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CTRI Number  CTRI/2024/06/069162 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 17/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Trial to determine the better timing of administration of Transversus Abdominis Plane (TAP) Block in patients of Transabdominal preperitoneal (TAPP) Inguinal hernia repair in management of postoperative pain. 
Scientific Title of Study   Randomised Control trial (RCT) for Comparing Postoperative pain in patients undergoing Transabdominal preperitoneal (TAPP) Inguinal hernia repair: Transversus Abdominis Plane (TAP) Block before peritoneal incision vs. Transversus Abdominis Plane (TAP) Block after peritoneal incision closure 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shyam J Patel 
Designation  Resident of General Surgery 
Affiliation   
Address  AlIMS Jodhpur General Surgery department - Room 525, 5th floor OPD, AllMS Jodhpur OPD, Basni, Phase-2, Jodhpur, Rajasthan- 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9426212359  
Fax    
Email  shyamjpatel008@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naveen Sharma  
Designation  HOD of General Surgery, AIIMS Jodhpur 
Affiliation  AIIMS Jodhpur (General Surgery department) 
Address  AlIMS Jodhpur General Surgery department - Room 525, 5th floor OPD, AllMS Jodhpur OPD, Basni, Phase-2, Jodhpur, Rajasthan- 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9953771090  
Fax    
Email  drnsemail@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Naveen Sharma  
Designation  HOD of General Surgery, AIIMS Jodhpur 
Affiliation  AIIMS Jodhpur (General Surgery department) 
Address  AlIMS Jodhpur General Surgery department - Room 525, 5th floor OPD, AllMS Jodhpur OPD, Basni, Phase-2, Jodhpur, Rajasthan- 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9953771090  
Fax    
Email  drnsemail@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur 
 
Primary Sponsor  
Name  Dr. Naveen Sharma 
Address  AlIMS Jodhpur General Surgery department - Room 525, 5th floor OPD, AllMS Jodhpur OPD, Basni, Phase-2, Jodhpur, Rajasthan- 342005 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Shyam Patel  AIIMS Jodhpur   AlIMS Jodhpur General Surgery department - Room 525, 5th floor OPD, AlIMS Jodhpur OPD, Basni, Phase-2, Jodhpur, Rajasthan- 342005
Jodhpur
RAJASTHAN 
9426212359

shyamjpatel008@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Jodhpur Institutional Ethics Committee (Clinical Trial)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Transversus Abdominis Plane (TAP) Block  Patients recruited in the study will be randomized into two groups: Group A - Patients undergoing Elective Laparoscopic TAPP inguinal hernia repair with TAP block done before peritoneal incision. Group B - Patients undergoing Elective Laparoscopic TAPP inguinal hernia repair with TAP block done after peritoneal incision closure. All patients will receive I.V. anaesthetic (Propofol) induction with fentanyl 2mcg/kg and maintenance with inhalation agents (Isoflurane). I.V. Paracetamol in all patients before extubating.( ( dose: 1 gm in 50 kgs or 15 mg/kg in 50 kgs) All patients will receive subcutaneous bupivacaine (0.25%) at port sites at least 2 minutes before incision of skin. Timing of TAP block will be different in two groups but steps of giving TAP block will be same.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
1. Patients who give informed consent
2. Patients scheduled for elective TAPP inguinal hernia repair.
3. Patients between 18 and 75 years.
4. Patient with ASA (American Society of Anaesthesiologists) physical status I or II.
 
 
ExclusionCriteria 
Details  Exclusion criteria:
1. Patients who underwent a conversion to open surgery.
2. Patients who are allergic to local anaesthetics.
3. Patient with known history of chronic opioid use.
4. Patient with known history of coagulopathy or bleeding disorders.
5. Local skin conditions excluding block administration
6. Irreducible and strangulated hernia.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Postoperative pain scores using a numerical rating scale (NRS)  at 1 hour, 6 hours, 24 hours and 7 days after extubating 
 
Secondary Outcome  
Outcome  TimePoints 
1 Duration of analgesia by Transverse abdominis block.
2 The time of first rescue analgesic dose after block.
3 Post operative analgesic requirement after surgery.
4 Time to ambulation after surgery.
5 Time to return to work after surgery.
 
1 hour, 6 hours, 24 hours and 7 days after extubating using a numerical rating  
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/07/2024 
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="6"
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  

Introduction: 

Surgery is the main method for the treatment of inguinal hernia. With the development of laparoscopic technology, laparoscopic inguinal hernia repair (LIHR) has gradually been adopted in clinical practice. The preferred LIHR operations for adult inguinal hernia management are transabdominal preperitoneal (TAPP) inguinal hernia repair and totally extraperitoneal (TEP) inguinal hernia repair. TAPP is more commonly performed surgery than TEP. Compared with traditional open surgery, minimally invasive surgery can relieve patients’ surgical trauma, reduce the risk of postoperative complications, and limit patients’ postoperative pain, making it the preferred surgical method for the clinical treatment of inguinal hernia at present .

In a qualitative systematic review, pain after both TAPP and TEP repair was found to be of a similar character, that is, lower abdominal groin pain of moderate to severe intensity, more on the first day that increased on coughing and mobilization. Shoulder tip pain due to pneumoperitoneum or somatic pain was not prominent after either type of repair. This has led to the use of techniques such as preperitoneal instillation of local anaesthetic at port site, epidural analgesia, and transversus abdominis plane block for postoperative pain control.

