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
|
|
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
|
|
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. |