| CTRI Number |
CTRI/2019/05/019039 [Registered on: 10/05/2019] Trial Registered Prospectively |
| Last Modified On: |
10/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
2 drugs are used to compare the pain relieving ability after operation by using interpleural block in patients undergoing breast surgeries |
|
Scientific Title of Study
|
A comparison of Ropivacaine alone and with morphine for postoperative analgesia using interpleural block for patients undergoing breast surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MANOJ KUMAR S K |
| Designation |
POST GRADUATE |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, GROUND FLOOR, MAIN OT BUILDING, VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL,NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
8197141299 |
| Fax |
|
| Email |
manojkumar12384@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANOOP RAJ GOGIA |
| Designation |
PROFESSOR AND CONSULTANT |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, GROUND FLOOR, MAIN OT BUILDING, VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL,NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9810318291 |
| Fax |
|
| Email |
gogiaanoop@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANOOP RAJ GOGIA |
| Designation |
PROFESSOR AND CONSULTANT |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, GROUND FLOOR, MAIN OT BUILDING, VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL,NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9810318291 |
| Fax |
|
| Email |
gogiaanoop@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive care , ground floor , main ot building, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi ,110029 |
| Type of Sponsor |
Government medical college |
|
|
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 MANOJ KUMAR S K |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, GROUND FLOOR, MAIN OT BUILDING, VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL,NEW DELHI
New Delhi
DELHI |
8197141299
manojkumar12384@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interpleural block with ropivacaine alone |
Patients in this group will provided with general anaesthesia and interpleural block given in 3rd intercostal space along midaxillary line with 20ml of 0.5% ropivacaine given using saline infusion technique after negative aspiration for blood. Intra operative parameters like heart rate, blood pressure,spo2, etco2, and additional intra operative analgesic requirement will be noted. In case of more than 20% increase in baseline haemodynamic parameters ,a repeat dose of inj.fentanyl 1mcg/kg will be given. Post operative pain assessment done by visual analogue scale and verbal rating score at 0hr,1/2 hr,2hr,6hr, 18hr,24hr atrest and during standardised movements. Rescue analgesia is given inj.diclofenac 1.5mg IV and if verbal rating score is more than 4 inj.Tramadol 50mg IV as second rescue analgesia. Total rescue analgesia given are recorded and degree of sedation assessed using Ramsay sedation scale.
Nausea and vomitting also noted. |
| Comparator Agent |
Interpleural block with ropivacaine and morphine |
Patients in this group will be provided with general anaesthesia and interpleural block with 20ml of 0.5% ropivacaine and 3mg morphine given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 1 and 2 scheduled for elective surgery under general anaesthesia for any lesion in the breast benign or malignant |
|
| ExclusionCriteria |
| Details |
1)History of allergy to local anaesthesia
2)Patients with severe renal, hepatic,respiratory, cardiac ,neurologic disorders
3)History of opioid cocaine abuse
4) On anticoagulants
5) Psychiatric illness patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare post operative duration and quality of analgesia amongst patients undergoing breast surgeries using interpleural block with ropivacaine alone and with morphine by using Visual analogue scale , verbal rating scale, modified Ramsay Sedation scale |
In postoperative period 0 hour,1/2 hour,1 hour, 2 hour, 6 hour, 18hour, 24hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study haemodynamic effect to signify the Intra operative analgesia in Interpleural block |
In intra operative period every 10th minute after block till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/05/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg 2000;90:14025.
2) Coveney E, Weltz CR, Greengrass R, Iglehart JD, Leight GS, Steele SM, et al. Use of paravertebral block anesthesia in the surgical management of breast cancer: Experience in 156 cases. Ann Surg 1998;227:496501.
3) Jaffe SM, Campbell P, Bellman M, Baildam A. Postoperative nausea and vomiting in women following breast surgery: An audit. Eur J Anaesthesiol 2000;17:261-4.
4) Boughey JC, Goravanchi F, Parris RN, Kee SS, Kowalski AM, Frenzel JC, et al. Prospective randomized trial of paravertebral block for patients undergoing breast surgery.Am J Surg 2009;198:720-5 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1)To study and compare post-operative duration and quality of analgesia amongst patients undergoing breast surgeries using interpleural block with ropivacaine alone and with morphine. 2)To study haemodynamic effect to signify the intra-operative analgesia in interpleural block in patients undergoing breast surgeries. HYPOTHESIS
Combination of ropivacaine with morphine will provide better post-operative analgesia than ropivacaine alone in interpleural block in patients undergoing breast surgeries |