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CTRI Number  CTRI/2018/08/015463 [Registered on: 24/08/2018] Trial Registered Prospectively
Last Modified On: 24/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Does pouring of local anaesthetics and adding dexmedetomidine in local anaesthetics drop by drop over incision wound prevent post surgical pain in patients who had lower spine surgery. 
Scientific Title of Study   Post-Operative Analgesic Effect of Bupivacaine alone and with Dexmedetomidine in Wound Instillation for Lumbar Laminectomy: A Randomised Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Urvashi Yadav 
Designation  Associate Professor 
Affiliation  U.P.U.M.S, Saifai 
Address  Department of Anaesthesia, UPUMS,Saifai
205 S.R Hostel,New Doctors Campus UPUMS,Saifai
Etawah
UTTAR PRADESH
206130
India 
Phone  07500186161  
Fax    
Email  drurvikgmu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Urvashi Yadav 
Designation  Associate Professor 
Affiliation  U.P.U.M.S, Saifai 
Address  Department of Anaesthesia, UPUMS,Saifai.
205 S.R Hostel,New Doctors Campus, UPUMS,Saifai
Etawah
UTTAR PRADESH
206130
India 
Phone  07500186161  
Fax    
Email  drurvikgmu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Urvashi Yadav 
Designation  Associate Professor 
Affiliation  U.P.U.M.S, Saifai 
Address  Department of Anaesthesia, UPUMS,Saifai.
205 S.R Hostel,New Doctors Campus, UPUMS,Saifai
Etawah
UTTAR PRADESH
206130
India 
Phone  07500186161  
Fax    
Email  drurvikgmu@gmail.com  
 
Source of Monetary or Material Support  
3rd Floor, Old Building, Department of anaesthesia,U.P.U.M.S, Saifai 
 
Primary Sponsor  
Name  Department of Anaesthesia 
Address  U.P.U.M.S, Saifai (U.P) 
Type of Sponsor  Research institution and hospital 
 
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 
Urvashi Yadav  U.P.U.M.S  3rd Floor, old building,Department of Anaesthesia ,Saifai(U.P)206130
Etawah
UTTAR PRADESH 
07500186161

drurvikgmu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients of age group 18 to 60 yrs with ASA 1 or 2, planned for lumbar laminectomy under general anaesthesia.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  bupivacaine drug dexmedetomidine drug  bupivacaine is a local anaesthetic agent and dexmedetomidine is an alpha2 agonist which potentiates the effect of local anaesthetics. 
Comparator Agent  Normal Saline 20 ml  control group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA physical status I and II.
2. Age 18 to 60yrs of either sex,
3. Scheduled for lumbar laminectomy under general anaesthesia
 
 
ExclusionCriteria 
Details  1.Patients with spinal stenosis,
2.Planned to have multiple level or double site laminectomy,
3.Patients who underwent prior lumbar disc surgery,
4.Have ASA III-IV status,
5.Prior neurological deficits,
6.Preoperative opioid use or any history of substance abuse or on steroids,
7.Have known local anaesthetics allergy,
8.Bleeding, cerebrospinal fluid leak, or requiring placement of a drain.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
. post operative pain score.
Duration of analgesia, total analgesic requirement and pain score in 24 hours will be recorded. 
0 hr ,every 1 h till 8 hrs and then every 6 hrs till 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
vital parameters of patients.
side effects if any 
up to 24 hrs. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/09/2018 
Date of Study Completion (India) 30/03/2019 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
published in Anaesthesia essays and researches Year 2020 , Volume 14,Issue 1, page 149-153. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Background: Dexmedetomidine has been used as an effective adjuvant to local anaesthetics in peripheral nerve blocks and at incision site. We studied the effect of addition of dexmedetomidine as an adjuvant to bupivacaine in wound instillation for postoperative analgesia. Aims To compare the postoperative analgesic effect of bupivacaine alone and in addition of dexmedetomidine to bupivacaine in wound instillation for lumbar laminectomy.

Study Design: Prospective, randomised, double blind study.

Methodology: Sixty adults of ASA grade I-II scheduled for elective lumbar laminectomy under general anaesthesia were randomly allocated into two groups. Group B(control group) patients received wound instillation with 20ml of 0.25% bupivacaine at the end of surgery and Group D patients received 2μgm.kg-1dexmedetomidine diluted in 20 ml 0.25% bupivacaine as instillation over incision site. If the NRS exceeded ‘4’ at any point of time, rescue analgesia with inj. Diclofenac 75 mg deep intramuscular was administered. Post- operative pain score, duration of analgesia, total rescue analgesic required in 24 h, incidence of side effects such as bradycardia, hypotension, sedation, nausea and vomiting were compared between the groups.

Results: Dexmedetomidine group has better pain score, longer duration of effective analgesia, lower percentage of patients requiring rescue analgesic and less no of doses of rescue analgesic required in first 24 h.

Conclusion: We conclude that dexmedetomidine 2µg.kg-1 is an effective adjuvant to bupivacaine for wound instillation in terms of quality and duration of postoperative analgesia following lumbar laminectomy.

 
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