| CTRI Number |
CTRI/2016/08/007217 [Registered on: 23/08/2016] Trial Registered Retrospectively |
| Last Modified On: |
14/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the pain relief effect of two types of pain killers in patients of hernia surgery |
|
Scientific Title of Study
|
Comparative study of analgesic efficacy and tolerability of oral tapentadol-paracetamol combination vs. oral tramadol-paracetamol combination for postoperative pain relief in patients undergoing hernia surgery |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukanya Mitra |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesia and Intensive care Government Medical College and Hospital sector 32 |
| Address |
Department of Anaesthesia and Intensive care
Government Medical College and Hospital sector 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
09646121521 |
| Fax |
|
| Email |
drsmitra12@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vanita Ahuja |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anaesthesia and Intensive care Government Medical College and Hospital sector 32 |
| Address |
Department of Anaesthesia and Intensive care
Government Medical College and Hospital sector 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
vanitaanupam@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vanita Ahuja |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anaesthesia and Intensive care Government Medical College and Hospital sector 32 |
| Address |
Department of Anaesthesia and Intensive care
Government Medical College and Hospital sector 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
vanitaanupam@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Government Medical College and Hospital sector 32 Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Anaesthesia and Intensive care |
GMCH sector 32 Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sukanya Mitra |
Department of Anaesthesia and Intensive Care |
Government Medical College and Hospital sector 32
Chandigarh
CHANDIGARH |
09646121521
drsmitra12@yahoo.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
Modification(s)
|
| Health Type |
Condition |
| Patients |
Male patients
18 to 70 years
Inguinal Hernia Surgery
ASA 1 and 2 status, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Tapentadol and paracetamol |
In patients following hernia surgery, when the level of subarachnoid block will recede to T10 then patients will receive combination of oral tapentadol 100mg and oral paracetamol 500mg and repeated every 6-hourly thereafter up to 24 hours postoperatively. |
| Comparator Agent |
Oral Tramadol and Paracetamol |
In patients following hernia surgery, when the level of subarachnoid block will recede to T10 then patients will receive combination of oral tramadol 100mg and oral paracetamol 500mg and repeated every 6-hourly thereafter up to 24 hours postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Under going inguinal hernia surgery
ASA status I and II |
|
| ExclusionCriteria |
| Details |
1. ASA status > III
2. Major co-existing medical illness (especially severe asthma/COPD, epilepsy, uncontrolled hypertension or diabetes, liver or renal disease)
3. Patients with paralytic ileus
4. Patients on tricyclic antidepressants, anticonvulsants, Mono amino oxidase inhibitors, antipsychotics or serotonin-norepinephrine reuptake inhibitors (i.e. within 30 days)
5. Known hypersensitivity to any of the study medications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain at rest and on movement measured by visual analog scale (VAS) |
During the postoperative period at intervals of 0 hour (when the first dose of the combination is administered, i.e., when the block level recedes to T10), 2, 4, 8, 12, and 24 h |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamics,Patient Satisfaction Scale , rescue analgesics, adverse effects |
During the postoperative period at intervals of 0 hour (when the first dose of the combination is administered, i.e., when the block level recedes to T10), 2, 4, 8, 12, and 24 h |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Pain after surgery is inevitable and if not adequately controlled
can adversely affect both physical and physiological functions. Inadequate
relief of postoperative pain can prolong recovery, increase the duration of
stay in the hospital and increase health care costs. Unrelieved
acute pain is often associated with sleeplessness, anxiety, fear, or
demoralization and may lead to the development of chronic pain syndromes. Effective pain management
is an important component of post-surgical care. The latest innovation in this class of compounds with the novel
mechanism of action is tapentadol. Tapentadol shares the same dual-action
mechanism as tramadol, but is devoid of the the disadvantages of tramadol
mentioned. Thus, it represents a theoretical and practical advancement in
pain management.To the best of our knowledge, so far there are
no studies comparing the analgesic efficacy and tolerability of oral
tapentadol-paracetamol combination vs. oral tramadol-paracetamol combination
for postoperative pain relief in patients undergoing hernia surgery
|