| CTRI Number |
CTRI/2025/07/091982 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Dexamethasone Dose Comparison as an Adjuvant to Levobupivacaine in Lower Abdominal Surgery. |
|
Scientific Title of Study
|
Comparison of Two Different Doses of Dexamethasone as an Adjuvant to Intrathecal Levobupivacaine on Analgesic Efficacy in Lower Abdominal Surgeries: A Randomised Controlled Study |
| 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 Vibhor Gupta |
| Designation |
Associate Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Dilshad Garden, Shahadra
East Delhi 110095
India
East
DELHI
110095
India |
| Phone |
9971068804 |
| Fax |
|
| Email |
vgupta@ucms.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RS Rautela |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Dilshad Garden, Shahadra
East Delhi 110095
India
East
DELHI
110095
India |
| Phone |
9871741419 |
| Fax |
|
| Email |
rsramb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TENZIN SONAM |
| Designation |
Post Graduate student |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Dilshad Garden, Shahadra
East Delhi 110095
India
East
DELHI
110095
India |
| Phone |
9205737881 |
| Fax |
|
| Email |
tenzindna@gmail.com |
|
|
Source of Monetary or Material Support
|
| UCMS and GTB Hospital, Shahdara, New Delhi-110095 |
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
Room no. 531 B, UCMS and GTB Hospital, Dilshad Garden,New Delhi-110095, India |
| Type of Sponsor |
Government 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 Tenzin Sonam |
UCMS and GTB Hospital |
2nd floor, OT Block, Department of Anaesthesia and Critical Care, Dilshad Garden-110095
North East
DELHI |
9205737881
tenzindna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Human Research |
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 |
| Intervention |
Subarachnoid block |
Subarachnoid block with 0.5% isobaric levobupivacaine with 2mg of dexamethasone as an adjuvant will be given to patients undergoing lower abdominal surgeries, 15 minutes before the procedure begins |
| Comparator Agent |
Subarachnoid block |
Subarachnoid block with 0.5% isobaric levobupivacaine with 4mg of dexamethasone as an adjuvant will be given to patients undergoing lower abdominal surgeries, 15 minutes before the procedure begins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA grade I or II, between 18-65 years of age, and height 150-180 cm, scheduled for lower abdominal surgeries under subarachnoid block will be
included in the study. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Non-consenting for subarachnoid block
Infection at injection site
Coagulopathy
Drugs addicts and chronic alcoholics
Any spine deformity
On antiarrhythmics
Patients with history suggestive of space occupying lesion, increased intracranial
tension, seizure disorder, pre-existing neurological deficit, hepatic and renal disease
and pre-existing diabetes mellitus. |
|
|
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 |
| Duration of effective analgesia with two different doses of dexamethasone as an adjuvant to nitrate al levobupivacaine in lower abdominal surgeries |
The time from the subarachnoid block to the time of patient’s first complaint of pain VAS more than equal to 3 and till 24 hours from subarachnoid block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of sensory block
Quality of motor block
Side effects nausea, vomitting, hypotension, bradycardia, hyperglycaemia, hypernatremia & others |
The time from the subarachnoid block to the time of first complaint of pain VAS more than equal to 3 & till 24 hours from subarachnoid block |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
14/08/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Rationale: Subarachnoid block is the most commonly used technique for lower abdominal surgery, but it provides limited duration of analgesia when the local anaesthetics are used alone. Thus, additives can be added to prolong the analgesic efficacy. Dexamethasone has proven its effectiveness for this purpose when used with local anaesthetics. However, the search of literature did not find study comparing the analgesic efficacy of two different doses of dexamethasone (2 mg and 4 mg) as an adjuvant to levobupivacaine in subarachnoid block in patients undergoing lower abdominal surgeries.
Aim: To compare the analgesic efficacy of two different doses of dexamethasone as an adjuvant to intrathecal levobupivacaine in lower abdominal surgeries.
Primary objective: Analgesic efficacy: Duration of effective analgesia (Time from the subarachnoid block to the time of patient’s first complaint of pain (VAS > 3).
Methods: On the day before surgery, the patients will be visited to explain about the procedure, the type of medication to be used, its purpose and potential side effects. Written informed consent will be obtained. For premedication, patients will be prescribed Tab Alprazolam 0.25 mg and Tab Ranitidine 150 mg, to be taken the night before surgery and repeated on the morning of the procedure. On the day of surgery, following the pre-anaesthetic assessment, the patient will be transferred to the operating theatre and positioned on the operating table. Standard monitoring, including non-invasive oscillometric blood pressure, Lead I ECG, and pulse oximetry, will be attached, and baseline vital parameters (Heart Rate, Blood Pressure, SpOz and Respiratory Rate), Serum Na* and Blood Sugar levels will be recorded. Intravenous (IV) access with 18 G IV cannula will be secured, and preloading with Ringer’s lactate solution will be initiated at a dose of 15 mL/kg administered over 15-30 minutes.
OUTCOME MEASURES 1. Analgesic efficacy: Duration of effective analgesia (Time from the subarachnoid block to the time of patient’s first complaint of pain (VAS 3). 2. Quality of sensory block. 3. Quality of motor block. 4. Side effects, if any.
Statistical Analysis: Al the data collected will be managed in MS excel. The quantitative data will be represented as mean (SD) & qualitative data will be represented as frequency. The normality of the quantitative data set will be checked using KOLMOGROV SMIRNOV TEST. The comparison between the 2 independent groups based on continuous variables will be done using Independent T-test/ Mann Whitney U Test based on result of normality. The threshold of statistical significance is p-value <0.05 |