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
|
|
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
|
|
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 perÂformed 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 surÂgery, 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 imaginableâ€. The NRS scores at rest and in motion will recorded by an anaesthetist who did not know the group distribuÂtions 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 preopÂerative period. The primary aim is to compare the total opioid (tramadol) consumption in 24 hours in the groups. Also time of first resÂcue analgesic administration will also be recorded. |