| CTRI Number |
CTRI/2024/08/073149 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Dose Response of Intravenous Dexamethasone on post Operative Pain With Subarachnoid Block In Lower Limb Osteoarticular Surgery. |
|
Scientific Title of Study
|
Dose response of Intravenous Dexamethasone on post operative pain with Subarachnoid block in Lower limb Osteoarticular surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SONAM |
| Designation |
PG 1ST YEAR RESIDENT |
| Affiliation |
school of medical sciences and research, Sharda Hospital |
| Address |
Department of Anesthesiology, school of medical sciences and research, plot no 32,34, Knowledge Park 3, greater noida Gautam Buddha Nagar UTTAR PRADESH 201310 India
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
8477903375 |
| Fax |
|
| Email |
sonamrajput881@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Uttam Chandra Verma |
| Designation |
Professor |
| Affiliation |
school of medical sciences and research |
| Address |
Department of Anesthesiology, school of medical sciences and research, plot no 32,34, Knowledge Park 3, greater noida Gautam Buddha Nagar UTTAR PRADESH 201310 India
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
9968604211 |
| Fax |
|
| Email |
uttam.verma@sharda.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr SONAM |
| Designation |
pg 1st year resident anaesthesia |
| Affiliation |
school of medical sciences and research |
| Address |
Department of Anesthesiology, school of medical sciences and research, plot no 32,34 Knowledge Park 3, greater noida Gautam Buddha Nagar UTTAR PRADESH 201310 India
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
08477903375 |
| Fax |
|
| Email |
sonamrajput881@gmail.com |
|
|
Source of Monetary or Material Support
|
| school of medical sciences and research,
plot no. 32,34, knowledge park 3, greater noida, uttar pradesh, 201310 |
|
|
Primary Sponsor
|
| Name |
school of medical sciences and research |
| Address |
plot no 32,34, knowledge park 3, greater Noida |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonam |
sharda hospital ,school of medical sciences and research, |
Department of Anesthesiology, 2nd floor,B block Gautam Buddha Nagar UTTAR PRADESH, 201310, India. Gautam Buddha Nagar UTTAR PRADESH |
08477903375
sonamrajput881@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Dexamethasone |
Patient will receive Intravenous Dexamethasone 0.075mg/kg in 3ml. |
| Comparator Agent |
Intravenous Dexamethasone |
Patient will receive Intravenous Dexamethasone 0.15 mg/kg in 3ml. |
| Comparator Agent |
Intravenous Dexamethasone |
Patient will receive normal saline 3ml intravenously |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for lower limb osteoarticular surgery under subarachnoid block.
2. ASA grade I - II
3. Age 18- 60 yrs.
4. Height 150-170 cm.
5. BMI less than kg per metre square.
6. Both genders
|
|
| ExclusionCriteria |
| Details |
1.History of allergy to local anaesthetic.
2.History of chronic use of corticosteroids, opioids and any other analgesics.
3.Pregnant females.
4.History of endocrine disease- Diabetes mellitus and thyroid disease
5.History of CNS, cardiovascular and renal disease.
6.Presence of active infection in the body. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the duration of analgesia with two different doses of IV Dexamethasone supplemented after subarachnoid block given with hyperbaric Bupivacaine in lower limb osteoarticular surgery. |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effect on with regards to:
(a)VAS score
(b)Opioid (Fentanyl) consumption
(c)Duration of sensory and motor block
(d)Postoperative nausea and vomiting
(e)Blood glucose levels.
|
24 Hoours |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/09/2024 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute
postoperative pain causes patient discomfort and also impedes the recovery. Regional blocks with long-acting local anaesthetics
are helpful to achieve surgical anaesthesia and longer duration of post
operative analgesia. Spinal anaesthesia is widely used in lower abdominal
surgeries, as it plays a crucial role in relieving postoperative pain and
enabling ambulatory anaesthesia1. It is safe, cost effective and
easy to perform technique, which provides a denser block and so more preferred2.
Multimodal
analgesia is method of pain management in which combined medication groups
include (local anaesthetics, opioids, NSAIDS, acetaminophen and alpha-2
agonists, gabapentinoids, dexamethasone) are used for pain relief.
It
has been found that many drugs, such as opioids (morphine, fentanyl, and
sufentanil), α2 adrenergic agonists (dexmedetomidine and clonidine), magnesium
sulphate, neostigmine, ketamine, and midazolam, can be used as adjuvants for
intrathecal local anaesthetics to improve the quality of spinal anaesthesia and
post-operative pain3.
Dexamethasone
is a potent long acting glucocorticoid with plasma half-life of 36 hrs having
minimal mineralocorticoid activity, with anti-inflammatory and analgesic
property. It is regarded as one of the ideal perioperative drugs being readily
available, cheap, suppresses inflammation, prevent and treats postoperative
nausea and vomiting, promotes appetite and provide good analgesia, when given intravenously
and as an adjunct to peripheral nerve blocks. It provides good quality of
recovery and early discharge of patients.
It acts on hypothalamic pituitary
adrenal axis to produce its effect. Systemic administration of dexamethasone
has been found to possess anti-inflammatory and immunosuppressive properties,
which may contribute to prolonged analgesia when administered intravenously4.
Various studies suggest that intravenous
dexamethasone as an adjunct with local anaesthetic prolongs the duration of
spinal anaesthesia and also provides post-operative analgesia
IV administration of dexamethasone improves postoperative VAS score and
decreases overall postoperative
analgesic consumption in patients given subarachnoid block with hyperbaric
bupivacaine5. Higher dose of dexamethasone is superior to lower
dose, although both prolongs analgesia and were effective in reducing
postoperative opioid consumption.
Various studies show that duration
of sensory and motor block was significantly higher in patient receiving higher
dose of intravenous dexamethasone as compared to lower dose5,6
Lacunae in existing knowledge
However, to the
best of our knowledge and also after searching quite a number of articles and
extensive literature search, it has been found that no previous studies have compared
the analgesic effect of two doses of intravenous dexamethasone, (0.15 mg/kg and
0.075 mg/kg) supplemented after subarachnoid block given with hyperbaric Bupivacaine in lower limb
osteoarticular surgery. Therefore,
we will compare the effects of two different doses of intravenous dexamethasone
on postoperative pain in patients given subarachnoid block with 0.5% hyperbaric
bupivacaine.
|