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Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery

A

Abdelrady S Ibrahim, MD

Status and phase

Completed
Phase 2

Conditions

Postoperative Pain

Treatments

Drug: Bupivacaine 0.125%
Drug: Bupivacaine 0.25%

Study type

Interventional

Funder types

Other

Identifiers

NCT02723487
17100390

Details and patient eligibility

About

The primary objective of this study is to assess differences in postoperative pain experienced by pediatric patients having transversus abdominis plane block block with bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv analgesia after Laparoscopic surgery.

Full description

A prospective randomized controlled double blind study using a computer generated randomization will be conducted in Assiut University Hospitals and carried on 60 pediatric patients undergoing laparoscopic surgery under general anesthesia.

After induction of general anesthesia and endotracheal intubation, patients in group B and group C will be placed in the supine position and transversus abdominis plane block will be performed under ultrasound guidance. After skin preparation, the linear ultrasound probe connected to a portable ultrasound unit will be placed in the axial plane across the mid-axillary line midway between the costal margin and the highest point of iliac crest. needle attached to a syringe filled with the Local anesthetic solution will be inserted until it reaches the plane between the internal oblique and transversus abdominis muscles.

After careful aspiration to exclude vascular puncture, injection of bupivacaine will be performed leading to separation between the internal oblique and the transversus abdominis muscles which will appear as a hypoechoic space on ultrasound. This procedure will be repeated on the opposite side .

Laparoscopic procedure will be started 20 minutes after completion of bilateral transversus abdominis plane block and 0.01 mg/kg iv atropine will be given before pneumoperitonem. Intra abdominal pressure will be maintained at 10-12 mmHg.

The use of opioids during the procedure will based on the cardiovascular response to stimulation; a heart rate increase of 20% from baseline will be interpreted as insufficient analgesia and will be treated with fentanyl in doses of 1mcg / kg.

Enrollment

60 patients

Sex

Male

Ages

1 to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ASA I-II physical status patients.
  • Genders Eligible for Study :male.
  • All children scheduled for laparoscopic surgery between the ages of 1and 5 years.
  • Duration of Laparoscopic procedure not exceeding 90 minutes.
  • Written informed consent from parent of guardian .

Exclusion criteria

  • Sensitivities to local anesthetics.
  • Significant renal, liver, or cardiac disease.
  • Surgery requiring an open procedure

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups

Group A
No Intervention group
Description:
Control
Group B
Active Comparator group
Description:
patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side.
Treatment:
Drug: Bupivacaine 0.125%
Group C
Active Comparator group
Description:
patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side.
Treatment:
Drug: Bupivacaine 0.25%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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