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Opioid AnalgesiaNCT06812169

The Effect of Tap Block in Pain Relief in Pediatric Patients

An observational study of Opioid Analgesia and Pain, Postoperative, run by Arnavutkoy State Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 16 yearsHealthy volunteers can take part
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jun 2022to 1 Nov 2022
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Arnavutkoy State Hospital

    Istanbul, Arnavutkoy, 34090

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Keywords
TAP Block
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06812169
Study groupRoleWhat they receive
Group STAP block was applied to this group of open appendectomy patients.
Group CTAP block was not applied to this group of open appendectomy patients.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Rescue analgesic consumption

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start15 Jun 2022
  3. Primary completion15 Oct 2022
  4. Study completion1 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
60 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06812169
Sponsor's protocol ID
GK-TAP-GAZ
Status last verified
Jan 2025
First submitted
1 Feb 2025
Last updated
6 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22834467
  • 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.

    PubMed 30881907
  • 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.

    PubMed 20802056
  • 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.

    PubMed 19561014

Questions about this trial

What is this clinical trial studying?

An observational study of Opioid Analgesia and Pain, Postoperative, run by Arnavutkoy State Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect on pain score (time frame: At 0, 1, 3, 6, 12 and 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06812169, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.

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