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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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