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.
- Conditions
- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,
- Registration Number
- CTRI/2020/01/023039
- Lead Sponsor
- Pallavi nair
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 86
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method To evaluate requirement of post operative analgesia in patients recieving TAP block under laparoscopic vision during laparoscopic cholecystectomy
Trial Locations
- Locations (1)
KALINGA INSTITUTE OF MEDICAL SCIENCES,BBSR
🇮🇳Khordha, ORISSA, India
KALINGA INSTITUTE OF MEDICAL SCIENCES,BBSR🇮🇳Khordha, ORISSA, IndiaPALLAVI NAIRPrincipal investigator9556882980pallavinair321@gmail.com