| CTRI Number |
CTRI/2022/06/043353 [Registered on: 20/06/2022] Trial Registered Prospectively |
| Last Modified On: |
14/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the postoperative pain relief in laparoscopic cholecystectomy by bilateral transverse abdominal plane block and giving the drug intraperitoneal along with skin infiltration. |
|
Scientific Title of Study
|
Comparison of Ultrasound-guided Bilateral Subcostal TAP Block with a combination of Port site Infiltration and Intraperitoneal instillation OF postoperative analgesia in Laparoscopic Cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NIVATHA K |
| Designation |
POST GRADUATE |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology SRM medical college Hospital and
Research Centre, Potheri Kancheepuram-603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7598766699 |
| Fax |
|
| Email |
knivatha3103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NIVATHA K |
| Designation |
POST GRADUATE |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology SRM medical college Hospital and
Research Centre, Potheri Kancheepuram-603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7598766699 |
| Fax |
|
| Email |
knivatha3103@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NIVATHA K |
| Designation |
POST GRADUATE |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology SRM medical college Hospital and
Research Centre, Potheri Kancheepuram-603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7598766699 |
| Fax |
|
| Email |
knivatha3103@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital |
| Address |
Room no:1 ,B Block, Department of Anaesthesiology,
Potheri,Kancheepuram-603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DRRBALAJI |
SRM Hospital |
Room no:1,B BLOCK,
Department of Anaesthesiology,
SRM Medical College Hospital,
Potheri,
Kancheepuram
Kancheepuram
TAMIL NADU |
9677053310
aarbee79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical college hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bilateral Subcostal TAP Block |
bilateral Subcostal TAP block will be performed under ultrasound vision (Logic V2 GE Ultrasound), using a 6 to 15-Hz high-frequency linear probe and a 100-mm needle with the patient lying in supine decubitus position. 20 ml of 0.25% Ropivacaine will be deposited after intubating the patient and before starting the procedure. |
| Comparator Agent |
Intraperitoneal instillation and
port site infiltration |
5 ml of 0.25% Ropivacaine will be infiltrated in each port site before insertion of the trochar. In addition, after creation of pneumoperitoneum, the operating surgeon will be asked to instill 20 ml of 0.25% Ropivacaine proportionately over the gall bladder fossa, liver surface and the parietal peritoneum on the undersurface of the diaphragm before starting the dissection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with ASA Physical Status I and II posted for laparoscopic cholecystectomy
2.Weighing between 50 – 100 kg
|
|
| ExclusionCriteria |
| Details |
1.All patients with ASA Physical Status III and above
2.Patients who refuse to participate in the study
3.Patients who are allergic to amide local anaesthetics
4.Patients who are pregnant
5.Patients with chronic cardiac, renal or hepatic condition
6.Patients with coagulation abnormalities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the duration of postoperative analgesia |
patient is assessed for pain second hourly using Visual Analogue Scale for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To estimate the Consumption of morphine in 24 hour postoperative period
2.Intraoperative consumption of opioids
|
second hourly monitoring is done for 24 hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/06/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
120 patient who meet the inclusion criteria will be allocated into 2 groups by computer generated randomization. GROUP :A Ultrasound guided Subcostal TAP Block GROUP :B Port site infiltration and intraperitoneal instillation. All patients will be premedicated with tab.Alprazolam 0.5 mg preoperatively ,2 hours before shifting to operation theatre. Patients vitals will be monitored with pulse oximetry ,NIBP and ECG. All patients will receive general anesthesia with endotracheal intubation which will be standardized Patients will be induced with Propofol 2 mg /kg and Vecuronium 0.1 mg/kg as the muscle relaxant . Fentanyl 2 mcg/kg will be used as the intraoperative analgesia. Anesthesia will be maintained with Sevoflurane and Vecuronium. After induction of anesthesia , the patient will receive either ultrasound -guided bilateral subcostal TAP Block(GROUP:A) or the combination of port site infiltration and intraperitoneal instillation(GROUP:B) GROUP:A Bilateral Subcostal TAP Block will be performed under ultrasound vision ( Logic V2 GE Ultrasound ), using a 6 to 15- HZ high - frequency linear probe and a 100- mm needle with the patient lying in supine decubitus position. 20 ml of 0,25 % Ropivacaine will be deposited in each side. GROUP:B 5 ml of 0.25% Ropivacaine will be infiltrated in each port site before insertion of the trochar. In addition after creation of pneumoperitoneum , the operating surgeon will be asked to instill 20 ml of 0.25% Ropivacaine propotionately over the gall bladder, liver surface and the patient peritoneum on the undersurface of the diaphragm before starting the dissection. The patient will be extubated at the end of surgery and shifted to recovery. The patient will be shifted to PACU when Aldrete recovery criteria are satisfied .The patient will be continiously monitored in PACU for 24 hours. The pain will be assessed by Visual Analog Scale 0 : NO PAIN 1-2 : MILD PAIN INTENSITY 3-5 : MODERATE PAIN INTENSITY 6-8 : SEVERE PAIN INTENSITY 9-10 : WORST PAIN The duration of postoperative analgesia is defined as the time taken from the completion of block or infiltration to the first request for the postoperative analgesia (VAS >3) The patient will be started on the patient control analgesia using morphine with a bolus dose of 1mg and lockout interval of 10 minutes. The total consumption of morphine will be noted . The occurance of any adverse effects like nausea , Vomiting , itching and respiratory depression will be noted and treated accordingly
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