    Visual Analogue Scale score
    postoperative Visual Analogue Scale score
    Visual Analogue Scale score
    postoperative Visual Analogue Scale score
    Visual Analogue Scale score
    postoperative Visual Analogue Scale score
    Time of rescue analgesia
    Time of VAS score >4 asking for rescue analgesia

    Secondary Outcome Measures

    Full Information

    First Posted
    January 27, 2023
    Last Updated
    June 13, 2023
    Sponsor
    National Trauma Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05904275
    Brief Title
    Pre-emptive Caudal Epidural Analgesia With Ropivacaine With or Without Dexamethasone in Lumbosacral Spine Surgery
    Official Title
    A Randomized Case Control Study of Pre-emptive Caudal Epidural Analgesia With Ropivacaine With and Without Dexamethasone for Lumbosacral Spine Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2024 (Anticipated)
    Study Completion Date
    February 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Trauma Center

    4. Oversight

    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

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Operative Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group RD
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    Group R
    Arm Type
    Experimental
    Arm Description
    Group R- caudal epidural injection with 0.25% ropivacaine 20 ml
    Intervention Type
    Drug
    Intervention Name(s)
    caudal epidural injection
    Other Intervention Name(s)
    Caudal epidural injection with ropivacaine and dexamethasone
    Intervention Description
    Preoperative Ultrasound guided caudal epidural injection in lumbosacral spine surgeries for postoperative analgesia.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale score
    Description
    postoperative Visual Analogue Scale score
    Time Frame
    At immediate postoperative period
    Title
    Visual Analogue Scale score
    Description
    postoperative Visual Analogue Scale score
    Time Frame
    At 4 hours postoperatively
    Title
    Visual Analogue Scale score
    Description
    postoperative Visual Analogue Scale score
    Time Frame
    At 8 hours postoperatively
    Title
    Visual Analogue Scale score
    Description
    postoperative Visual Analogue Scale score
    Time Frame
    At 12 hours postoperatively
    Title
    Visual Analogue Scale score
    Description
    postoperative Visual Analogue Scale score
    Time Frame
    At 24 hours postoperatively
    Title
    Time of rescue analgesia
    Description
    Time of VAS score >4 asking for rescue analgesia
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Patients with hypersensitivity to ropivacaine. Patients with anomalies of sacral anatomy. Local site infection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jay Pr Thakur, MD, FIPM
    Phone
    9849001429
    Email
    dr_jay2002@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jay Pr Thakur, MD,FIPM
    Organizational Affiliation
    National Academy of Medical Science, Nepal
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Pre-emptive Caudal Epidural Analgesia With Ropivacaine With or Without Dexamethasone in Lumbosacral Spine Surgery

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