NCT06230081

Brief Summary

The purpose of this study is to evaluate the effect on postoperative pain, opioid consumption and function by adding a combination of regional blocks with local anaesthetic before total hip- and knee arthroplasty compared to standard pain management strategies.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

January 4, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2026

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

January 4, 2024

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference in Postoperative pain assessed by NRS

    Patient experienced postop pain assessed by NRS (0-10)

    The day of surgery, postop day 1 and 14 days post-surgery

Secondary Outcomes (8)

  • Difference in analgesia consumption

    The day of surgery, postop day 1 and 14 days post-surgery

  • Time to mobilization

    The day of surgery, postop day 1

  • Incidence of postoperative nausea and vomiting

    The day of surgery, postop day 1

  • Difference in postoperative pain depending on method of anesthesia

    The day of surgery, postop day 1 and 14 days post-surgery

  • urine catheter usage

    1-5 days post-surgery

  • +3 more secondary outcomes

Study Arms (2)

Block

ACTIVE COMPARATOR

Hip Arthroplasty: Multimodal analgesic therapy + Ultrasound guided PENG block and Iliohypogastric block or LFCN-block. Knee arthroplasty: Multimodal analgesic therapy + Ultrasound guided iPACK block, triple Genicular blocks, Vastus intermedius block, Adductor canal block and AFCN-block.

Drug: Ropivacain 5 mg/ml + Clonidine

No block

NO INTERVENTION

Hip Arthroplasty: Multimodal analgesic therapy Knee Arthroplasty: Multimodal analgesic therapy + LIA

Interventions

Drug used in the block

Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoarthritis of the knee- or hip necessitating total knee- or hip replacement
  • Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

You may not qualify if:

  • Known allergy to local anesthetics or other contraindication for the use of local anesthetics.
  • Coagulopathy
  • Bilateral operation
  • Revision arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Anaesthesiology, Trelleborg Hospital

Trelleborg, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Clonidine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gunnar Flivik, MD PhD

    Department of Orthopedics, Skane Univ Hosp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Nurses and physiotherapists evaluating the patients are blinded as well as the physician compiling the data
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients are randomized to either block or no block therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 30, 2024

Study Start

February 1, 2024

Primary Completion

March 30, 2025

Study Completion

April 26, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

General unidentified data and study protocol are available on request

Locations