The Effect of Tap Block in Pain Relief in Pediatric Patients

February 1, 2025 updated by: GOKHAN ASLAN, Arnavutkoy State Hospital

The Effectiveness of USG-guided Tap Block in Postoperative Pain Relief in Pediatric Patients Who Underwent Open Appendectomy with Mc-Burney Incision

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.

Study Overview

Detailed Description

This study was designed as prospectif, randomized, placebo-controlled, double-blind. A total of 60 pediatric patients, who were planned to undergo elective open appendectomy surgery under general anesthesia, were included in the study, with 30 patients in both groups eligible for the study. The patients were randomly divided into 2 groups. The randomisation in study was performed by using the closed envelope method. The TAP block was applied to Group I(Group S). The Group II(Group C) was patients who are not performed a block, and was taken as the control group. After all patients were taken to the operating table, ECG, non-invazive blood pressure, pulse oximetry and saturation monitoring were performed as the standard of ASA. During induction, 3mg/kg propofol, 1mg/kg fentanyl and 0.8 mg/ kg rocuronium were administered to all patients, then they were ventilated with 100% oxygen for 5 minutes and intubated with an appropriate intubation tube. After intubation in Grup S applied TAP block, the patients were covered with a sterile cleaned area, the transversus abdominis plane is visualized by placing the linear probe between the costal edge and the iliac wing, on the outer part of the abdominal wall, with a portable ultrasound device on the abdominal wall of the patients on the side to be repaired, and the external oblique muscle with the help of a 50 mm block needle. 0.25 % bupivacaine 0.5 ml/ kg maximum 20 ml was injected between the internal oblique and transverse muscles with in-plane tecnique. On the other hand, no blocks were applied to The Group C , and was taken as the control group. Anesthesia was maintained with 2% sevoflurane and 50% oxygen in air. Intravenous fluid maintenance was provied with isotonic-balanced electrolyte solution at 10 ml/kg/hour in both group. A maximum of 3 mg of morphine 50mcg/kg intravenously was given to all patients intraoperatively for analgesic purposes. At the end of the surgery, the patients were extubated under appropriate conditions.

Evaluation of postoperative pain; It was planned to be performed by a physician or a pain staff who did not perform the block, first in the postoperative recovery room and then in the ward, using The Wong-Baker Faces Pain Rating Scale (FACES Scale). The primary outcome of the study is The Wong-Baker Faces Pain Rating Scale (FACES Scale) scores of the patients, and the secondary outcomes are; time and amount of first additional rescue analgesic requirement, systolic-diastolic-mean arterial pressures, heart rate peaks and parental satisfaction scores. With predetermined time points; Postoperative baseline 0, 1st, 3rd, 6th, 12th and 24th hours of the patients' is The Wong-Baker FACE Scale scores, rescue analgesic totally amount, systolic-diastolic-mean arterial pressures, peak heart rates, and possible complications such as nausea and vomiting were recorded in both groups. Parental satisfaction levels were recorded on a numerical scale from 1 to 10 (1: lowest satisfaction, 10: highest satisfaction). If The Wong-Baker FACE Scale scores > 4, acetaminophen 10 mg/kg IV was planned to be administered as an additional rescue analgesic in the ward. In this study, power analysis was performed after the analysis results. Sample size was calculated by power analysis based on data from a previous study (12). In this study, researchers; They compared the analgesic effectiveness of the patients who applied TAP block and the placebo-control group in the first 48 hours postoperatively in a total of 60 patients who underwent pediatric appendectomy, and revealed that Tap block provided superior analgesia compared to the placebo group. Power estimation analysis suggested that add 30 individuals to each group and the power of the test was found to be p= 0.9035. The error level was taken as 0.05. In this study, when α= 0.05 β= 0.10 1-β = 0.90.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arnavutkoy
      • Istanbul, Arnavutkoy, Turkey, 34090
        • Arnavutkoy State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on pain score
Time Frame: At 0, 1, 3, 6, 12 and 24 hours after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescue analgesic consumption
Time Frame: At 0, 1, 3, 6, 12 and 24 hours after surgery
If the Wong-Baker FACE Scale score was > 4, 10 mg/kg IV paracetamol was planned to be administered as additional rescue analgesia in the ward.
At 0, 1, 3, 6, 12 and 24 hours after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental satisfaction levels
Time Frame: At 0, 1, 3, 6, 12 and 24 hours after surgery
Parental satisfaction levels were recorded on a numerical scale from 1 to 10 (1: lowest satisfaction, 10: highest satisfaction).
At 0, 1, 3, 6, 12 and 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

February 1, 2025

First Submitted That Met QC Criteria

February 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 1, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GK-TAP-GAZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

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