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CTRI Number  CTRI/2023/10/058886 [Registered on: 19/10/2023] Trial Registered Prospectively
Last Modified On: 13/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two pain relief injection techniques, one at the muscle level near 7th rib and the other near 10th rib in patients undergoing gall bladder surgeries 
Scientific Title of Study   Post Operative Analgesic Efficacy Of Ultrasound Guided External Oblique Intercostal (EOI) Block Vs Modified Thoraco-Abdominal Nerves Block Through Perichondrial Approach (M-TAPA) After Laparoscopic Cholecystectomy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Praveen R 
Designation  Assistant Professor 
Affiliation  ESIC Medical College and Hospital 
Address  Dept. of Anaesthesiology, ESIC Medical College and Hospital, Ashok Pillar Main Rd, K. K. Nagar

Chennai
TAMIL NADU
600094
India 
Phone  8015167455  
Fax    
Email  drpraveenramasamy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Praveen R 
Designation  Assistant Professor 
Affiliation  ESIC Medical College and Hospital 
Address  Dept. of Anaesthesiology, ESIC Medical College and Hospital, Ashok Pillar Main Rd, K. K. Nagar

Chennai
TAMIL NADU
600094
India 
Phone  8015167455  
Fax    
Email  drpraveenramasamy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Praveen R 
Designation  Assistant Professor 
Affiliation  ESIC Medical College and Hospital 
Address  Dept. of Anaesthesiology, ESIC Medical College and Hospital, Ashok Pillar Main Rd, K. K. Nagar

Chennai
TAMIL NADU
600094
India 
Phone  8015167455  
Fax    
Email  drpraveenramasamy@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical College and Hospital 
 
Primary Sponsor  
Name  Praveen R 
Address  Dept. of Anaesthesiology, ESIC Medical College and PGIMSR, Ashok Pillar Main Rd, K. K. Nagar, Chennai, Tamil Nadu - 600078  
Type of Sponsor  Other [Individual] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praveen R  ESIC Medical College and Hospital  Dept. of Anaesthesiology, ESIC Medical College and Hospital, Ashok Pillar Main Rd, K. K. Nagar
Chennai
TAMIL NADU 
8015167455

drpraveenramasamy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ESIC Medical College and Hospital, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  External Oblique Intercostal (EOI) Block  For Group EOIB, a high-frequency linear probe (6–13 MHz) is placed at the anterior axillary line, and the external oblique muscle identified at the level of ribs 6 and 7 in line with the xiphoid process. The EOI plane is identified deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles. By using the in-plane technique, a 22G, 80 mm block needle is placed in the plane and 20 ml of 0.25% Ropivacaine will be administered. The same procedure will be applied to the other side (40 ml of 0.25% bupivacaine in total). The approximate duration for the technique is around 10 minutes 
Comparator Agent  Modified Thoraco-Abdominal Nerves Block Through Perichondrial Approach (M-TAPA)  For M-TAPA group, a high-frequency linear probe (6–13 MHz) will placed in the para sagittal direction on the 10th costal margin. The probe is angled deeply to view the lower aspect of the chondrium. By using the in-plane technique, a 22G, 80 mm block needle is placed between the transversus abdominis muscle and the lower surface of the costal cartilage and 20 ml of 0.25% Ropivacaine is injected into the lower surface of the chondrium. The same process is then repeated for the other side. The total duration of the intervention is around 10 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Patient with written informed consent
2. ASA physical status I and II
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Known allergy to any one of the drugs used
3. Patients with Infection at the site of block
4. Patients with bleeding diathesis
5. Patients on anticoagulant treatment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the total opioid (tramadol) consumption between the two groups at the postoperative 24th hour  0, 2nd hour, 4th hour, 8th hour, 16th hour and 24th hour 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the postoperative pain scores
2. To compare the time of first rescue analgesic administration.
 