Transverse Abdominis Plane (TAP) block has been used to provide effective analgesia for a number of lower abdominal procedures such as lower segment caesarean section, total abdominal hysterectomy, open appendicectomy, open hernia surgery, and in renal transplant recipients. However, there is inconclusive literature regarding the timing of TAP block for providing better postoperative analgesia for laparoscopic hernia repair.

This study will be designed to compare  effect of TAP block before peritoneal incision  with TAP block after peritoneal incision closure on pain score at multiple times postoperatively at rest and on movement and postoperative analgesic requirement in the first 6 hours, 24 hours and after 7 days of laparoscopic hernia TAPP repair.

 Rationale of the study supported by cited literature:

Inguinal Hernia is one of the most common surgical condition with preferred surgical management being transabdominal preperitoneal (TAPP) inguinal hernia repair. According to previous studies, mild/moderate pain (VAS= 0-6) is present after this surgery. TAP block, an already established method of postoperative pain control can be used for management of this postoperative pain. Determining the time of TAP block administration for better postoperative pain control will help reduce patient morbidity, reduce postoperative analgesic requirement, reduce hospital stay and will ensure early return to work.

 

Hypothesis:

Administration of TAP block before peritoneal incision will cause less postoperative pain in TAPP inguinal hernia repair patients as compared to administration of TAP block after peritoneal incision closure.

 

Research questions: 

Does the timing of Tranversus abdominis plane (TAP) block - before peritoneal incision vs after closure of peritoneal incision affect the post operative pain in laparoscopic and robotic TAPP inguinal hernia repair patients?

 

Aim

To evaluate the role of timing of Tranversus abdominis plane (TAP) block in decreasing postoperative pain in laparoscopic TAPP hernia repair.

Objectives: 

Primary Objective:

            1.Compare postoperative pain scores between patients receiving TAP block before peritoneal incision and those receiving it after peritoneal incision closure.

Secondary Objective:

1. To compare postoperative analgesic requirement after 1 hour, 6hrs, 24hr and 7 days of inguinal hernia repair in each group.

2. Assess the duration and quality of postoperative analgesia in both groups.

                      3. Evaluate the overall patient satisfaction with pain management in each group.

 

Detailed methodology:

Study Design:

This will be a randomized controlled trial

 

Study setting:

This comparative study will be conducted in the Department of General Surgery, AIIMS, Jodhpur after obtaining due clearance from the Institutional Review board and Ethics Committee. The ICMR/ GCP guidelines for randomized trials will be followed and the study will be registered in the Clinical Trial Registry- India (CTRI).

 

Study Duration:

18 months after obtaining due clearance from the Institutional Review board and Ethics Committee

 

Method:

Patients recruited in the study will be randomized into two groups:

Group A - Patients undergoing Elective Laparoscopic TAPP inguinal hernia repair with TAP block done before peritoneal incision.

Group B - Patients undergoing Elective Laparoscopic TAPP inguinal hernia repair with TAP block done after peritoneal incision closure.

 

All patients will receive I.V. anaesthetic (Propofol) induction with fentanyl 2mcg/kg and maintenance with inhalation agents (Isoflurane). I.V. Paracetamol  in all patients before finishing surgery ( dose: 1 gm in > 50 kgs or 15 mg/kg in <50 kgs)

 

All patients will receive subcutaneous bupivacaine (0.25%) at port sites at least 2 minutes 

before incision of skin.

 

Timing of TAP block will be different in two groups but stepsof giving TAP block will be same.

 

Steps for TAP Block:

1.Set-up a sterile field

2.Mark the following external landmarks :costal margin and iliac crest

 and make a line where these intersect laterally.                 

3.Insert  needle at this point of intersection under direct vision. 

4.Identify the correct plane between Internal Oblique muscle and Transversus Abdominis Muscle before administering anaesthetic agent using following sign: 

"Double pop sign"- 2 pops are felt while the  needle passes through the External Oblique and Internal Oblique muscles respectively.

5. Aspirate to ensure no blood return

6. Inject required amount of  anaesthetic agent

7. Gently remove the needle

 

Postoperative pain management protocol:

All patients to receive Paracetamol 1 gm 8 hourly for pain management

For rescue analgesia, Tramadol 100 mg as needed and requirement to be recorded in data collection 

 

Patients not giving consent will not be included in the study. Details of patients who refuse consent and the reason for refusal of consent will be noted. Refusal of consent for the participation in the study will not affect the treatment of the patients in any way.

 

Data Collection:

a. Demographic data, intraoperative variables, and postoperative pain scores will be recorded.

b. Patient-reported outcomes will be collected using standardized questionnaires

 

Inclusion criteria:

1.    Patients who give informed consent

2.    Patients scheduled for elective TAPP inguinal hernia repair.

3.    Patients between 18 and 75 years.

4.    Patient with ASA (American Society of Anaesthesiologists) physical status I or II.

 

Exclusion criteria:

    1. Patients who underwent a conversion to open surgery.
    2. Patients who are allergic to local anaesthetics.
    3. Patient with known history of chronic opioid use.
    4. Patient with known history of coagulopathy or bleeding disorders.
    5. Local skin conditions excluding block administration
    6. Irreducible and strangulated hernia.

Data analysis plan:

a. Descriptive statistics will be used for demographic data.
b. Inferential statistics will be employed to compare outcomes between groups. 

c. A p-value < 0.05 will be considered statistically significant. 
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