CTRI Number |
CTRI/2023/05/052421 [Registered on: 09/05/2023] Trial Registered Prospectively |
Last Modified On: |
22/05/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
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Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
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Comparative study between injecting local anesthetic in the chest wall fascial plane and injecting local anesthetic agent at inertion site of key hole procedure instruments for Post-operative Analgesia in patients undergoing key hole cholecystectomy operation
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Scientific Title of Study
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Comparative study between External Oblique Intercostal Fascial Plane block and Port Site Infiltration for Post-operative Analgesia in patients undergoing laparoscopic cholecystectomy
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Trial Acronym |
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Secondary IDs if Any
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Secondary ID |
Identifier |
NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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Name |
DR ARCHITA PATIL |
Designation |
ASSOCIATE PROFFESOR |
Affiliation |
D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Address |
D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE KOLHAPUR
Kolhapur MAHARASHTRA 416003 India |
Phone |
9326853458 |
Fax |
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Email |
drarchita@yahoo.co.uk |
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Details of Contact Person Scientific Query
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Name |
DR ARCHITA PATIL |
Designation |
ASSOCIATE PROFFESOR |
Affiliation |
D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Address |
D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE KOLHAPUR
MAHARASHTRA 416003 India |
Phone |
9326853458 |
Fax |
|
Email |
drarchita@yahoo.co.uk |
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Details of Contact Person Public Query
|
Name |
DR ARCHITA PATIL |
Designation |
ASSOCIATE PROFFESOR |
Affiliation |
D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Address |
D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE KOLHAPUR
MAHARASHTRA 416003 India |
Phone |
9326853458 |
Fax |
|
Email |
drarchita@yahoo.co.uk |
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Source of Monetary or Material Support
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D Y PATIL HOSPITAL, KADAMWADI, KOLHAPUR |
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Primary Sponsor
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Name |
DR ARCHITA PATIL |
Address |
D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUE |
Type of Sponsor |
Other [SELF] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
Sites of Study
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No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DR ARCHITA PATIL |
D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH INSTITUTE |
DEPARTMENT OF ANAESTHESILOGY, FIRST FLOOR, D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH INSTITUTE, KADAMWADI, KOLHAPUR Kolhapur MAHARASHTRA |
9326853458
drarchita@yahoo.co.uk |
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Details of Ethics Committee
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No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE D Y PATIL MEDICAL COLLEGE KOLHAPUR |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
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Type |
Name |
Details |
Intervention |
External Oblique Intercostal Fascial Plane block for laparoscopic cholecystectomy |
To study pain score on Visual Analogue Scale (VAS) post-operatively after laparoscopic cholecystectomy in first 24 hours after administration of external oblique intercostal block.
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Comparator Agent |
Port site infiltration for laparoscopic cholecystectomy. |
To study pain score on Visual Analogue Scale (VAS) post-operatively after laparoscopic cholecystectomy in first 24 hours after administration of port site infiltration.
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Inclusion Criteria
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Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Elective laparoscopic cholecystectomy |
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ExclusionCriteria |
Details |
1 Pregnancy
2 Coagulation disorders
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Method of Generating Random Sequence
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Computer generated randomization |
Method of Concealment
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On-site computer system |
Blinding/Masking
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Participant Blinded |
Primary Outcome
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Outcome |
TimePoints |
1 To know pain score on Visual Analogue Scale (VAS) post-operatively after laparoscopic cholecystectomy in first 24 hours after administration of external oblique intercostal block.
2 To study the total requirement of Inj.Tramadol for post-operative pain in first 24 hours |
Visual Analogue Score (VAS) will be observed at 2 hours, 4 hours, 8 hours and 24 hours interval. |
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Secondary Outcome
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Outcome |
TimePoints |
1 To know pain score on Visual Analogue Scale (VAS) post-operatively after laparoscopic cholecystectomy in first 24 hours after administration of port site infiltration.
2 To study the total requirement of Inj.Tramadol for post-operative pain in first 24 hours |
Visual Analogue Score (VAS) will be observed at 2 hours, 4 hours, 8 hours and 24 hours interval. |
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Target Sample Size
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Total Sample Size="50" Sample Size from India="50"
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
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N/A |
Date of First Enrollment (India)
Modification(s)
|
22/05/2023 |
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
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Baral B, Poudel PR. Comparison of Analgesic Efficacy of Ultrasound Guided Subcostal Transversus Abdominis Plane Block with Port Site Infiltration Following Laparoscopic Cholecystectomy. J Nepal Health Res Counc. 2019 Jan 28;16(41):457-461. PMID: 30739941
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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INTRODUCTION: Laparoscopic cholecystectomy requires multiple port site incisions on anterior abdominal wall in the region of dermatomes T6-T10 leading to somatic pain in the post operative period. Analgesia is provided in the post-operative period by various alternatives like parenteral opioids and NSAIDS along with local anaesthetic infiltration of port sites. To reduce opioid consumption, local anaesthetics can be infiltrated in Fascial planes of abdomen using ultrasound guidance. JUSTIFICATION AND RESEARCH PROBLEM: Anterior and lateral part of upper abdominal wall are not reliably blocked by the Transversus Abdominis Plane (TAP) block [1,2]. A subcostal approach has been shown to block mid abdomen area in T7-12[1] Deeper blocks like Erector spinae and Quadratus lumborum are difficult to perform, require lateral positioning of the patient and cannot be given in patients with coagulopathy. External Oblique fascial plane is superficial in location and well visualised on USG. Cadaveric studies demonstrate its ability to block dermatomes in the supraumbilical region.[3] Hence, we need to study effect of the block in post-operative period.