0, 2nd hour, 4th hour, 8th hour, 16th hour and 24th hour 
 
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   Phase 2 
Date of First Enrollment (India)   10/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/11/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Laparoscopic Cholecystectomy is a commonly per­formed surgery in the treatment of symptomatic gallstone disease all over the world. Though minimally invasive, it can cause moderate-severe pain. Post-operative pain is a serious problem that impairs the quality of recovery and increases the risk of other postoperative complications. Many methods to treat postoperative pain such as patient controlled analgesia, epidural analgesia, intravenous analgesia, intraperitoneal local anaesthetic injection, oral and intravenous drugs including opioids are widely used. Certain  nerve blocks are also given but they provide effective analgesia  either in the midabdominal region or in the lateral abdominal region but not in both regions. Novel techniques like USG guided External Oblique Intercostal (EOI) block, Thoracoabdominal nerves block through perichondrial approach (TAPA) and then modified-TAPA (m-TAPA) block, a modification of this block are recently being used for effective analgesia in  both the anterior and lateral abdominal walls after laparoscopic surgeries. However, there is limited literature comparing EOI and M-TAPA. The primary purpose of this study is to compare the analgesic efficacy among EOI and M-TAPA  and to include as part of multimodal analgesia to reduce postoperative opioid consumption in patients undergoing Laparoscopic Cholecystectomy.


CONDUCT OF ANAESTHESIA :

 

After arrival in the operating room, standard monitoring including electrocardiogram (ECG), pulse oxygen saturation (SPO2), non-invasive blood pressure (NIBP) and heart rate (HR) will be monitored. An 18-gauge cannula will be secured on non-dominant hand. All patients will receive i/v fentanyl 2mcg/kg, 5 minutes before induction followed by, inj. propofol 2mg/ kg till loss of verbal command. Tracheal intubation will be facilitated by vecuronium 0.1mg/kg and mechanical ventilation will be provided using oxygen and air in ratio of 50:50 with total flow of 3L/ min along with inhalational agents (desflurane /sevoflurane) to achieve 1 MAC. Inj. Fentanyl 20mcg hourly bolus will be given to keep the mean arterial blood pressure of the patients within 20% of the baseline. IV Tramadol 1 mg/kg was given at the end of surgery. Following the completion of the sur­gery, the patients will be extubated and transferred to the post-anaesthesia care unit (PACU). The patients will be shifted to the ward when the Modified Aldreth Score ≥ 8.


Nerve Block intervention:

Following surgery, for Group EOIB, a high-frequency linear probe (6–13 MHz) is  placed at the anterior axillary line, and the external oblique muscle identified at the level of ribs 6 and 7 in line with the xiphoid process. The EOI plane is identified deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles. By using the in-plane technique, a 22G, 80 mm block needle is placed in the plane and 20 ml of 0.25% Ropivacaine will be administered. The same procedure will be applied to the other side (40 ml of 0.25% bupivacaine in total).For M-TAPA group, a high-frequency linear probe (6–13 MHz) will placed in the  para sagittal direction on the 10th costal margin. The probe is angled deeply to view the lower aspect of the chondrium. By using the in-plane technique, a 22G, 80 mm block needle is placed between the transversus abdominis muscle and the lower surface of the costal cartilage and 20 ml of 0.25% Ropivacaine is injected into the lower surface of the chondrium. The same process is then repeated for the other side.

Evaluation of pain will be done using Numeric Rating Scale (NRS). It is a numerical scale in which the respondent selects an number between 0 to 10 that best reflects the intensity of the pain. In this regard, “0” meant “no pain” and “10” meant “worst pain imaginable”. The NRS scores at rest and in motion will recorded by an anaesthetist who did not know the group distribu­tions at postoperative hour 0, 2nd hour, 4th hour, 8th hour, 16th hour and 24th hour. Patients will be educated and familiarized with NRS scores at the preop­erative period. The primary aim is to compare the total opioid (tramadol) consumption in 24 hours in the groups. Also time of first res­cue analgesic administration will also be recorded.

 
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