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CTRI Number  CTRI/2018/02/012157 [Registered on: 26/02/2018] Trial Registered Retrospectively
Last Modified On: 22/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparison of two drugs given in spinal anaesthesia for postoperative pain relief in patients undergoing lower limb orthopaedic surgery. 
Scientific Title of Study   Comparison of post operative analgesic effects of intrathecal nalbuphine and intrathecal clonidine in patients undergoing elective lower limb orthopaedic surgeries : a prospective randomized double blind study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravi Bhat 
Designation  Associate Professor 
Affiliation  Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad 
Address  Department of Anaesthesia Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad Manjushree Nagar Sattur Dharwad
Manjushree Nagar Sattur Dharwad
Dharwad
KARNATAKA
580009
India 
Phone  0836-2477755  
Fax    
Email  kakkodravi@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Bhat 
Designation  Associate Professor 
Affiliation  Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad 
Address  Department of Anaesthesia Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad Manjushree Nagar Sattur Dharwad
Manjushree Nagar Sattur Dharwad
Dharwad
KARNATAKA
580009
India 
Phone  0836-2477755  
Fax    
Email  kakkodravi@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Krishna Sagar SR 
Designation  Postgraduate Student 
Affiliation  Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad 
Address  Department of Anaesthesia Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad Manjushree Nagar sattur dharwad
Manjushree Nagar Sattur Dharwad
Dharwad
KARNATAKA
580009
India 
Phone  0836-2477755  
Fax    
Email  sriksagar@gmail.com  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad Manjushree Nagar Sattur Dharwad Kranataka -580009  
 
Primary Sponsor  
Name  Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital Dharwad 
Address  Manjushree Nagar Sattur Dharwad 580009 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 
Ravi Bhat  Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad  Department of Anaesthesia IInd Floor Operation Theatre Complex
Dharwad
KARNATAKA 		 0836-2477755

kakkodravi@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDMIEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  fracture femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3. Group C: - 2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of 60 μg clonidine.  the patients were randomly allocated into nalbuphine group (Group N), Clonidine group (Group C) or control group (Group Z) using sealed envelope technique into three groups of 33 each, which was opened just before shifting the patient to the operation theatre. 1. Group Z: -2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of Normal saline. 2. Group N: - 2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of 0.8 mg nalbuphine. 3. Group C: - 2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of 60 μg clonidine. 
Comparator Agent  Group Z: -2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of Normal saline.   The patients were randomly allocated into nalbuphine group (Group N), Clonidine group (Group C) or control group (Group Z) using sealed envelope technique into three groups of 33 each, which was opened just before shifting the patient to the operation theatre. 1. Group Z: -2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of Normal saline. 2. Group N: - 2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of 0.8 mg nalbuphine. 3. Group C: - 2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of 60 μg clonidine. 
Comparator Agent  Group Z: -2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of Normal saline. 2. Group N: - 2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of 0.8 mg nalbuphine. 3. Group C: - 2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of 60 μg clonidine.   he patients were randomly allocated into nalbuphine group (Group N), Clonidine group (Group C) or control group (Group Z) using sealed envelope technique into three groups of 33 each, which was opened just before shifting the patient to the operation theatre. 1. Group Z: -2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of Normal saline. 2. Group N: - 2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of 0.8 mg nalbuphine. 3. Group C: - 2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of 60 μg clonidine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Aged between 18 and 60 years
ASA Physical status 1, 2 and 3
Patients undergoing elective lower limb long bone orthopaedic surgery under sub arachnoid block.  
 
ExclusionCriteria 
Details  1. Patients with ischemic heart disease, neurological or psychiatric disorders, renal or hepatic insufficiency. 2. Pregnant or lactating women. 3. Obese as defined by a BMI of more than 30 kg/m2. 4. Patients on α antagonists. 5. Patients allergic to the medications being used. 6. CNS and local infections. 7. Spine deformities, raised intracranial pressure and progressive neurological disorders. 8. Those parents who refuse consent 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain free Interval After Surgery
No Of rescue Pain Medication needed in first 24 hours of surgery.
Average Visual Analogue Scale for Pain during assessment period. 		 First 24 hours after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
duration of analgesia
pain score 		 24 hours 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
Final Enrollment numbers achieved (Total)= "99"
Final Enrollment numbers achieved (India)="99" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/02/2015 
Date of Study Completion (India) 30/05/2017 
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)   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   SOURCE OF DATA:  This prospective, randomized, double blind interventional study was carried out in the department of anaesthesiology, SDM College of Medical Sciences and Hospital, Dharwad from December 2015 to May 2017 with the permission from hospital ethical committee along with well-informed written consent from all patients undergoing elective lower limb orthopaedic surgeries requiring sub-arachnoid blockade as a modality of anaesthesia.
99 patients were included randomly based on sealed envelope method into three study groups comprising 33 patients in each.
Study Design:  A prospective randomized double blinded clinical study. Inclusion Criteria: 1. Aged between 18 and 60 years 2. ASA Physical status 1, 2 and 3. 3. Patients undergoing elective lower limb long bone orthopaedic surgery under sub arachnoid block. Exclusion Criteria: 1. Patients with ischemic heart disease, neurological or psychiatric disorders, renal or hepatic insufficiency. 2. Pregnant or lactating women. 3. Obese as defined by a BMI of more than 30 kg/m2.  4. Patients on α antagonists.  5. Patients allergic to the medications being used.  6. CNS and local infections.  7. Spine deformities, raised intracranial pressure and progressive neurological disorders. 8. Those parents who refuse consent.
 