AIM: To compare the post-operative analgesic effect of ultrasound guided external oblique intercostal fascial plane block with port site infiltration for laparoscopic cholecystectomy. OBJECTIVES: To study pain score on Visual Analogue Scale (VAS) post-operatively after laparoscopic cholecystectomy in first 24 hours after administration of external oblique intercostal block. To study pain score on Visual Analogue Scale (VAS) post-operatively after laparoscopic cholecystectomy in first 24 hours after administration of port site infiltration. To compare pain scores in both the groups. To study the total requirement of Inj.Tramadol for post-operative pain in first 24 hours in both the groups.
STUDY TECHNIQUE: Participants fulfilling inclusion criteria after written informed consent will be enrolled in the study. Pre-operative evaluation and routine investigations of CBC, Blood sugar, S.creatinine and ECG will be carried out to grade the ASA status. By computer generated random sampling, patients will be assigned to either Group A (External Oblique Intercostal Block) or Group B (Port Site Infiltration). Patients will be blinded to the group they are allotted to. Patients will be counselled for VAS score charting. In the operating room, 20 G Intravenous cannula will be secured and monitors attached to record baseline readings of pulse, blood pressure, ECG and SPO2.
Standard anaesthesia protocol will be followed. Patient will be given Inj.Glycopyrollate 0.2 mg and Inj. Fentanyl 100 mcg as pre-medication. Induction agent Inj. Propofol 100 mg and Inj. Succinyl choline 75 mg IV will be given. Intubation with adequate sized cuffed endotracheal tube. Cuff will be inflated and tube secured with tape. Maintenance of anaesthesia will be carried out using O2: Air mixture with FiO2 50%, Sevoflurane 2.5%, and Inj. Vecuronium 4mg and repeated intermittently at 30 min intervals with top up doses of 1mg. At the end of surgery, patients in Group A, will receive unilateral right sided External Oblique Intercostal Fascial Plane Block. Under all aseptic precautions, using ultrasound with linear probe, external oblique muscle will be identified in anterior axillary line on right side at the level of 6th or 7 th rib. A 22G spinal needle will be inserted and fascial plane beneath external oblique targeted. 20 ml of 0.25% inj. Bupivacaine will be injected after negative aspiration for blood and proper plane visualization. Complications during block placement will be noted will be pneumothorax or signs of local anaesthetic toxicity like arrhythmias and cardiac arrest. Patients in Group B will receive 20ml of 0.25% bupivacaine infiltrated at port sites subcutaneously. Patient will be reversed with Inj. Neostigmine 2.5 mg and Inj. Glycopyrollate 0.4mg after stopping all inhalational agents and attempts at spontaneous respiration and extubated. Post-operative monitoring in recovery for next two hours will be done. Postoperative VAS score will be observed in recovery and ward. Staff nurse will be instructed to record pain scores and note first time of analgesic requirement. When patient demands analgesia, Inj. Tramadol 100 mg IV will be given at intervals of 8 hours and not sooner. If pain is not relieved with tramadol after 1 hour, Inj. Diclofenac Sodium will be given 75 mg IM. Total doses of Tramadol in first 24 hours will be noted. Visual Analogue Score (VAS) will be observed at 2 hours, 4 hours, 8 hours and 24 hours interval. Time to demand of first rescue analgesic will be noted.
Total doses of Inj. Tramadol and Diclofenac will be noted. REFERENCES:
Chen Y, Shi K, Xia Y, Zhang X, Papadimos TJ, Xu X, Wang Q. Sensory Assessment and Regression Rate of Bilateral Oblique Subcostal Transversus Abdominis Plane Block in Volunteers. Reg Anesth Pain Med. 2018 Feb;43(2):174-179. doi: 10.1097/AAP.0000000000000715. PMID: 29278604. Arık, E., Akkaya, T., Ozciftci, S. et al. Unilateral transversus abdominis plane block and port-site infiltration. Anaesthesist 69, 270–276 (2020). https://doi.org/10.1007/s00101-020-00746-1 Hensham Elsharkawy, Sree Kolli, Loran Mounir Soliman, John Seif, Richard Drake, The External Oblique Intercostal Block; Anatomic Evaluation and Case series, Pain Medicine, Volume 22, Issue 11, November 2021, Pg2436-2442 Baral B, Poudel PR. Comparison of Analgesic Efficacy of Ultrasound Guided Subcostal Transversus Abdominis Plane Block with Port Site Infiltration Following Laparoscopic Cholecystectomy. J Nepal Health Res Counc. 2019 Jan 28;16(41):457-461. PMID: 30739941
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