CTRI Number |
CTRI/2025/03/082278 [Registered on: 13/03/2025] Trial Registered Prospectively |
Last Modified On: |
12/03/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
evaluation of usg guided bilateral tap block versus intraperitoneal instillation of levobupivacaine for post operative analgesia in laparoscopic abdominal surgeries |
Scientific Title of Study
|
Clinical evaluation of ultrasound guided bilateral tap block versus intraperitoneal instillation of levobupivacaine for post operative analgesia in laparoscopic abdominal surgeries. |
Trial Acronym |
nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
AISHWARYA SHRIVASTAVA |
Designation |
JUNIOR RESIDENT |
Affiliation |
GANDHI MEDICAL COLLEGE |
Address |
2nd floor anaesthesiology department Gandhi medical college and hospital anaesthesiology department 2nd floor gandhi medical college Bhopal MADHYA PRADESH 462039 India |
Phone |
8319657804 |
Fax |
|
Email |
waryaish26@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
SURENDRA RAIKWAR |
Designation |
PROFESSOR |
Affiliation |
GANDHI MEDICAL COLLEGE |
Address |
2nd floor anaesthesiolohgy department Gandhi medical college and hospital anaesthesiology department gandhi medical college Bhopal MADHYA PRADESH 462001 India |
Phone |
08319657804 |
Fax |
|
Email |
drskraikwar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
AISHWARYA SHRIVASTAVA |
Designation |
JUNIOR RESIDENT |
Affiliation |
GANDHI MEDICAL COLLEGE |
Address |
2nd floor anaesthesiology department Gandhi medical college and hospital Gandhi medical college 2nd floor anaesthesia department
MADHYA PRADESH 462039 India |
Phone |
8319657804 |
Fax |
|
Email |
waryaish26@gmail.com |
|
Source of Monetary or Material Support
|
DEPARTMENT OF ANAESTHESIOLOGY ,GANDHI MEDICAL COLLEGE,BHOPAL 462001 india |
|
Primary Sponsor
|
Name |
GANDHI MEDICAL COLLEGE |
Address |
GANDHI MEDICAL COLLEGE, BHOPAL(M.P) 462001 India |
Type of Sponsor |
Government medical college |
|
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 AISHWARYA SHRIVASTAVA |
GANDHI MEDICAL COLLEGE |
department of anaesthesiology 2nd floor Gandhi medical college Bhopal MADHYA PRADESH |
08319657804
waryaish26@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUNAL ETHICS COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J42||Unspecified chronic bronchitis, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patients of ASA grade - I ,II
2. Age group 18-60 years of either sex.
3. All patients scheduled for elective laparoscopic abdominal surgery
|
|
ExclusionCriteria |
Details |
1 Patient refusal or not giving consent.
2 Pregnancy
3 Patient with coagulopathies
4 Seizure disorder
5 ASA grade III and above
6 Patient on anticoagulants
• Patient consuming adrenoreceptors agonist or antagonist
• History of drug allergy levobupivacaine
• Patients with history of cardiac, respiratory, renal or hepatic failure.
• Difficult Airway.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
TAP block is better that usg guided intraperitoneal instillation of levobupivacaine for post op analgesia |
10 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
to assess the total resue analgesia consumptiion in 24hrs. to estimate the duration of analgesia after tap block |
8 weeks |
|
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)
|
23/03/2025 |
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
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
· Abdominal laproscopic surgeries are most commonly associated with moderate to severe post operative pain .Pain is because of incisional site pain (somatic) and visecral (deep intrabdominal) . Visceral pain after laparoscopic surgery can be triggered by traction of peritoneum or by irritation of the diaphragm following surgical manipulation, intraoperative gas insufflation and post operative gas retention. · Acute postoperative pain is a complex physiological reaction, and it is detrimental because it increases the patient’s discomfort and may transform into chronic pain. Optimal postoperative analgesia is important to prevent negative outcomes. · In addition to the parental opioids and NSAIDS, various other method use for post operative analgesia are infilteration of local anaesthetic agent, dermal patch, patient controlled analgesia and epidural catheter etc. · Instillation of local anaesthesia intraperitoneally around the operative site is used as an analgesic technique on the assumption that conduction from visceral sites is obstructed and may lessen the intensity of referred pain to the shoulder (C3 and C4) which results from irritation of diaphragmatic innervation. i.e. phrenic nerve (C3, C4, C5) and diaphragmatic stretching due to gaseous retention in the postoperative period. · Intraperitoneal instillation of non steroidal anti inflammatory drug (NSAIDS) and narcotics, gas drainage, intraperitoneal local anesthetic drug alone or with opioids and alpha 2 agonist drugs such as clonidine and dexmedetomidine before the end of the surgery by the surgeon is routinely performed before trocar removal at the surgical site can decrease the postoperative pain after laparoscopic surgery. · The Transverse abdominal plane block is relatively newer and a novel approach of injecting local anaesthetic agent the plane between the internal oblique and transversus abdominis muscle and thus giving pain relief. · The TAP block can provide excellent analgesia to the skin and muscles of the anterior abdominal wall following the inguinal hernia repair, appendectomy, radical prostatectomy, abdominoplasty, renal transplantation, large bowel resection, cesarean section, laproscopic cholecystectomy and Iliac crest bone grafting. · We intend to assess the analgesic efficacy of ultrasound guided bilateral TAP block versus intraperitoneal instillation of levobupivacaine in patients undergoing laparoscopic abdominal surgeries. | |