| CTRI Number |
CTRI/2024/07/071713 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of pain relief after surgery between two techniques of injection in abdominal wall in patients undergoing Laparoscopic gall bladder removal. |
|
Scientific Title of Study
|
Comparison of postoperative analgesia in Ultrasound in Transversus Abdominis Plane block versus Laparoscopy assisted Transversus Abdominis Plane block in Laparoscopic Cholecystectomies in a Tertiary care center. |
| 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 Khyati Modi |
| Designation |
Junior Resident |
| Affiliation |
KMC Manipal |
| Address |
Department of Anaesthesiology KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8962301664 |
| Fax |
|
| Email |
khyatim1497@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rama Rani K |
| Designation |
Associate Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Anaesthesiology KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9902938044 |
| Fax |
|
| Email |
rama.rani@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramyatha Aithal |
| Designation |
Senior Resident |
| Affiliation |
KMC Manipal |
| Address |
Department of Anaesthesiology
KMC Manipal
Udupi
KARNATAKA
57610
India |
| Phone |
9481018932 |
| Fax |
|
| Email |
ramyathaaithal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Kasturba Medical College, MAHE,Manipal,Udupi KARNATAKA 576104 INDIA |
| Department of General Surgery, Kasturba Medical College, MAHE,Manipal,Udupi KARNATAKA 576104 INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [(NA)] |
|
|
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 Khyati Modi |
Kasturba Hospital, Manipal |
Department of Anaesthesiology, Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA |
08962301664
khyatim1497@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College & Kasturba Hospital Institutional Ethics Committee-2EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K80||Cholelithiasis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients undergoing elective laparoscopic cholecystectomy & TAP block as postoperative analgesia.
2) American Society of Anesthesiologists (ASA) physical status classification I-II |
|
| ExclusionCriteria |
| Details |
1) Patient refusal. 2) Patient BMI greater than 35. 3) Patient with history of allergy to the local anesthetic agent used in TAP block. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To compare the time to first rescue analgesic requirement in both the groups.
2) To compare the total requirement of analgesics in the postoperative periods in both the groups. |
In first 24hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of either blocks on postoperative nausea & vomiting & other effects of the block. |
Immediately upon arrival at PACU ,6,12 & 24hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/08/2024 |
| 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 Yet Recruiting |
| 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
|
The postgraduate in anaesthesiology will examine patients on the previous day for eligibility for inclusion in the study and take informed consent from eligible patients. Preoperative orders will be followed as per the consultant anaesthesiologist posted in the operation theater. The postgraduate will also observe the patients postoperatively. Standardized general anaesthesia will be administered followed by TAP block at the end of procedure either Laparoscopy assisted or Ultrasound guided based on the choice of consultant in the theatre.
After Extubation patients will be transferred to the Post-Anaesthetic Care Unit (PACU) for monitoring. Vital signs with pulse oximetry, electrocardiography, and non-invasive blood pressure will be continously monitored. Patients are routinely treated with injection paracetamol 1gm (every 8 hours) intravenously. Injection tramadol 50mg intravenously only if the patient complains of pain.
Patients will be assessed at specified intervals by the postgraduate during the postoperative period: immediately upon arrival at PACU and at 6,12 and 24 hours thereafter for Pain, PONV & any adverse effects of block. Pain intensity will be evaluated using a 10-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain). Time to first rescue analgesic and total tramadol consumption in the first 24hours will be noted. PONV will be evaluated using Impact scale score. |