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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  
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J42||Unspecified chronic bronchitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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