Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery.

Phase 2

• Conditions: Analgesia
• Interventions: Procedure: TAB Block; Procedure: Psoas Block; Drug: Bupivacaine

• Registration Number: NCT03388671
• Lead Sponsor: Assiut University

Brief Summary

The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas block blockade. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.

Detailed Description

Transversus abdominis plane (TAP) block is a promising effective method for postoperative pain control after major abdominal surgery. TAP block provides analgesia by inhibiting nerve conduction from the anterior abdominal wall arising from the intercostal nerves, subcostal nerves, and first lumbar nerve (T6-L1). Using a landmark technique, it is easily performed, but its popularity has decreased because of reduced efficacy due to inaccurate injection and the potential for intra-peritoneal organ damage. Ultrasound-guided TAP block provides better results and fewer complications, but it requires experienced operators. Surgically administered TAP (sTAP) block guided by the video camera of the laparoscope is a simple technique and may cause no complications. Also, under laparoscopic guidance, block of ilioinguinal, iliohypogastric, and genitofemoral nerves can be possible with anesthetic injection in the plane between psoas major and the fasciae covering its anterior aspects \[laparoscopic-assisted psoas (LAP) blockade\].

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-25
• Study First Submitted: 2017-12-25
• Study First Submitted QC: 2017-12-25
• Study First Posted: 2018-01-03
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Children (1-6 years) of both sexes undergoing elective laparoscopic surgeries that last >30minutes (eg. undescended testis and inguinal hernia repair).
• Written consent, free and informed

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Exclusion Criteria

• Significant respiratory, cardiac or renal disease
• BMI >95th percentile for age.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAB Block	TAB Block	Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Transversus abdominis plane block.
Psoas Block	Psoas Block	Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided psoas block.
TAB Block	Bupivacaine	Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Transversus abdominis plane block.
Psoas Block	Bupivacaine	Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided psoas block.

Primary Outcome Measures

Name	Time	Method
FLACC PAIN score	36hours	postoperative FLACC pain scores.

Trial Locations

Locations (1)

Pediatric hospital, faculty of medicine, Assiut university; 🇪🇬 Assiut, Assiut Governorate, Egypt