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

NCT ID: NCT03388671

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-25

Study Completion Date

2020-12-31

Brief Summary

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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

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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 \[laparoscopic-assisted psoas (LAP) blockade\].

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The data collection personnel and the patients' guardians will be blinded to the group assignment.

Study Groups

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TAB Block

Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Transversus abdominis plane block.

Group Type ACTIVE_COMPARATOR

TAB Block

Intervention Type PROCEDURE

patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided TAB Block

Bupivacaine

Intervention Type DRUG

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

Psoas Block

Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided psoas block.

Group Type ACTIVE_COMPARATOR

Psoas Block

Intervention Type PROCEDURE

patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block

Bupivacaine

Intervention Type DRUG

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

Interventions

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TAB Block

patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided TAB Block

Intervention Type PROCEDURE

Psoas Block

patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block

Intervention Type PROCEDURE

Bupivacaine

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

Intervention Type DRUG

Other Intervention Names

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Bucain

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Hala Saad Abdel-Ghaffar

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hala S Abdelghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.

Locations

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Pediatric hospital, faculty of medicine, Assiut university

Asyut, Assiut Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hala S Abdelghaffar, MD

Role: CONTACT

01003812011 ext. +2088

Seham M Moeen, MD

Role: CONTACT

01006386324 ext. +2088

Facility Contacts

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Hala S Abdelghaffar, MD

Role: primary

+201003812011

Seham M Moeen, MD

Role: backup

01006386324

Other Identifiers

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17300080

Identifier Type: -

Identifier Source: org_study_id

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