NCT07352683

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
45mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Dec 2025Jan 2030

Study Start

First participant enrolled

December 1, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

December 2, 2025

Last Update Submit

January 12, 2026

Conditions

Keywords

pediatricTAP-blockpostoperative pain management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Lenght of stay

    Days from surgery through study completeion, an average expected time of7 days

  • Pain assessment

    End of surgery until 24 hours post-op

Study Arms (2)

TAP-block

EXPERIMENTAL

Subjects in the TAP-block arm will recieve an open TAP-block at the end of the procedure vbefore wound closure

Procedure: TAP-block

Wound infiltration

ACTIVE COMPARATOR

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

Interventions

TAP-blockPROCEDURE

Open TAP(transverse abdominal plane)-block placed by the surgeon using open technique at end of surgery before wound closure

TAP-block

A catheter placed subcutainiousley for the continuous administration of local anestethic in the wound for up to 3 days post-op

Wound infiltration

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akademiska sjukhuset

Uppsala, 75123, Sweden

RECRUITING

Study Officials

  • Oskar Nensén, MD, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oskar Nensén, MD, PhD

CONTACT

Niclas Högberg, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2025

First Posted

January 20, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

IPD (anonymized) underlying data in a future publication will be made available on request.

Locations