| CTRI Number |
CTRI/2022/01/039431 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
10/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Dexmedetomidine An Analgesic Drug As An Additive In Errector Spinae Plane Block In Spine Surgery |
|
Scientific Title of Study
|
Effect Of Dexmedetomidine As An Adjuvant In Erector Spinae Plane Block On Postoperative Analgesia In Thoracolumbar Spine Surgery With An Opioid Free Anaesthesia Technique: A Prospective Randomized Clinical Trial |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SWATI VERMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE LEVEL 4 NEHRU HOSPITAL PGIMER SECTOR 12 CHANDIGARH
SECTOR 12 CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9896818470 |
| Fax |
|
| Email |
swativerma962@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NIDHI PANDA |
| Designation |
PROFESSOR |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE
LEVEL 4 NEHRU HOSPITAL
PGIMER SECTOR 12
CHANDIGARH
SECTOR 12 CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009525 |
| Fax |
|
| Email |
nidhibp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SWATI VERMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE LEVEL 4 NEHRU HOSPITAL PGIMER SECTOR 12 CHANDIGARH
SECTOR 12 CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9896818470 |
| Fax |
|
| Email |
swativerma962@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
NEHRU HOSPITAL SECTOR 12 PGIMER, CHANDIGARH. 160012 |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SWATI VERMA |
NEUROSURGERY OT AND WARD |
level 5 main ot complex
NEHRU HOSPITAL SECTOR 12 PGIMER CHANDIGARH,160012
Chandigarh
CHANDIGARH |
9896818470
swativerma962@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional etthics committe |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ROPIVACAINE |
ONLY ROPIVACAINE IN ESP BLOCK 0.5 ML/KG FOR POSTOPERATIVE ANALGESIA |
| Intervention |
DEXMEDETOMIDINE |
ADDITION OF DEXMEDETOMIDINE 1MCG/KG IN ERECTOR SPINAE PLANE BLOCK AND COMPARISON OF POSTOPERATIVE PAIN FREE PERIOD |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age :18-65 years
2) Male/female
3) ASA 1 and 2
4) Patient posted for lower thoracic and upper lumber spine surgery (T8-L3) involving 2-4 intervertebral spaces.
5) Nontraumatic cases and Traumatic cases with no other skeletal trauma
6) Patient able to grade severity of pain.
|
|
| ExclusionCriteria |
| Details |
1) Preoperative pain score more than or equal to 5
2) BMI>35kg/m2
3) Pregnant or lactating woman
4) Patient with CAD/bradycardia/heart block/arrhythmias
5) Patient with hepatic/renal failure /CNS pathology
6) Patient with psychiatric disorder.
7) Patient not able to assess and tell severity of pain
8) Patients with allergies to any study medication.
9) Inability to position patient for block
10) ASIA A spine injury
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare duration of pain free period postoperatively in patients receiving ESP block with ropivacaine and dexmedetomidine Vs ropivacaine alone. |
1) postoperative pain scores at 0,2,4,6,8,12 and 24 hrs
2) rescue analgesic requirements during first 24 hour after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare postoperative pain scores at 0,2,4,6,8,12 and 24 hrs
2. To compare rescue analgesic requirements during first 24 hour after surgery.
3. To compare intraoperative qNOX values as a measure of intraoperative analgesia.
4. To compare intraoperative hemodynamic parameters (HR and MAP)
5. To compare patients’ satisfaction regarding postoperative analgesia
in patients receiving ESP block with ropivacaine and dexmedetomidine Vs ropivacaine alone .
|
Post operative period at 0,2,4,8,12,24 hrs and intraoperative |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Opioid Free Anaesthesia (OFA) is a multimodal nonopioid analgesic technique wherein use of opioids in any form is completely eliminated during anaesthesia. This new concept has emerged secondary to potential adverse effects of opioids.In light of the known adverse effects, there have been concerted efforts to reduce opioid exposure by utilising the non-opioid based alternatives analgesic techniques. These non-opioid based techniques are either administered systemically or at nerve root levels.Ketamine is a well-established anaesthetic agent which acts as NMDA receptor in addition to opioid receptors. It provides intense analgesia by reducing glutamate release due to its antagonist action on NMDA receptors and by binding to sigma-opioid receptors. Subanaesthetic doses of ketamine (0.5 mg/kg or less) is very effective in reducing postoperative pain score.Few studies have documented use of ESP block in spine surgery and observed lower pain scores postoperatively in ESP block group compared with systemic opioids. Dexmedetomidine, an alfa 2 receptors agonist, produces analgesia by acting on locus ceruleus of central nervous system and on both presynaptic and postsynaptic alfa 2 receptors at peripheral nervous system.We hypothesize that the addition of dexmedetomidine to local anaesthetic agent (ropivacaine) as an adjuvant in the ESP block will increase the duration of postoperative analgesia in spine surgery in ketamine based OFA technique.In this study, the effect of dexmedetomidine will be assessed as an adjuvant to ropivacaine in ESP block in thoracolumbar spine surgery done under ketamine based OFA on postoperative pain management.
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