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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07064993
Acronym
KATD-PAIN
Enrollment
135
Registered
2025-07-15
Start date
2026-07-15
Completion date
2027-04-30
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroscopy, Postoperative Pain

Keywords

Knee Arthroscopy, Postoperative Pain, Intraarticular Injection, Tramadol, Dexamethasone, Analgesia, Randomized Controlled Trial

Brief 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. 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.

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.

Interventions

DRUGSaline

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

DRUGTramadol

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

DRUGTramadol + Dexamethasone

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.

Sponsors

Arzu Esen Tekeli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

All study solutions will be prepared by an independent investigator and administered in identical syringes. Patients, surgeons, anesthesiologists, and outcome assessors will be blinded to group allocation.

Intervention model description

Prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain intensity - Area Under the Curve (VAS AUC 0-24 hours)0, 2, 6, 12, 24 hours postoperativelyPain 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.

Secondary

MeasureTime frameDescription
Time to first analgesic requirementWithin 24 hours postoperativelyTime from the end of surgery to the first rescue analgesic administration will be recorded in minutes.
Total analgesic consumption24 hours postoperativelyTotal rescue analgesic (deksketoprofen) consumption during the first 24 hours after surgery will be recorded in milligrams.
Postoperative nausea severity (0-3 scale)24 hours postoperativelyNausea severity assessed using a 0-3 scale (0: none, 1: mild, 2: moderate, 3: severe) within the first 24 hours postoperatively.
Number of vomiting episodes24 hours postoperativelyThe number of postoperative vomiting episodes will be recorded within the first 24 hours after surgery.
Postoperative itching severity (0-3 scale)24 hours postoperativelyItching severity assessed using a 0-3 scale (0: none, 1: mild, 2: moderate, 3: severe) within the first 24 hours postoperatively.
Postoperative shivering severity (0-3 scale)24 hours postoperativelyShivering severity assessed using a 0-3 scale (0: none, 1: mild, 2: moderate, 3: severe) within the first 24 hours postoperatively.
Adverse eventsUp to 30 days postoperativelyAdverse events will be recorded as follows: nausea, vomiting, itching, and shivering within the first 24 hours postoperatively; and joint infection within 30 days postoperatively.

Countries

Turkey (Türkiye)

Contacts

CONTACTArzu Esen Tekeli, MD
esentekeli190807@hotmail.com+905053756375
CONTACTDoğukan Çatulay, MD
dctly9292@gmail.com05556880881
STUDY_CHAIRŞükran Sevimli, PhD

Van Yuzuncu Yil University Ethics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026