Effects of Intraarticular Tramadol and Tramadol-Dexamethasone on Postoperative Pain After Knee Arthroscopy (KATD-PAIN)

Arzu Esen Tekeli

Status and phase: Begins enrollment this month; Phase 4

Conditions: Postoperative Pain; Knee Arthroscopy

Treatments: Drug: Tramadol + Dexamethasone; Drug: Saline; Drug: Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT07064993

19.11.2024

Details and patient eligibility

About

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 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 of the study is postoperative pain intensity assessed by the Visual Analog Scale (VAS). 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.

Full 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. Pain intensity will be assessed using the Visual Analog Scale (VAS) at predetermined time points (0, 2, 6, 12, and 24 hours postoperatively). Rescue analgesia will be administered when VAS ≥ 4, and total analgesic consumption will be recorded.

The primary outcome of the study is postoperative pain intensity assessed by the Visual Analog Scale (VAS) at 0, 2, 6, 12, and 24 hours postoperatively. 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, 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 and diagnostic arthroscopy will be included, while major reconstructive procedures (e.g., anterior cruciate ligament reconstruction) will be excluded.

Enrollment: 135 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 and diagnostic arthroscopy 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

135 participants in 3 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline

Tramadol Group

Experimental group

Description:

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

Treatment:

Drug: Tramadol

Tramadol + Dexamethasone Group

Experimental group

Description:

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.

Treatment:

Drug: Tramadol + Dexamethasone