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CTRI Number  CTRI/2020/01/023039 [Registered on: 30/01/2020] Trial Registered Prospectively
Last Modified On: 28/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The study is to asses pain relief by laparoscopic injection given on both sides of upper abdomen in patients undergoing laparoscopic cholecystectomy,recieving pain killers only when asked for. 
Scientific Title of Study   A Randomized trial on efficacy of Laparoscopic Transversus Abdominis Plane Block in patients undergoing Laparoscopic Cholecystectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PALLAVI NAIR 
Designation  1 YEAR PGT 
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES 
Address  DEPT OF GENERAL SURGERY KIMS BHUBANESWAR ORISSA
DEPT OF GENERAL SURGERY GIRLS HOSTEL BLOCK D ROOM-2D 60 KIMS BHUBANESWAR ORISSA
Khordha
ORISSA
751024
India 
Phone  9556882980  
Fax    
Email  pallavinair321@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PROFDR AMARESH MISHRA 
Designation  PROFESSOR GENERAL SURGERY 
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES 
Address  DEPT OF GENERAL SURGERY KIMS BHUBANESWAR ORISSA
DEPT OF GENERAL SURGERY KIMS BHUBANESWAR ORISSA
Khordha
ORISSA
751024
India 
Phone  9437554488  
Fax    
Email  amareshm26@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PALLAVI NAIR 
Designation  1 YEAR PGT 
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES 
Address  DEPT OF GENERAL SURGERY KIMS BHUBANESWAR ORISSA
DEPT OF GENERAL SURGERY KIMS BHUBANESWAR ORISSA
Khordha
ORISSA
751024
India 
Phone  9556882980  
Fax    
Email  pallavinair321@gmail.com  
 
Source of Monetary or Material Support  
SELF 
 
Primary Sponsor  
Name  Pallavi nair 
Address  Dept of general surgery kims hospital odisa  
Type of Sponsor  Other [SELF] 
 
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 
PALLAVI NAIR  KALINGA INSTITUTE OF MEDICAL SCIENCES,BBSR  DEPT OF GENERAL SURGERY KIMS BHUBANESWAR ORISSA
Khordha
ORISSA 
9556882980

pallavinair321@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KALINGA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  analgesics 8 hourly- inj tramadol 100 mg in 100ml ns/ inj paracetamol 1gm iv/inj diclogesic  pain will be assessed 8 hourly and anlgesics will be administered. 
Intervention  LAPAROSCOPIC TRANSVERSUS ABDOMINIS BLOCK IN ONE GROUP ONLY  LAPAROSCOPIC TRANSVERSUS ABDOMINIS(TAP BLOCK) BLOCK WITH 0.25 % 20 ML BUPIVACAINE (LOCAL ANESTHETIC) ON BOTH SIDES SUBCOSTALLY IN ONE GROUP ALONG WITH OTHER ANALGESISCS AS AND WHEN REQUIRED AND SECOND GROUP WITH NO TAP BLOCK AND REGULAR ANALGESICS 6TH HOURLY AND AS AND WHEN REQUIRED. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)The patients aged between 20- 80years who are undergoing laparoscopic cholecystectomy at our hospital.(ASA I and II)

2)The patients who will be willing to comply with the study group.
 
 
ExclusionCriteria 
Details  1) Patients with gallbladder empyema
2) Intra-abdominal adhesions due to previous upper abdominal surgery
3)Additional disease that may effect the biliary tract surgery
4)Bleeding disorder
5)Provisional diagnosis of gallbladder cancer
6)Incomplete data
7)ASA grade more than II 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness and safety of Transversus abdominis plane (TAP) block for post- operative pain control under laparoscopic vision during laparoscopic cholecystectomy
 
The patients will be assessed immediately after surgery in post op ,at end of 1 hour and then every 4 th hourly . 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate requirement of post operative analgesia in patients recieving TAP block under laparoscopic vision during laparoscopic cholecystectomy
 
0 hour, 4 hour ,8 hour ,12 hour , 24 hour 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   01/02/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

INTRODUCTION:

Laparoscopic Cholecystectomy is a minimally invasive  procedure ,still it is associated with significant incidence of post-operative pain especially in the first 24 hr following surgery.

Transversus Abdominis Plane (TAP) block was first described by Kuppuvelumani et al.

TAP block technique = first reported by Rafi= in 2001.

Owel et al =first described the open surgical approach for TAP block.

In 2011=pure laparoscopic TAP block = reported as a new technique.

Magee et al= performed TAP block under direct laparoscopic vision prior to laparoscopic surgical intervention The anatomical compartment between the transversus abdominis muscle and abdominal oblique internus muscle is described as TAP.

The bolus anesthetic injection into this neurovascular fascial plane provides blockage of dermatomal afferents of T7-11 intercostal nerves,T12 subcostal nerve,ilioinguinal and iliohypogastric nerves and cutaneous branches of L1-3 nerves

 Laparoscopic assisted TAP block is suggested as an alternative to USG guided block as it is :

  1) Less time consuming

  2) Does not need extra equipments (USG machine)

Laparoscopic assisted TAP block is faster and equally efficacious when compared with usg-guided block and has a definite role in centers where usg is not available in operating rooms.

 Its a new promising technique which will help surgeons  to manage post operative pain of laparoscopic cholecystectomy patients and hence improve patient and surgical outcomes.

 TAP block is cost effective,one of the safest,easiest and one of the most effective pain control technique .


AIM AND OBJECTIVES:

To evaluate the effectiveness and safety of Transversus abdominis plane (TAP) block for post- operative pain control under laparoscopic vision during laparoscopic cholecystectomy.

To compare requirement of additional analgesics in patients undergoing laparoscopic cholecystectomy with and without TAP block.

MATERIALS AND METHODOLOGY:

Study Design-

Place of study : Department Of General Surgery,KIMS,Bhubaneswar

Prospective study design from September 2019 to September 2021(2 years) .

Participants will be divided into 2 groups.Randomization with be done according to a computerized method. One group will recieve laparoscopy guided subcostal TAP block bilaterally along with parentral analgesics (parentral tramadol/paracetamol/diclofenac) and Second group will recieve parentral analgesics 6th hourly and also sos.

After end of lap. cholecystectomy ,TAP block will be applied  to one group.

Punture with an 22 G needle will be performed in right and left subcostal region, lateral to rectus .Localization of the needle will be detected under laparoscopic vision

and when the needle tip is positioned at the fascial space between the internal oblique and the transversus abdominis muscle ,after a preventive aspiration,20 ml of 0.25 % bupivacaine will be injected bilaterally. Bulging inferiorly of the transversus abdominis muscle away from the internal oblique will be observed using laparoscope thus Confirming exact placement of local anesthetic in TAP  

Groups will be evaluated according to the

- Patient’s age

-Gender

-Requirement of analgesia post surgery in both groups.

-Numeric rating score(NRS) for assessment of  post-operative pain at 0, 4 hr, 8 hr,12 hr and 24 hr.

-for length of stay in hospital.

 
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