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Knee ArthroscopyPhase 4KATD-PAINNCT07064993

Effects of Intraarticular Tramadol and Tramadol-Dexamethasone on Postoperative Pain After Knee Arthroscopy

A Phase 4 study testing Saline, Tramadol and Tramadol + Dexamethasone in people with Knee Arthroscopy and Postoperative Pain, run by Arzu Esen Tekeli at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Patients scheduled for elective knee arthroscopy under general anesthesia will be randomly assigned into three groups in a 1:1:1 ratio: placebo (saline), tramadol, and tramadol plus dexamethasone. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Knee Arthroscopy, Postoperative Pain
What is being tested?
Saline, Tramadol and Tramadol + Dexamethasone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jul 2026to 30 Apr 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18-65 years ASA physical status I-II Scheduled for elective knee arthroscopy under general anesthesia Only minor arthroscopic procedures such as partial meniscectomy will be included Ability to provide informed consent

Who cannot join

  • Allergy or contraindication to tramadol or dexamethasone Chronic opioid use or chronic pain conditions History of psychiatric or neurological disorders that may affect pain perception Severe hepatic or renal impairment Pregnancy or breastfeeding Infection at the injection site Bleeding diathesis Refusal to participate Major reconstructive knee surgeries (e.g., anterior cruciate ligament reconstruction)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Arzu Esen Tekeli, MD contact

+905053756375

esentekeli190807@hotmail.com

Doğukan Çatulay, MD contact

05556880881

dctly9292@gmail.com

Turkey (Türkiye)1 site
  • Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation

    Van, 65100

Other trials in Turkey (Türkiye)

About this study

Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Effects of Intraarticular Tramadol and Tramadol Plus Dexamethasone on Postoperative Pain After Knee Arthroscopy

Patients scheduled for elective knee arthroscopy under general anesthesia will be randomly assigned into three groups in a 1:1:1 ratio: placebo (saline), tramadol, and tramadol plus dexamethasone. At the end of surgery, after aspiration of the irrigation fluid, the study solution will be administered intraarticularly in a standardized volume.

The primary outcome is the area under the curve (AUC) of VAS scores measured at 0, 2, 6, 12, and 24 hours postoperatively (VAS AUC 0-24h). Secondary outcomes include time to first analgesic requirement, total analgesic consumption within 24 hours, and the incidence of adverse effects such as nausea, vomiting, itching, and shivering.

This study aims to determine whether intraarticular tramadol provides effective postoperative analgesia and whether the addition of dexamethasone enhances this analgesic effect.

Read the detailed description

Postoperative pain remains a significant concern following knee arthroscopy, even in minimally invasive procedures. Various intraarticular agents have been investigated to improve postoperative analgesia, reduce opioid consumption, and enhance patient comfort. Tramadol, a centrally acting analgesic with additional peripheral effects, has been shown to provide analgesia when administered intraarticularly. Dexamethasone, a corticosteroid with anti-inflammatory properties, may enhance analgesic efficacy when used as an adjuvant.

This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the postoperative analgesic effects of intraarticular tramadol and tramadol combined with dexamethasone in patients undergoing elective knee arthroscopy.

A total of 120-135 patients aged 18-65 years with ASA physical status I-II scheduled for knee arthroscopy under general anesthesia will be included. Patients will be randomly assigned into three groups in a 1:1:1 ratio using a computer-generated block randomization method.

At the end of the surgical procedure, after aspiration of the irrigation fluid and before closure of the portal, the study solutions will be administered intraarticularly in a standardized volume of 20 mL. The groups will be as follows: placebo (normal saline), tramadol (100 mg), and tramadol (100 mg) combined with dexamethasone (8 mg). All study solutions will be prepared by an independent investigator in identical syringes to ensure blinding of patients, surgeons, anesthesiologists, and outcome assessors.

All patients will receive standardized general anesthesia and postoperative analgesia protocols. VAS at 0 hour is measured only when Ramsay Sedation Score ≤3. Total irrigation volume (L) is recorded.Intraoperative analgesia is standardized: fentanyl 1 mcg/kg at induction, additional 0.5 mcg/kg as needed (max 3 mcg/kg total). All patients receive IV paracetamol 15 mg/kg before extubation. Total intraoperative fentanyl dose is recorded.

