| CTRI Number |
CTRI/2024/08/071886 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Postoperative pain management in hysterectomy patient |
|
Scientific Title of Study
|
Postoperative quality of recovery after hysterectomy in patient on Duloxetine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kashmla Khan |
| Designation |
Postgraduate |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology Kasturba medical college, light house hill road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7587471463 |
| Fax |
|
| Email |
kashmla.kmcmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumesh T Rao |
| Designation |
Professor and head of department |
| Affiliation |
kasturba medical college, mangalore |
| Address |
Department of Anaesthesiology Kasturba medical college, light house hill road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9449167895 |
| Fax |
|
| Email |
sumesh.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumesh T Rao |
| Designation |
Professor and head of department |
| Affiliation |
kasturba medical college, mangalore |
| Address |
Department of Anaesthesiology Kasturba medical college, light house hill road Mangalore
KARNATAKA
575001
India |
| Phone |
9449167895 |
| Fax |
|
| Email |
sumesh.rao@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Light House Hill Road, Mangalore, Karnataka 575001
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Light House Hill Road Mangalore Karnataka 575001 |
| Type of Sponsor |
Private 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 Kashmla Khan |
Kasturba Medical College Mangalore |
Department of Anaesthesiology Kasturba Medical College, Light House Hill Road Mangalore
Dakshina Kannada
KARNATAKA |
7587471463
kashmla.kmcmlr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Kasturba medical college mangalore |
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 |
| Comparator Agent |
Control
(Group C) |
Total participants in this group:31
These candidates will not receive Tab Duloxetine 2hours before the surgery and 24hours after the surgery.
Total duration: 6 months The Surgical team will be blinded to group allocation |
| Comparator Agent |
Duloxetine
(Group D) |
Total participants :31
Tab Duloxetine 60mg to be given per orally with 2 sips of water 2hours before the surgery and 24 hours after the surgery
Total duration: 6 months
The Surgical team will be blinded to group allocation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with benign gynaecologic conditions (fibroids, pelvic pain, uterine prolapse)
who are planned to undergo hysterectomy under spinal anaesthesia.
2. Female patients older than 18 years with ASA I or II. |
|
| ExclusionCriteria |
| Details |
1. Patients with chronic non-gynaecologic conditions (liver or pulmonary disease,
diabetes mellitus)
2. The history of use of psychotropic drugs (anti-depressants, neuroleptics, lithium) in
the last 1 year.
3. Those with Duloxetine allergy.
4. Patients using opioids for gynaecologic or non-gynaecologic conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Quality of Recovery-40
questionnaire total score
2. Visual Analogue score |
Both the respective Groups will be assessed Postoperatively at 6th, 12th and 24th hours after the surgery.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Opioid analgesic consumption
doses (Fentanyl)
2. Adverse Events |
1. Opioid analgesic consumption (fentanyl)
doses 24 hours after surgery
2. Adverse Events During stay
in postoperative ward at 48 hours |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
15/08/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sumesh.rao@manipal.edu].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Postoperative pain is one of the main issues in postoperative care and plays an important role in accelerating the improvement of surgical patient’s general condition 1 . Female patients have worse quality of recovery after surgery than male patients. The greater propensity for pain and opioid-related side effects are likely contributing factors for poor postsurgical recovery in women. Hysterectomy is a commonly performed surgical procedure in women, and it often results in significant pain and slow recovery 2 . One of the strategies to prevent chronic postoperative pain is to reduce the acute pain in the initial phase using effective medications with the least side effects. Nevertheless, pharmacologic strategies to improve global quality of recovery after hysterectomy have yet to be examined 2 . In this study, we intended to evaluate the effect of perioperative administration of oral Duloxetine on postoperative pain and recovery in patients undergoing hysterectomy.
Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) commonly used to treat depression, anxiety and chronic pain. The medication works by increasing the levels of serotonin and norepinephrine in the brain, which can help to reduce pain, improve mood and promote relaxation. Duloxetine has also been found to have a mild analgesic effect and has been investigated as a premedication for various surgical procedures, including hysterectomy. Duloxetine premedication in hysterectomy effectively reduces pain and improves patient satisfaction. Duloxetine has been shown to improve the quality of anaesthesia, reduce the need for additional pain medication and cause lesser adverse events when compared to those who do not receive premedication.
This study aims to investigate the efficacy and safety of perioperative oral Duloxetine on quality of recovery and as an analgesia in adult patients undergoing hysterectomy and the Quality of Recovery-40 questionnaire (QoR-40) shall be used for evaluation. |