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NCT03388671 Clinical Trial

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

Analgesia Clinical Trial

— TAB  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03388671
Other study ID # 17300080
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date December 25, 2017
Est. completion date December 2020

Study information
Verified date July 2020
Source Assiut University
Contact Hala S Abdelghaffar, MD
Phone 01003812011
Email hallasaad@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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].

Recruitment information / eligibility
Status Recruiting
Enrollment 44
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 6 Years
Eligibility 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

Exclusion Criteria:

- Significant respiratory, cardiac or renal disease

- BMI >95th percentile for age.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• TAB Block
patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided TAB Block
• Psoas Block
patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block
Drug:
• Bupivacaine
patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block or TAB block

Locations
Country Name City State
Egypt Pediatric hospital, faculty of medicine, Assiut university Assiut Assiut Governorate

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary FLACC PAIN score postoperative FLACC pain scores. 36hours
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