| 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
|
|
|
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
|
|
|
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. |