| CTRI Number |
CTRI/2025/03/081770 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Patient satisfaction after abdominal surgery |
|
Scientific Title of Study
|
Comparison of patient satisfaction during abdominal hysterectomy surgeries using isobaric segmental spinal anesthesia versus hyperbaric spinal anesthesia |
| 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 CH Rama Krishna Prasad |
| Designation |
Associate professor |
| Affiliation |
All India Institute of medical sciences,Bibinagar |
| Address |
Department of Anesthesiology, All India Institute of Medical Sciences, Bibinagar,Hyderabad Metropolitan Region, Telangana
Hyderabad
TELANGANA
508126
India |
| Phone |
9885718133 |
| Fax |
|
| Email |
ramakrishna.chikkala19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep G |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
Department of Anesthesiology, All India Institute of Medical Sciences, Bibinagar,Hyderabad Metropolitan Region, Telanagana
Hyderabad
TELANGANA
508126
India |
| Phone |
9989421851 |
| Fax |
|
| Email |
drsandeep189@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep G |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
Department of Anesthesiology, All India Institute of Medical Sciences, Bibinagar,Hyderabad Metropolitan Region, Telanagana
Hyderabad
TELANGANA
508126
India |
| Phone |
9989421851 |
| Fax |
|
| Email |
drsandeep189@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bibinagar, HYDERABAD, TELANGANA, INDIA. PIN:508126 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences,Bibinagar,Hyderabad Metropolitan Region,Telangana,INDIA, pin:508126 |
| 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 CH Rama Krishna Prasad |
All India Institute of Medical Sciences, Bibinagar |
Room number G35 and G36, Operation Theater Complex, Department of Anesthesiology,All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan region, Telangana
508126
Nalgonda
TELANGANA |
9885718133
ramakrishna.chikkala19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(AIIMS BBN-IEC) |
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 |
Routine spinal anesthesia for abdominal hysterectomy |
Spinal anesthesia will be performed at L3-L4 intervertebral level using a 25G quincke needle with 15mg of hyperbaric levobupivacaine and 25mcg fentanyl
duration will be 5 min |
| Intervention |
Segmental spinal anesthesia for abdominal hysterectomy |
Segmental spinal anesthesia will be performed at T9-T10 intervertebral level using 25G Whitacre needle with 10mg isobaric levobupivacaine and 25mcg fentanyl.
duration will be 5 mins for the procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA I,II
Abdominal Hysterectomy surgeries |
|
| ExclusionCriteria |
| Details |
Known allergy to the test drugs
Hepatic,renal disease
Chronic alcoholic
Suffering from any other chronic pain syndrome
Surgeries with expected duration more than 3hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction score |
Patient satisfaction score will be assessed at 6hrs and 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of cardiorespiratory parameters
2.Residual analgesic effect:Time from puncture till patient asks for rescue analgesic |
1.Blood pressure(systolic, diastolic, mean), heart rate and oxygen saturation (spO2) will be evaluated every 3minutes up to 15minutes and then every 5minutes till end of surgery
2.Pain will be assessed using visual analogue score every hour in the postoperative period
|
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
25/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Regional Anesthesia is preferred mode of anesthesia for lower abdominal procedures. Spinal anesthesia can be performed with hyperbaric and isobaric solution in lower abdominal procedures. Isobaric segmental spinal anesthesia due to its baricity spreads less and will block a few dermatomes compared to hyperbaric which will spread more caudad in view of gravity. Compared to hyperbaric, isobaric will provide more dense motor block with advantage of less cephalad spread and sparing of caudal regions and early postoperative mobility. We hypothesize that isobaric segmental spinal provide better post operative recovery, stable hemodynamics compared to hyperbaric bupivacaine in patients undergoing total abdominal hysterectomy . In this study we aim to evaluate the hemodynamic, patient and surgeon satisfaction score in isobaric versus hyperbaric segmental spinal anesthesia. |