The primary outcome is the area under the curve (AUC) of VAS scores measured at 0, 2, 6, 12, and 24 hours postoperatively (VAS AUC 0-24h). Rescue analgesia will be administered as IV dexketoprofen 50 mg if VAS ≥4. Pain will be reassessed after 30 minutes; if VAS remains ≥4, a second dose may be administered. The minimum interval between doses will be 30 minutes, with a maximum total dose of 150 mg within 24 hours. Total dexketoprofen consumption will be recorded. Secondary outcomes include time to first analgesic requirement, total analgesic consumption within 24 hours, and the incidence and severity of adverse effects such as nausea, vomiting, itching, shivering, and potential complications.

This study aims to determine whether intraarticular tramadol provides effective postoperative analgesia and whether the addition of dexamethasone enhances this effect, thereby contributing to improved postoperative pain management strategies in knee arthroscopy. To ensure procedural homogeneity, only minor arthroscopic procedures such as partial meniscectomy will be included, while major reconstructive procedures (e.g., anterior cruciate ligament reconstruction) will be excluded.

Being tested
Saline, Tramadol, Tramadol + Dexamethasone
Keywords
Knee Arthroscopy, Postoperative Pain, Intraarticular Injection, Tramadol, Dexamethasone, Analgesia, Randomized Controlled Trial
Medical subject headings
Pain, Postoperative, Agnosia

What participants receive

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

  • SalineDrug

    20 mL of normal saline administered intraarticularly at the end of surgery.

  • TramadolDrug

    Tramadol 100 mg diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.

  • Tramadol + DexamethasoneDrug

    Tramadol 100 mg combined with dexamethasone 8 mg diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.

Study groups in NCT07064993
Study groupRoleWhat they receive
Placebo GroupPlacebo comparatorPatients will receive 20 mL of normal saline administered intraarticularly at the end of surgery.
Receives: Drug: Saline
Tramadol GroupExperimentalPatients will receive 100 mg tramadol diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.
Receives: Drug: Tramadol
Tramadol + Dexamethasone GroupExperimentalPatients will receive 100 mg tramadol combined with 8 mg dexamethasone diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.
Receives: Drug: Tramadol + Dexamethasone

What is being measured

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

  1. Postoperative pain intensity - Area Under the Curve (VAS AUC 0-24 hours)

    Pain intensity is assessed using a 0-10 Visual Analog Scale (VAS) at 0, 2, 6, 12, and 24 hours postoperatively. The primary outcome is the area under the curve (AUC) calculated from these five time points using the trapezoidal rule. AUC represents the total pain burden over the first 24 hours.

    Measured: 0, 2, 6, 12, 24 hours postoperatively

Secondary outcomes (7)
  1. Time to first analgesic requirement

    Time from the end of surgery to the first rescue analgesic administration will be recorded in minutes.

    Measured: Within 24 hours postoperatively

  2. Total analgesic consumption

    Total rescue analgesic (deksketoprofen) consumption during the first 24 hours after surgery will be recorded in milligrams.

    Measured: 24 hours postoperatively

  3. Postoperative nausea severity (0-3 scale)

    Nausea severity assessed using a 0-3 scale (0: none, 1: mild, 2: moderate, 3: severe) within the first 24 hours postoperatively.

    Measured: 24 hours postoperatively

  4. Number of vomiting episodes

    The number of postoperative vomiting episodes will be recorded within the first 24 hours after surgery.

    Measured: 24 hours postoperatively

  5. Postoperative itching severity (0-3 scale)

    Itching severity assessed using a 0-3 scale (0: none, 1: mild, 2: moderate, 3: severe) within the first 24 hours postoperatively.

    Measured: 24 hours postoperatively

  6. Postoperative shivering severity (0-3 scale)

    Shivering severity assessed using a 0-3 scale (0: none, 1: mild, 2: moderate, 3: severe) within the first 24 hours postoperatively.

    Measured: 24 hours postoperatively

  7. Adverse events

    Adverse events will be recorded as follows: nausea, vomiting, itching, and shivering within the first 24 hours postoperatively; and joint infection within 30 days postoperatively.

    Measured: Up to 30 days postoperatively

Timeline

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

  1. First posted15 Jul 2025
  2. Study start15 Jul 2026 (estimated)
  3. Primary completion26 Feb 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07064993
Sponsor's protocol ID
19.11.2024
Acronym
KATD-PAIN
Status last verified
May 2026
First submitted
10 Feb 2025
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Saline, Tramadol and Tramadol + Dexamethasone in people with Knee Arthroscopy and Postoperative Pain, run by Arzu Esen Tekeli 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: opening soon, as of the sponsor's last update on 14 May 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Arzu Esen Tekeli, MD (+905053756375, esentekeli190807@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain intensity - Area Under the Curve (VAS AUC 0-24 hours) (time frame: 0, 2, 6, 12, 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 May 2026.

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