| CTRI Number |
CTRI/2025/07/091884 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Recovery Pain After Laparoscopic Hysterectomy: Women With Diabetes versus Without Diabetes
|
|
Scientific Title of Study
|
Comparision of Post-operative pain using VAS and Analgesia requirement among Diabetic and Non-Diabetic patients undergoing Total Laparoscopic Hysterectomy Surgery. A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pandya Niyati Narendrabhai |
| Designation |
Anaesthesiologist |
| Affiliation |
All India Institute of Medical Sciences, Rajkot.. |
| Address |
Satyam Park, Block N0. 08, Near Indian Park Avas Yojana, Raiya Road.
Rajkot
GUJARAT
360005
India |
| Phone |
9427410422 |
| Fax |
|
| Email |
niyatipandya9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pandya Niyati Narendrabhai |
| Designation |
Anaesthesiologist |
| Affiliation |
All India Institute of Medical Sciences, Rajkot. |
| Address |
Satyam Park, Block No. 08, Near Indian Park Avas Yojana, Raiya Road.
Rajkot
GUJARAT
360005
India |
| Phone |
9427410422 |
| Fax |
|
| Email |
niyatipandya9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pandya Niyati Narendrabhai |
| Designation |
Anaesthesiologist |
| Affiliation |
All India Institute of Medical Sciences, Rajkot. |
| Address |
Satyam Park, Block No. 08, Near Indian Park Avas Yojana, Raiya Road.
Rajkot
GUJARAT
360005
India |
| Phone |
9427410422 |
| Fax |
|
| Email |
niyatipandya9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, All India Institute of Medical Sciences, Khandheri Parapipaliya, Rajkot. 360006 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences. |
| Address |
Khandheri Parapipaliya, Rajkot. 360006 |
| 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 |
| Pandya Niyati Narendrabhai |
All India Institute of Medical sciences, Rajkot |
Department of Anaesthesiology, All India Instiute of medical sciences Khandheri- Parapipaliya
Rajkot
GUJARAT |
09427410422
niyatipandya9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, All India Institute of Medical Sciences, Rajkot, Gujarat. |
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 |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
- Patients undergoing Total Laparoscopic Hysterectomy during study period.
- Age group: 40-65 years Female
- ASA- I, II, III
- Patients providing informed consent
|
|
| ExclusionCriteria |
| Details |
- Patient refusal
- ASA IV,V
- Patients with psychiatric or neurological disorders who cannot give proper pain assessment
- Patient already on multiple analgesics due to Diabetic Neuropathic Pain
- Patients with kidney diseases or diagnosed diabetic nephropathy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparision of Pain using VAS in Diabetic and Non-Diabetic patients for 24 hours post Total Laparoscopic Hysterectomy Surgery |
VAS assessed every 2 hourly for 24 hours post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of the effect of Glycosylated Haemoglobin (HbA1c) on Post-opeative Pain.
Comparision of the time of first Rescue Analgesia required within 24 hrs post-operatively in Diabetic vs Non-Diabetic patients.
Comparision of the frequency of Rescue Analgesia required within 24 hrs post-operatively in Diabetic vs Non-Diabetic patients.
Observation of post-operative complications (if any) in 24 hours after the surgery.
Assessment of Wilson sedation scale,
Patient’s overall satisfaction with Linkert 5 point scale
|
All parameters are measured for 24 hours post-surgery. |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
15/08/2025 |
| 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
|
Group N is Non Diabetic Patients
Group D is Diabetic Patients
All Patients to be subjected to
complete Pre-anaesthetic checkup. In Diabetic patients, Type of Diabetes,
Duration of disease, Present Status of Disease, Complications (if any) to be recorded.
All Patients to be subjected to
routine investigations. Glycosylated Haemoglobin (HbA1c) to be done in all
patients included in the study.
Patients on OHA were shifted
to Inj. Regular Insulin peri-operatively according to physicians advice.
Patients were kept NPO as per
guidelines.
On arrival in OT,
Intravenous access is
established with 20G IV Cannula. Inj RL started at the rate of 80ml per hour.
Standard monitors with pulse
oximeter, NIBP, ECG , End tidal carbon di oxide line attached and parameters noted.
After pre-oxygenation with
100 percentage oxygen, GA to be administered with Inj Fentanyl 2mcg per kg, Inj Propofol 1.5
mg per kg, Inj Rocuronium 0.6 mg per kg after checking proper mask ventilation.
Tracheal intubation to be done with proper sized cuffed Endotracheal tube.
Position of the Surgery to be
given and ventilated accordingly.
Maintanance of anaesthesia
done with Isoflurane, Intermittent doses Inj.Rocuronium 0.2mg per kg, Inj Fentanyl
1mcg per kg.
Inj Paracetamol 15mg per kg to be
given 30 min before extubation.
After closure, local site
infiltration with Inj. Bupivacaine (0.25 percentage) to be done at incision sites (2 to 3ml
at each site).
Reversal with Inj Neostigmine
0.05 mg per kg with glycopyrolate 0.01mg per kg after noting appropriate Train Of Four
response and extubation to be done.
Patients will be Shifted to
post-Operative Care unit. Patients will be assessed 2nd hourly on
following parameters for 24 hours.
-
Visual
analogue scale (VAS)
-
Rescue
analgesia requirement
-
Wilson
sedation scale
-
Patient’s
overall satisfaction with Linkert 5 point scale
-
Time of
earliest mobilization
-
Complications
(if any)
Post operatively Inj
Paracetamol 1 gm IV to be given QID
Inj Diclofenac 75mg IV to be
given as rescue analgesia.
Rescue analgesia medication to
be given every time VAS more than or equal to 4 and noted. |