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CTRI Number  CTRI/2018/04/012976 [Registered on: 03/04/2018] Trial Registered Retrospectively
Last Modified On: 03/04/2018
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   A comparison between two different drugs for spinal anaesthesia in knee surgery. 
Scientific Title of Study   A randomized comparative study to evaluate the efficacy of intrathecal isobaric ropivacaine and bupivacaine in patients undergoing arthroscopic knee surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suresh Kumar S 
Designation  Consultant (current designation), Post graduate (previous designation) 
Affiliation  VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL (STUDY WAS DONE HERE) 
Address  Vardhman Mahavir Medical College and Safdarjung hospital, Ring road, Ansari nagar west, New Delhi

New Delhi
DELHI
110029
India 
Phone  9999942084  
Fax    
Email  surkum85@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vandana Talwar Guide  
Designation  Professor 
Affiliation  VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL (STUDY WAS DONE HERE) 
Address  Main OT block, Vardhman Mahavir Medical College and Safdarjung hospital, Ring Road, Ansari nagar west, New Delhi

New Delhi
DELHI
110029
India 
Phone  9811352251  
Fax    
Email  drvandanatalwar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suresh Kumar S 
Designation  Consultant (Current designation), Post graduate (Previous designation) 
Affiliation  VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL (STUDY WAS DONE HERE) 
Address  Main OT block, Vardhman Mahavir Medical college and Safdarjung hospital, Ring Road, Ansari nagar west, New Delhi

New Delhi
DELHI
110029
India 
Phone  9999942084  
Fax    
Email  surkum85@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical college and Safdarjung hospital, Ring Road, Ansari Nagar West, New Delhi 110029 
 
Primary Sponsor  
Name  Dr Suresh Kumar S 
Address  Vardhman Mahavir Medical college and Safdarjung hospital, Ring road, Ansari nagar West, New Delhi 110029. 
Type of Sponsor  Other [Self] 
 
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 
Dr Suresh Kumar S  Vardhman Mahavir Medical college and Safdarjung hospital  Department of Anaesthesia and Intensive care unit, OT Block, Ring Road, Ansari Nagar West, New Delhi 110029
New Delhi
DELHI 
9999942084

surkum85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee/ Ethics Sub-Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with conditions (ACL/PCL tear/meniscus tear) that require arthroscopic knee surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Isobaric Bupivacaine  Single dose of 2 ml of 0.5% Bupivacaine injected into intrathecal space before the beginning of surgery.  
Intervention  Isobaric Ropivacaine  Single dose of 2 ml of 0.75% Ropivacaine injected into intrathecal space before the beginning of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Ninety adult patients scheduled to undergo elective knee arthroscopy.
2.Weight between 50-75 kg.
3.Height ranging from 150-180 cm.  
 
ExclusionCriteria 
Details  1. Patients who are unable to understand the procedure.
2. Patients with refusal to spinal anaesthesia 3. Presence of local site infection.
4. Patients with coagulation abnormalities.
5. Patients with history of allergic reaction to any of the drugs.
6. Patients with sepsis.
7. Patients with spinal deformity or previous spinal surgery.
8. Patients with neurological disturbances.
 
 
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 
1. To compare the efficacy and duration of motor block and sensory block between the two drugs.
2.To assess the post operative recovery profile and readiness for discharge in both the groups. 
1. Motor block was assessed by Modified Bromage Scale (1-6). Sensory block was assessed by loss of sensation to pin prick. Both the blocks were assessed every 2 minutes till two consecutive readings remained the same, after which it was assessed every 10 minutes till the end of surgery. After the surgery block was assessed half hourly till complete regression of block.
2.Post operatively patients were assessed half hourly by Post Anaesthetic Discharge Scoring System until the score reaches 9. 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative pain and analgesia
 
Visual analogue scale (0-10) was used to assess the post-operative pain at rest and during passive movements at 0, 1, 2, 4, 6 hrs after surgery.  
Post operative complications such as pain, nausea, vomiting, headache, backache, hypotension, delayed voiding and transient neurologic symptoms.  All the patients were assessed after 24 hrs of surgery for post operative complications. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/09/2009 
Date of Study Completion (India) 22/09/2010 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Background: The primary goal of ambulatory anaesthesia is rapid recovery leading to early patient discharge with minimal side effects. Ropivacaine, due to its property of sensory-motor dissociation, may be a potentially useful agent when an equivalent spinal anaesthesia and quicker recovery of motor function is desirable. The main objective of our study was to compare 0.75% intrathecal isobaric ropivacaine (15mg) and 0.5% intrathecal isobaric bupivacaine (10mg) to assess the efficacy of anaesthesia, analgesia, postoperative recovery profile and readiness for discharge in patients undergoing arthroscopic knee surgery.

 

Materials and methods: 90 adult ASA grade 1 and 2 patients were randomized into two groups to receive 2 ml plain solution of either 0.5% bupivacaine (Group B) or 0.75 % ropivacaine (Group R). In the intraoperative period, onset, efficacy, duration and regression of sensory and motor block were noted in both the groups at regular intervals. Postoperatively, the groups were compared for pain score using the visual analog scale (VAS), recovery profile using post anaesthetic discharge scoring system (PADSS), analgesic requirement and complications.

 

Results:  The mean time of onset of sensory block at L1 was significantly less (p=0.025) and duration of sensory (284.64 vs 257.57 mins) and motor block (250.07 vs 222.11 mins) was significantly more (p=0.001) with bupivacaine as compared to ropivacaine. Maximum upper level of sensory block was at T8 in both the groups, and the number of patients who attained this block was significantly more with bupivacaine (37.4% vs 22%, p=0.017). The number of patients who required 2 analgesic doses on the first postoperative day (33.3% vs 11.1%, p=0.011) and incidence of delayed voiding of urine (13.33% vs 0; p = 0.022) was significantly more with ropivacaine. There was no difference in postoperative recovery profile and discharge times between the groups.

 

Conclusions: Isobaric bupivacaine provides a shorter onset and longer duration of sensory block, decreased postoperative analgesic requirement and lesser complication rate as compared with isobaric ropivacaine. Though, isobaric ropivacaine is associated with a shorter duration of motor block, postoperative recovery profile and discharge time between the groups was similar. Therefore, isobaric bupivacaine should be preferred over isobaric ropivacaine for day care knee arthroscopy, especially in cases with anticipated longer duration of surgery.

 
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