NCT07779473

Brief Summary

Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Arthroscopic Rotator Cuff Repair Surgery.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
37mo left

Started Jul 2026

Typical duration for all trials

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

Study Progress5%
Jul 2026Sep 2029

Study Start

First participant enrolled

July 1, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

3 years

First QC Date

July 24, 2026

Last Update Submit

August 19, 2026

Conditions

Arthroscopic Rotator Cuff Repair (ARCR)Postoperative PainChronic Pain

Keywords

Arthroscopic rotator cuff repairpostoperrative painchronic paintramadoltapentadol

Outcome Measures

Primary Outcomes (5)

  • Post-operative pain

    Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    6 hours after surgery

  • Post-operative pain

    Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    12 hours after surgery

  • Post-operative pain

    Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    1st postoperative day

  • Post-operative pain

    Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    2nd postoperative day

  • Post-operative pain

    Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    3rd postoperative day

Secondary Outcomes (51)

  • Post-operative pain

    3 weeks after surgery

  • Post-operative pain

    6 weeks after surgery

  • Post-operative pain

    3 months after surgery

  • Post-operative pain

    6 months after surgery

  • Neuropathic pain

    6 months after surgery

  • +46 more secondary outcomes

Study Arms (2)

Tramadol

Tramadol will be administered in a multimodal analgesic approach to manage postoperative pain.

Drug: Tramadol

Tapentadol

Tapentadol will be administered in a multimodal analgesic approach to manage postoperative pain.

Drug: Tapentadol

Interventions

TramadolDRUG

Add tapentadol, for effective pain management in a multimodal setting during ARCR

Tramadol
TapentadolDRUG

Add tramadol, for effective pain management in a multimodal setting during ARCR

Tapentadol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who will undergo arthroscopic rotator cuff surgery

You may qualify if:

  • Patients for elective ARCR
  • ASA PS I - III
  • Age 18-80 (adults)

You may not qualify if:

  • Patient refusal
  • Cognitive disfunction
  • Severe psychiatric disease
  • Under medication with MAO inhibitors, tricyclic antidepressants, serotonin reuptake inhibitors
  • Not speaking Greek
  • Known allergy to the study drugs
  • Contraindications for any of the study drugs
  • Chronic renal failure (GFR \< 50 ml/h)
  • Liver failure
  • Known regular use or misuse of opioids
  • Pregnant women
  • Patients undergoing general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Larissa University Hospital

Larissa, Thessaly, 41110, Greece

Location

MeSH Terms

Conditions

Pain, PostoperativeChronic Pain

Interventions

TramadolTapentadol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Eleni Arnaoutolglou, MD, PhD

    Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Principal Investigator

    STUDY CHAIR

  • Metaxia Bareka, MD, PhD

    Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Anesthesiology

Study Record Dates

First Submitted

July 24, 2026

First Posted

August 21, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

August 21, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)