Comparison of sonography guided abdominal nerves block versus local injection for postoperative pain relief in key hole surgeries in children

Completed

• Conditions: Cholelithiasis, (2) ICD-10 Condition: Q531||Undescended testicle, unilateral, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (4) ICD-10 Condition: K36||Other appendicitis,

• Registration Number: CTRI/2017/06/008729
• Lead Sponsor: Department of Anaesthesia Seth GS medical college and KEM hospital

Brief Summary

**SUMMARY**

Althoughabdominal laparoscopic surgery is known for less pain compared to that oflaparotomy, many patients actually still complain of considerable postoperativepain. Pain after laparoscopic surgeries is caused by the incision andvisceroperitoneal pain due to peritoneal stretch and inflammation. A promisingapproach to the provision of postoperative analgesia after abdominal surgery isto block the sensory nerve supply to the anterior abdominal wall by placing alocal anaesthetic in the transversus abdominis plane. The TAP block was firstdescribed by McDonell and colleagues in 2004 and a USG guided technique wassubsequently described by Hebbard and colleagues. USG guided TAP block providesexcellent pain relief in lower abdominal surgeries. The purpose of this studyis to evaluate the analgesic efficacy of USG guided TAP block in childrenundergoing laparoscopic surgeries.

Afterobtaining ethical clearance from the institutional review board, the study willbe carried out in 72 patients posted for laparoscopic surgeries like herniarepair, orchidopexy, appendicectomy and cholecystectomy in Paediatric SurgeryOT. The patients will be divided into two groups after induction ofanaesthesia:

Group A: Patients will receive bilateral TAP block under USGguidance using 0.4ml/kg 0.25% Inj. Bupivacaine.

Group B: Patients will receive local infiltration at the portusing 0.4ml/kg 0.25% Inj. Bupivacaine.

Inj Paracetamol 15mg/kg will be given intravenously in bothgroups at the beginning of surgery. Parameters recorded will be: Intraoperativelyhemodynamics i.e. heart rate and blood pressure monitoring every 15minutes andtotal dose of opioid required. Postoperatively assessment of pain: Wong BakerFACES scale, duration of analgesia and adverse effects. Thepain score will be assessed at 10min, 30mins, 1hour and hourly thereafter up to6 hours post operatively.Inj. Diclofenac 1.5mg/kg will be given as rescue analgesic post operatively ifthe Wong Baker’s FACES score is more than 4.

**Statistical analysis:** Statistical analysis of thedemographic data will be done using Chi-square test. The continuous outcomeswill be measured using the Student’s t test or the Mann Whitney U test. A pvalue<0.05 will be considered significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-04
• Study Completion: 2018-08-19
• Last Update Posted: 2024-02-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1.ASA I and II patients posted for elective laparoscopic surgeries in Paediatric surgery OT 2.Age between 2-12 years of both sexes 3.Children undergoing laparoscopic appendicectomy, hernia repair, cholecystectomy, and orchidopexy.

Exclusion Criteria

• 1.Refusal by the parent to participate in the study 2.Children in whom TAP block is contraindicated i.e. surgical scar or distorted anatomy at the site of injection.
• 3.Children with known allergy to local anaesthetics.
• 4.Children with known cardiovascular, respiratory, hepatic or renal disease 5.Laparoscopy converted to open surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain relief	The pain score will be assessed at 10min, 30mins, 1hour and hourly thereafter up to 6 hours post operatively

Secondary Outcome Measures

Name	Time	Method
Opioid Requirement	intraoperatively
Intraoperative Hemodynamics	at 5, 15, 30, 45 and 60 mins Intraoperatively

Trial Locations

Locations (1)

Seth G.S. medical college; 🇮🇳 Mumbai, MAHARASHTRA, India

Seth G.S. medical college

🇮🇳Mumbai, MAHARASHTRA, India

Dr Nandini Dave

Principal investigator

9819392094

nandinidave@gmail.com