| CTRI Number |
CTRI/2025/11/096958 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of morphine given during spinal anesthesia in participants undergoing laproscopic hyserectomy to see quality of recovery as the main outcome |
|
Scientific Title of Study
|
Effect of Intrathecal Morphine on Quality of Recovery of Patients
Undergoing Laparoscopic Assisted Hysterectomy: A Randomized
Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHAVYA PURI |
| Designation |
MD RESIDENT ANESTHESIA |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Junior Resident Department Of Anesthesia And Intensive Care 4th Floor Nehru Complex PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
07807304483 |
| Fax |
|
| Email |
drbhavyapuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RASHI SARNA |
| Designation |
ASSOCIATE PROFESSOR ANESTHSIA AND INTENSIVE CARE |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Department Of Anesthsia And Intenisive Care 4th Floor A Block Nehru Building PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9646002284 |
| Fax |
|
| Email |
sarnarashi@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR RASHI SARNA |
| Designation |
ASSOCIATE PROFESSOR ANESTHSIA AND INTENSIVE CARE |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Department Of Anesthsia And Intenisive Care 4th Floor A Block Nehru Building PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9646002284 |
| Fax |
|
| Email |
sarnarashi@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department Of Anesthsia And Intenisive Care 4th Floor A Block Nehru Building PGIMER Chandigarh INDIA PIN 160012 |
|
|
Primary Sponsor
|
| Name |
BHAVYA PURI |
| Address |
Junior Resident Department Of Anesthesia And Intensive Care 4th Floor Nehru Complex PGIMER Chandigarh |
| 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 |
| DR BHAVYA PURI |
PGIMER CHANDIGARH |
GYANECOLOGY OPERATION THEATER MAIN OT COMPLEX 4 FLOOR A BLOCK PGIMER CHANDIGARH
Chandigarh
CHANDIGARH |
07807304483
drbhavyapuri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intrathecal morphine |
Intrathecal morphine injection will be given to the case groups at 200micrograms or 0.3 micrograms per KG whichever is lower and compared with the control group |
| Comparator Agent |
SHAMS procedure |
In the control group only local infiltration with local anesthic will be done after part preparation with chlorhexidine solution and using a capped syringe pressure will be applied for two minutes without puncturing the dura and no intrathecal drug will be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Female patients aged more than18 years up to 70 years
ASA physical status I to ASAIII
Patient scheduled for elective laparoscopic hysterectomy
Ability to understand and complete the QoR-15 questionnaire
|
|
| ExclusionCriteria |
| Details |
Declined consent to participate
Contraindication to intrathecal morphine
Morbid obesity BMI more than 35 kg per m2
History of chronic opioid use or opioid dependence
Severe hepatic, renal, or respiratory disease
Contraindications to neuraxial anesthesia
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of implementing ITM on QOR of patients undergoing laparoscopic-assisted hysterectomy between 18 to 70 years of age. |
pod 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of recovery score on POD 2 and 3
|
pod 2 pod 3 |
To compare post-operative pain scores between both groups.
|
|
| To compare post-operative analgesia/ IV-opioid requirement in both groups. |
|
| To assess adverse effects related to the administration of intrathecal morphine |
|
| To assess the difference in length of hospital stay and overall patient satisfaction |
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
16/11/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We hypothesize that patients
receiving intrathecal morphine will have significantly improved quality of
recovery, compared to those receiving standard analgesia following
laparoscopic-assisted hysterectomy.Aim of study To assess the impact of implementing ITM on QOR of
patients undergoing laparoscopic-assisted hysterectomy between
18 to 70 years of age.
Primary objective Quality of recovery score on Postoperative Day 1.
Secondary objectives
Quality
of recovery score on POD 2 and To compare post-operative pain
scores between both groups.
To compare post-operative analgesiaand IVopioid requirement in both groups.
To assess adverse effects related
to the administration of intrathecal morphine To assess the difference in
length of hospital stay and overall patient satisfaction
|