| CTRI Number |
CTRI/2017/08/009287 [Registered on: 08/08/2017] Trial Registered Prospectively |
| Last Modified On: |
07/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different doses of a combination of two drugs when injected in abdominal wall(rectus sheath) for post operative pain relief in surgeries requiring midline incision.
|
|
Scientific Title of Study
|
Comparative analgesic potency of ropivacaine0.2% versus 0.5% with dexmedetomidine as an adjuvant in preincision USG rectus sheath block for midline incision
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Sharma |
| Designation |
Assistant professor |
| Affiliation |
Dr Rajendra Prasad Govt. Medical College Tanda at Kangra |
| Address |
Department of Anaesthesia; Dr Rajendra Prasad Govt. Medical College Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418011121 |
| Fax |
|
| Email |
shalini.medico@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini Sharma |
| Designation |
Assistant professor |
| Affiliation |
Dr Rajendra Prasad Govt. Medical College Tanda at Kangra |
| Address |
Department of Anaesthesia;
Dr Rajendra Prasad Govt. Medical College Tanda Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418011121 |
| Fax |
|
| Email |
shalini.medico@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalini Sharma |
| Designation |
Assistant professor |
| Affiliation |
Dr Rajendra Prasad Govt. Medical College Tanda at Kangra |
| Address |
Department of Anaesthesia;
Dr Rajendra Prasad Govt. Medical College Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418011121 |
| Fax |
|
| Email |
shalini.medico@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shalini Sharma |
| Address |
Department of Anaesthesia; DRPGMC Tanda; Kangra |
| 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 |
| Shalini Sharma |
DRPGMC Tanda |
Deptt. of Anaesthesia;
Dr Rajendra Prasad Govt. Medical College Tanda
Kangra
HIMACHAL PRADESH |
9418011121
shalini.medico@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient posted for emergency surgery for duodenal ulcer perforation., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Ropivacaine 0.25% (15 ml)with dexmedetomidine 1mcg per kg. |
USG guided bilateral rectus sheath block with a total volume of 17ml on each side. |
| Intervention |
Ropivacaine 0.5% (15 ml)with dexmedetomidine 1mcg per kg. |
USG guided bilateral rectus sheath block with a total volume of 17ml on each side. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA 1 and 2 patients.
2)BMI 18.5-39.9.
3)Patients scheduled for emergency laparotomy for duodenal ulcer perforations.
|
|
| ExclusionCriteria |
| Details |
1)Patient refusal.
2)Bleeding and coagulation disorders.
3)Local infection at the block site.
4)Allergy to study drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of post op analgesia after giving equal volumes and different concentration of ropivacaine 0.25% and 0.5% with dexmeditomidine 1mcg per kg in USG guided rectus sheath block. |
Every 30 min till pain starts. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient satisfaction with pain control.
Number of a rescue analgesic requirement in 24 hours.
|
After 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/08/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study will be conducted at Dr. Rajendra Prasad Govt. medical college Tanda. The patients with perforated duodenal ulcer posted for emergency surgeries and requiring midline incision will be inducted in the study. These patients will be given rectus sheath block after induction with two different doses of dexmedetomidine in combination with ropivacaine on both sides. Duration of analgesia will be assessed in the post operative period. |