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Sampling Procedure:  The study was conducted on patients undergoing elective surgery at SDM College of Medical Sciences and Hospital. All the patients falling under inclusion criteria were numbered and the patients were randomly allocated into either nalbuphine group (Group N), clonidine group (Group C) or control group (Group Z) using sealed envelope technique.
 
Study Instrument: A pre-designed and pre-tested proforma was used to collect information.
 
PRE ANAESTHETIC EXAMINATION AND PREPARATION 
 
All patients underwent a thorough preanaesthetic evaluation. Patients who met inclusion criteria were enrolled for this study. Written informed consent was obtained. 
 
All the patients were kept nil-per-oral overnight and premedicated with oral diazepam 5 mg on the previous night of surgery. No analgesic was given on the day of surgery before taking to OR. At the pre-operative visit, patients were familiarized with the recording of post-operative pain using a 10-cm visual analogue sale (49) anchored at one end by ―no pain at all ―and at the other end by ―worst pain imaginable.―
 
 
PRE-ANAESTHETIC RE-ASSESSMENT  On the day of operation, all the patients were re-assessed in pre-operative anaesthesia room and basal vital data like pulse, blood pressure and SpO2 were recorded.
 
 
 
 
 
 
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METHOD The patients were randomly allocated into nalbuphine group (Group N), Clonidine group (Group C) or control group (Group Z) using sealed envelope technique into three groups of 33 each, which was opened just before shifting the patient to the operation theatre. 1. Group Z: -2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of Normal saline. 2. Group N: - 2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of 0.8 mg nalbuphine. 3. Group C: - 2.6 ml of 0.5% hyperbaric bupivacaine and 0.4 ml of 60 μg clonidine.
 
In the operation theatre, an appropriate i.v. access was secured and i.v fluids started. Standard monitoring with electrocardiogram, noninvasive arterial blood pressure (NIBP) and pulse-oximetry was initiated and baseline values were recorded. The patients were administered 2.6 ml of 0.5% bupivacaine hyperbaric with the adjuvant. The sterile drug solution was prepared by an experienced and trained anesthesiologist, who is not involved in intraoperative and postoperative management. Anaesthesia resident doing the study was blinded for the study drug being injected. Under strict aseptic precautions, the subarachnoid blockade was performed with a 26G Quincke spinal needle in the L3-L4 interspace in sitting position. The preloaded sterile drug solution was injected over 10-15 seconds after confirmation of free aspiration of cerebrospinal fluid (CSF). The time at which the preloaded sterile drug solution was completely injected into the sub-arachnoid space was noted as the zero time of the study and all subsequent measurements were recorded from this point. Following the administration of the subarachnoid block, the patients were made to lie down supine. Sensory testing was done by cold swab method using cotton swab and time taken to reach T10 level noted. Motor block assessed using modified Bromage Score.  The time taken to reach modified Bromage 3 was recorded. Intravenous ephedrine 6 mg was administered if the systolic blood pressure reduction was ≥ 20% of the baseline value or if the MAP was ≤60 mm Hg. Intravenous atropine 0.6 mg administered if the HR was ≤50 bpm. Patients did not receive any additional analgesic in intra-operative period while anxious patients were given intravenous midazolam 1mg. The incidence of any adverse
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effects such as hypotension, bradycardia, shivering, nausea, vomiting, pruritus, respiratory depression and ECG changes were noted. If there was inadequate or failed spinal, the duration of surgery extended more than 120 min or if the patients complains of pain, they were excluded from the study.
 
All the patients were monitored in the post anaesthesia care unit (PACU) for two hours. In the PACU, inj.Diclofenac 75 mg i.v was administered if the patient complained of pain and had visual analogue scale ≥5. Second line of analgesic inj.tramadol 50 mg slow i.v was administered, if VAS scale did not come below 3, after 30 min administration of inj.Diclofenac 75 mg. If any nausea or vomiting, treated with IV ondansetron 4 mg 
 
Post-operatively, various haemodynamic variables, oxygen saturation and various scores were recorded by a trained attending nurse in the PACU blinded to the injected adjuvant, until complete recovery of the patients from sub-arachnoid blockade.
 
After SAB, vital parameters - heart rate, SBP, DBP, MAP, and use of ephedrine, atropine were recorded and documented during the first 120 min at intervals of 1min, 3min, 5min, 10min, 15min,20min, 30min,45min,60min,75min,90min,105min, and 120min .
 
Post operative pain assessment done at the intervals of 4th h, 8th h, 16th h, & 24th h.
 
Duration of analgesia was taken from the time of intrathecal drug administration to the first supplementation of rescue analgesic when the patient complained of pain or visual analogue scale ≥5. 
 
Definitions of various parameters studied
 
Time of onset of sensory block: It is defined as time taken from the completion of the injection of the study drug till the patient does not feel the pin prick at T10 level.
 
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Time taken for highest level of sensory block: It is defined as the time from the completion of the injection of the study drug to the maximum sensory blockade attained.
 
Time for two segment sensory regression: It is the time from maximum attainment of sensory block to regression of blockade by two segments Total duration of analgesia: It is the time from drug injection to first request for analgesics. Time of onset of grade III motor blockade: is defined as the time taken from the completion of injection of the study drug till patient develops Bromage-scale 3 Total duration of motor blockade: is the time taken from the time of injection till the patient attains complete motor recovery, Bromage- scale 0.
 
 
 
 
 
 
 
 
 

 
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