Comparison of postoperative analgesic effect between ultrasound guided transverse abdominis plane block and local infiltration of local anaesthesia-bupivacaine 0.5% at port site in patients undergoing laparoscopic cholecystectomy.

Completed

Conditions: Calculus of gallbladder without cholecystitis,

Registration Number: CTRI/2019/11/022006

Lead Sponsor: Sri Ramachandra Institute of Higher Education and Research Deemed to be University

Brief Summary: Patients coming for laparoscopic cholecystectomy who fit into the inclusion criteria will be included in the study. Patients enrolled in the study will be explained about the study drugs and the possible advantages and disadvantages and their consent will be obtained. Patients will be assessed on the previous day and nil per oral orders for atleast 8 hours will be maintained.

On day of surgery, patient will be brought to the or , baseline monitors will be connected and baseline vitals will be recorded.

The study drugs will be prepared by an anaesthesiologist who is not involved in the study.

Group-A:- allotted drug for this group will be delivered in the transverse abdominis plane by another anaesthesiologist who is well versed in giving blocks with the aid of an ultrasound. Ultrasoundguided subcostal transverse abdominis plane block will be performed bilaterally before surgical incision. Ultrasound probe will be placed transversely in the midaxillary line below the costal margin. The external oblique , internal oblique and transverse abdominis muscle and their fascia will be visualised. A 100 mm needle will be introduced anteriorly and in the plane of the probe and on entering the transverse abdominis plane , 2 ml of saline will be injected to verify the correct position of the needle. After negative aspiration , 15 ml of study solution will be injected and the separation of fascial layer between transverse abdominis and internal oblique is considered as proper placement of the drug. Similarly subcostal transverse abdominis plane block will be done on the contralateral side.

Group-B:- allotted drug for this group will be delivered

Subcutaneously 5ml at each of the four port sites.

Intraoperative haemodynamics will be monitored and recorded . We will assess the post operative pain and the need for rescue analgesics in the immediate post operative period. If vas score >4 in the post anaesthesia care unit(1hr post operatively) in patients who received tap block will be considered to have block failure and such patients will be excluded from the study.

**Analysis**

Pain to be assessed using visual analogue scale(vas).

Pain scores to be assessed at 30mins, 1hr,2hrs, 4 hrs, 8 hrs.

If pain score more than 4, rescue analgesia will be given.

Post operative spo2 monitoring every 30mins, for 24hrs.

rescue analgesia

Inj paracetamol 1 gm iv, if no relief with inj paracetamol in 30 min

Inj diclofenac 75mg im will be given .

primary outcome

Vas score post operatively

Duration of post operative analgesia

(duration is the time from performance of block/local infiltration to the first pain score =>4 . )

secondary outcome

Time for first rescue analgesia

Number of doses of rescue analgesia given

Postoperative oxygen saturation monitoring.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 64

Inclusion Criteria

Patients with calculus cholelithiasis.
ASA I, II, III.

Exclusion Criteria

Patient non compliance Heart rate<60 bpm Baseline systolic bp <100mmhg BMI<18 or >35 kg/m2 Allergic to study drugs Infection at injection site Coagulopathy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain will be assessed using visual analogue scale(VAS) at postoperative 30mins, 1hr, 2hrs, 4hrs, 8 hr.	Pain will be assessed using visual analogue scale(VAS) at postoperative 30mins, 1hr, 2hrs, 4hrs, 8 hr. \| If pain score more than 4, rescue analgesia will be given. \| Inj Paracetamol 1 gm IV will be first line analgesic. \| If no relief with Inj Paracetamol 1 gm in 30 min, Inj. Diclofenac 75mg IM is given as second line analgesic.
If pain score more than 4, rescue analgesia will be given.	Pain will be assessed using visual analogue scale(VAS) at postoperative 30mins, 1hr, 2hrs, 4hrs, 8 hr. \| If pain score more than 4, rescue analgesia will be given. \| Inj Paracetamol 1 gm IV will be first line analgesic. \| If no relief with Inj Paracetamol 1 gm in 30 min, Inj. Diclofenac 75mg IM is given as second line analgesic.
Inj Paracetamol 1 gm IV will be first line analgesic.	Pain will be assessed using visual analogue scale(VAS) at postoperative 30mins, 1hr, 2hrs, 4hrs, 8 hr. \| If pain score more than 4, rescue analgesia will be given. \| Inj Paracetamol 1 gm IV will be first line analgesic. \| If no relief with Inj Paracetamol 1 gm in 30 min, Inj. Diclofenac 75mg IM is given as second line analgesic.
If no relief with Inj Paracetamol 1 gm in 30 min, Inj. Diclofenac 75mg IM is given as second line analgesic.	Pain will be assessed using visual analogue scale(VAS) at postoperative 30mins, 1hr, 2hrs, 4hrs, 8 hr. \| If pain score more than 4, rescue analgesia will be given. \| Inj Paracetamol 1 gm IV will be first line analgesic. \| If no relief with Inj Paracetamol 1 gm in 30 min, Inj. Diclofenac 75mg IM is given as second line analgesic.

Secondary Outcome Measures

Name	Time	Method
Postoperative Spo2 monitoring will be done for every 30mins for first 24hrs.	Postoperative 30mins, 1hr, 2hrs, 4hrs, 8 hr.

Trial Locations

Locations (1): Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)
🇮🇳
Chennai, TAMIL NADU, India
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)
🇮🇳Chennai, TAMIL NADU, India
Mathi Sri Akshay
Principal investigator
9640737722
sriakshaymathi@gmail.com