Open TAP-block in Pediatric Abdominal Surgery

TAP-blockad Vid öppen Bukkirurgi Hos Barn

The goal of this trial is to evaluate an open TAP-block vs continuous administration of local anestetic via a wound catheter for postoperative pain management in patients 1-15 years of age undergoing open abdominal surgery.

Study Overview

• Status: Recruiting
• Conditions: Pain Management After Surgery
• Intervention / Treatment: Procedure: TAP-block; Procedure: Wound catheter

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oskar Nensén, MD, PhD; Phone Number: +46186110000; Email: oskar.nensen@uu.se
• Study Contact Backup: Name: Niclas Högberg, MD, PhD; Phone Number: +46186110000; Email: niclas.hogberg@uu.se

Study Locations

• Sweden
  • Uppsala, Sweden, 75123
    • Recruiting
    • Akademiska sjukhuset
    • Contact: Sofia Arwhed, MD, PhD; Email: sofia.arwehed@regionuppsala.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 1-15 years
• Scheduled for elective or acute open adominal surgical procedure

Exclusion Criteria:

• chronic abdominal pain
• known allergy to local analgetic
• Stage 4 renal failure
• psychiatric ailnment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP-block; Subjects in the TAP-block arm will recieve an open TAP-block at the end of the procedure vbefore wound closure	Procedure: TAP-block; Open TAP(transverse abdominal plane)-block placed by the surgeon using open technique at end of surgery before wound closure
Active Comparator: Wound infiltration; Subjects in the wound infiltration group will recieve contionious administration of local anastethic via a wound catheter placed subcutaneousley during wound closure.	Procedure: Wound catheter; A catheter placed subcutainiousley for the continuous administration of local anestethic in the wound for up to 3 days post-op

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opiates	Amount of postoperative opiates administered	during the first 24 hours following surgery and total opioids until discarge up to 14 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lenght of stay	Duration of hospital stay	Days from surgery through study completeion, an average expected time of7 days
Pain assessment	Pain assesment using validated instruments, FLACC or FPS-R	End of surgery until 24 hours post-op

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Oskar Nensén, MD, PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: pediatric; TAP-block; postoperative pain management
• Other Study ID Numbers: NOR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD (anonymized) underlying data in a future publication will be made available on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No