CTRI Number |
CTRI/2025/03/082125 [Registered on: 11/03/2025] Trial Registered Prospectively |
Last Modified On: |
10/03/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Other |
Public Title of Study
|
Comparison of intrathecal butorphanol and nalbuphine as an adjuvant to levobupivacaine in spinal anaesthesia |
Scientific Title of Study
|
Evaluation of intrathecal butorphanol and nalbuphine as an adjuvant to levobupivacaine in subarachnoid block: a comparative 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 |
Akhilesh Chopra |
Designation |
PG Resident |
Affiliation |
School of Medical Sciences and Research Sharda University Greater Noida |
Address |
Department of Anaesthesiology
School of Medical Sciences and Research Sharda University
Gautam Buddha Nagar
UTTAR PRADESH
201306
India
Gautam Buddha Nagar UTTAR PRADESH 201306 India |
Phone |
9370729800 |
Fax |
|
Email |
akhileshchopra30@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manish Kumar Agarwal |
Designation |
Professor |
Affiliation |
School of Medical Sciences and Research Sharda University Greater Noida |
Address |
Department of Anaesthesiology
School of Medical Sciences and
Research Sharda University
Gautam Budh Nagar
UTTAR PRADESH
201306
INDIA
Gautam Buddha Nagar UTTAR PRADESH 201306 India |
Phone |
9838706199 |
Fax |
|
Email |
dr.manishagarwal09@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Manish Kumar Agarwal |
Designation |
Professor |
Affiliation |
School of Medical Sciences and Research Sharda University Greater Noida |
Address |
Department of Anaesthesiology
School of Medical Sciences and
Research Sharda University
Gautam Budh Nagar
UTTAR PRADESH
201306
INDIA
UTTAR PRADESH 201306 India |
Phone |
9838706199 |
Fax |
|
Email |
dr.manishagarwal09@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology School of Medical Sciences and Research Sharda University Greater Noida |
|
Primary Sponsor
|
Name |
Department of Anaesthesiology School of Medical Sciences and Research, Sharda University |
Address |
Plot no. 32,34 Knowledge Park 3, Greater Noida, Gautam Budh Nagar, Uttar Pradesh 201306 India |
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 |
Manish Kumar Agarwal |
SMS&R, Sharda University |
Department of Anaesthesia SMS&R
and Sharda Hospital, Greater Noida Gautam Buddha Nagar UTTAR
PRADESH Gautam Buddha Nagar UTTAR PRADESH |
9838706199
dr.manishagarwal09@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee SMS&R |
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 |
Butorphanol Nalbuphine and Levobupivacaine |
Evaluation of intrathecal butorphanol and nalbuphine as an adjuvant to levobupivacaine in subarachanoid block: a comparative study
3 groups consisting of 25 patients each
Group LB: Injection levobupivacaine, 0.5% 3.0 ml plus Butorphanol 50 mcg, 0.2 ml
Group LN: Injection levobupivacaine, 0.5% 3.0 ml plus Nalbuphine 500 mcg, 0.2 ml
Group LS: Injection levobupivacaine, 0.5% 3.0 ml plus Normal Saline 0.2 ml
Drugs will be given intrathecally |
Comparator Agent |
Butorphanol Nalbuphine and Levobupivacaine |
Evaluation of intrathecal butorphanol and nalbuphine as an adjuvant to levobupivacaine in subarachanoid block: a comparative study
3 groups consisting of 25 patients each
Group LB: Injection levobupivacaine, 0.5% 3.0 ml plus Butorphanol 50 mcg, 0.2 ml
Group LN: Injection levobupivacaine, 0.5% 3.0 ml plus Nalbuphine 500 mcg, 0.2 ml
Group LS: Injection levobupivacaine, 0.5% 3.0 ml plus Normal Saline 0.2 ml
Drugs will be given intrathecally |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patient scheduled for surgery under subarachnoid block 2.Age 18-60 years 3. Both genders 4. ASA grade I and II |
|
ExclusionCriteria |
Details |
1.ASA grade III and IV 2.Patient refusal to participate in study 3.Morbid obesity 4. Patient with history of adverse response to study drugs 5. Patient with pre-existing neurological or spinal disease, cardiovascular disease, renal, hepatic or any other systemic disease. 6. Pregnant females 7 Coagulopathy or bleeding diathesis.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
To compare the effect of intrathecal nalbuphine versus butorphanol as an adjuvant to 0.5% Levobupivacaine in subarachnoid block in respect to:
1. Time of onset and duration of sensory blockade assessed by pinprick and Visual Analog Score (VAS).
2. Time of onset and duration of motor blockade assessed by modified Bromage scale. |
Post operative period
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Changes in vitals parameters-
Heart rate (HR), Noninvasive Blood Pressure (NIBP) & Oxygen Saturation (SPO2).
2. Requirement of first analgesic rescue in postoperative period in the first 24 hours. |
Post operative period |
|
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
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
21/03/2025 |
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="6" 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
|
Neuraxial anesthesia is commonly performed for all surgical procedures carried on lower abdomen, pelvis and lower limbs to provide adequate surgical anesthesia and analgesia. It has a definite advantage over general anesthesia by blocking nociceptive impulses from the operative site, reduced blood loss and decreased incidence of deep vein thrombosis. Levobupivacaine has become popular for central neuraxial blocks in this century. The main advantage includes ease of technique and reliability. Levobupivacaine a pure s-enantiomers of bupivacaine are safer alternative for regional anaesthesia than its counterpart with lower toxicity profile. Opioids are added to local anesthetic drugs intrathecally to provide synergistic effect and to improve the quality of intraoperative and postoperative analgesia. These agents when combined together result in a reduction in the dose of both classes of drugs, decreasing the likelihood of side effects related to each.
Extensive search of literature reveals that though the studies have been conducted with our additives with the drug bupivacaine, but a specific study comparing the additive effect of both the drugs with the recently introduced drug Levobupivacaine and a suitable dose required intrathecally has not been done extensively. Therefore, the present study is designed to compare the effect of intrathecal butorphanol and nalbuphine as an adjuvant to levobupivacaine in subarachnoid block. The specific outcome measures to define the performance of our study will primarily include comparing the effect of both the adjuvant drugs administered on the duration of motor and sensory blockade. |