NCT06812169

Brief Summary

TAP block applied for analgesic purposes in pediatric patients undergoing appendectomy surgery provides superior analgesia in analgesic relief in the first 24 hours postoperatively compared to the placebo-control group without any block. The objective of this study was to investigate the postoperative analgesic effectiveness of TAP block based on postoperative pain scores in pediatric patients undergoing appendectomy surgery. This study is valuable because of there are a limited number of studies in this field in pediatric patients in the literature.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
Last Updated

February 6, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

February 1, 2025

Last Update Submit

February 1, 2025

Conditions

Opioid AnalgesiaPain, PostoperativePain Score Reduction

Keywords

TAP Block

Outcome Measures

Primary Outcomes (1)

  • Effect on pain score

    Wong-Baker FACE Scale scores of patients were measured at 0, 1, 3, 6, 12 and 24 hours after surgery. Wong Baker FACE scale score will be scored as 10 at the highest and 1 at the lowest. The Turkish version has been adjusted for pediatric patients.

    At 0, 1, 3, 6, 12 and 24 hours after surgery

Secondary Outcomes (1)

  • Rescue analgesic consumption

    At 0, 1, 3, 6, 12 and 24 hours after surgery

Other Outcomes (1)

  • Parental satisfaction levels

    At 0, 1, 3, 6, 12 and 24 hours after surgery

Study Arms (2)

Group S

TAP block was applied to this group of open appendectomy patients.

Group C

TAP block was not applied to this group of open appendectomy patients.

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients aged between 5 and 16 years who were scheduled for elective open appendectomy surgery under general anesthesia were included in the study.

You may qualify if:

  • Those who have had surgery for acute appendicitis ASA status I-II

You may not qualify if:

  • ASA III-IV Perforated appendectomies Laparoscopic cases Patients allergic to local anesthetic drugs. Bleeding diathesis Skin infection at the needle entry site Those who refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arnavutkoy State Hospital

Istanbul, Arnavutkoy, 34090, Turkey (Türkiye)

Location

Related Publications (4)

  • Mai CL, Young MJ, Quraishi SA. Clinical implications of the transversus abdominis plane block in pediatric anesthesia. Paediatr Anaesth. 2012 Sep;22(9):831-40. doi: 10.1111/j.1460-9592.2012.03916.x.

    PMID: 22834467BACKGROUND

  • Seyedhejazi M, Motarabbesoun S, Eslampoor Y, Taghizadieh N, Hazhir N. Appendectomy Pain Control by Transversus Abdominis Plane (TAP) Block in Children. Anesth Pain Med. 2019 Feb 20;9(1):e83975. doi: 10.5812/aapm.83975. eCollection 2019 Feb.

    PMID: 30881907BACKGROUND

  • Carney J, Finnerty O, Rauf J, Curley G, McDonnell JG, Laffey JG. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial. Anesth Analg. 2010 Oct;111(4):998-1003. doi: 10.1213/ANE.0b013e3181ee7bba. Epub 2010 Aug 27.

    PMID: 20802056BACKGROUND

  • Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.

    PMID: 19561014BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Anesthesiology

Study Record Dates

First Submitted

February 1, 2025

First Posted

February 6, 2025

Study Start

June 15, 2022

Primary Completion

October 15, 2022

Study Completion

November 1, 2022

Last Updated

February 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)