| CTRI Number |
CTRI/2018/12/016742 [Registered on: 19/12/2018] Trial Registered Prospectively |
| Last Modified On: |
12/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Nalbuphine versus clonidine with hyperbaric bupivacaine for spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of nalbuphine versus clonidine as an intrathecal adjuvant to hyperbaric bupivacaine in orthopedic lower limb surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujata Chaudhary |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences |
| Address |
Department of Anaesthesia and Critical Care,UCMS and GTB HOSPITAL,Dilshad Garden
North East
DELHI
110095
India |
| Phone |
9999051546 |
| Fax |
|
| Email |
sujatac462@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Chaudhary |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences |
| Address |
Department of Anaesthesia and Critical Care,UCMS and GTB HOSPITAL,Dilshad Garden
North East
DELHI
110095
India |
| Phone |
9999051546 |
| Fax |
|
| Email |
sujatac462@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Heena Agrawal |
| Designation |
Post Graduate 1st year |
| Affiliation |
University College of Medical Sciences |
| Address |
Department of Anaesthesia and Critical Care,UCMS and GTB HOSPITAL,Dilshad Garden
North East
DELHI
110095
India |
| Phone |
8826613093 |
| Fax |
|
| Email |
dr.heenaagrawal93@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden , Delhi |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Dilshad Garden
New Delhi |
| 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 Heena Agrawal |
Department of Ananesthesia and Critical Care, UCMS and GTB HOSPITAL |
Dilshad Garden
North East
DELHI |
8826613093
dr.heenaagrawal93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Human Research (IEC-HR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S899||Unspecified injury of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clonidine group |
Patients in this group will receive single shot of 15 mg of 0.5% of hyperbaric bupivacaine(3.0ml)with 30mcg of clonidine(0.5ml) before the surgery through spinal anaesthesia |
| Intervention |
Control group |
Patients in this group will receive single shot 15 mg of 0.5% of hyperbaric bupivacaine(3.0ml)with 0.9% of normal saline(0.5ml) before the surgery through spinal anaesthesia |
| Comparator Agent |
Nalbuphine group |
Patients in this group will receive single shot of 15 mg of 0.5% of hyperbaric bupivacaine(3.0ml)with 1mg of nalbuphine(0.5ml) before the surgery through spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA grade I and II who are undergoing orthopedic lower limb surgery with height of >150cm and <180cm. |
|
| ExclusionCriteria |
| Details |
1.Patients with known allergy to drugs involved in the study.
2.Patients with contraindications to central neuraxial block like patients with coagulations abnormalities, increased intracranial pressure, local sepsis in spinal lumbar region.
3.Patients with weight>120kg.
4.Patient with history of chronic pain or long term opioid use.
5.Patient refusal.
6.Multiple fractures precluding assessment of anaesthesia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The duration of analgesia following intrathecal test drug solution administration |
0,2,4,8,10,15,20 and 30 minutes following drug administration and then every 15 minutes during intra operative period and every 30 minutes dring 2 hours of post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time of onset, maximum level, time to achieve maximum level and duration of sensory block
2.Time of onset, intensity and duration of motor block
3.Postoperative pain assessment (VAS) and total analgesic requirement in first 24 hours
|
0,2,4,8,10,15,20 and 30 minutes following drug administration and then every 15 minutes during intra operative period and every 30 minutes dring 2 hours of post operative period and then at 4th,8th,12th hour and 24 hours respectively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2018 |
| Date of Study Completion (India) |
30/04/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Rationale: Lower limb fracture is the commonest orthopedic trauma requiring surgery. Spinal anesthesia is the preferred choice for orthopedic lower limb surgeries. Due to its limited duration of block, intrathecal adjuvants are often used to prolong the duration of anesthesia. Opioids are commonly used intrathecal adjuvant but, are also associated with side effects like hypotension, bradycardia, pruritis etc. Recently, nalbuphine has been safely used as intrathecal adjuvant and found to be promising without additional side effects. Intrathecal clonidine is known to prolong analgesia and quality of subarachanoid block. Few studies have compared nalbuphine with clonidine but the results reported are inconsistent. Aim: Comparison of nalbuphine versus clonidine as intrathecal adjuvant to hyperbaric bupivacaine in orthopedic lower limb surgeries. Objectives: To compare the effect of nalbuphine versus clonidine as intrathecal adjuvant to bupivacaine and study its effect on: Primary objective: To know the duration of post operative analgesia Secondary objectives: 1. Sensory block: highest level and duration of block 2. Motor block: Onset, intensity and duration of block 3. Adverse effects Setting: The study will be conducted in Department of Anesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi. Study Design: Randomized double blind controlled study. Duration: November 2018 to April 2020 Population/participants: Patients belonging to ASA I and ASA II, between the age of 18-60 years and height of >150cm and <180cm will be included in the study. Sample Size: Considering the variability of 6.04 minutes, 30.76 minutes and 5.85 minutes in duration of analgesia with nalbuphine 0.8mg, clonidine 15mcg and control respectively from previous studies.9, 12 Now to estimate a difference of 50 minutes among these drugs at α=5% and Power=90%, a sample size of 10 patients is required in each group. Due to availability of resources and time, we propose to consider 21 patients in each group. 63 patients will be divided into three groups of 21 each using a computer generated random number table. Methods: Under all aseptic precautions subarachanoid block will be performed and patients will receive 3.5 ml of test drug solution containing 15mg of bupivacaine along with either 1mg of nalbuphine or 30mcg of clonidine or 0.9% of normal saline according to the groups allocated. The test drug solution will be prepared by anesthesiologist not involved in the study. Patients will be assessed for characteristics of spinal anesthesia (sensory and motor block), sedation score, hemodynamic parameters, pain score and side effects. Statistical Analysis: Between the 3 groups comparison will be done by one way ANOVA followed by TUKEY’s test. Hemodynamic parameters will be compared by repeated measure ANOVA and followed by DUNNETT’s test. Qualitative parameters will be compared using Chi-square test/Fischer’s exact test. A p-value of <0.05 will be considered significant. |