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

NCT07064993 | Not Yet Recruiting Phase 4

• 1 other identifier: 19.11.2024
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroscopy; Postoperative Pain

Keywords

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

Outcome Measures

Primary Outcomes (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.

  0, 2, 6, 12, 24 hours postoperatively

Secondary Outcomes (7)

• Time to first analgesic requirement

  Within 24 hours postoperatively

• Total analgesic consumption

  24 hours postoperatively

• Postoperative nausea severity (0-3 scale)

  24 hours postoperatively

• Number of vomiting episodes

  24 hours postoperatively

• Postoperative itching severity (0-3 scale)

  24 hours postoperatively

Study Arms (3)

Placebo Group

PLACEBO COMPARATOR

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

Drug: Saline

Tramadol Group

EXPERIMENTAL

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

Drug: Tramadol

Tramadol + Dexamethasone Group

EXPERIMENTAL

Patients 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.

Drug: Tramadol + Dexamethasone

Interventions

Saline DRUG

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

Placebo Group

Tramadol DRUG

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

Tramadol Group

Tramadol + Dexamethasone DRUG

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.

Tramadol + Dexamethasone Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Arzu Esen Tekeli: lead

Study Sites (1)

Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation

Van, 65100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Sodium Chloride; Tramadol; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Şükran Sevimli, PhD

  Van Yuzuncu Yil University Ethics

  STUDY CHAIR

Central Study Contacts

Arzu Esen Tekeli, MD

CONTACT

+905053756375; esentekeli190807@hotmail.com

Doğukan Çatulay, MD

CONTACT

05556880881; dctly9292@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

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

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: July 15, 2025
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)