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Investigating the effectiveness of intra-articular injection painkillers after cruciate ligament surgery

The Comparison between intraarticular knee injection (Morphine, ketorolac) with and without Tranxamic acid following arthroscopic ACL reconstruction surgery in reducing pain and assessing functional outcomes in patient with isolated ACL injury

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221230056983N1
Enrollment
100
Registered
2023-02-25
Start date
2022-04-01
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

isolated anterior cruciate ligament injury. Sprain and strain involving (anterior)(posterior) cruciate ligament of knee

Interventions

Intervention 1: Control group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc),100 mg of lidocaine (
All made by Iranian pharmaceutical companies. Intervention 2: Intervention group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg
All made by Iranian pharmaceutical companies.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 60 Years

Inclusion criteria

Inclusion criteria: an isolated, unilateral, chronic ACL tear Ability to read and write to give informed written consent and cooperate in the study Use of hamstring autograft American Society of Anesthesiologists (ASA) physical status of I

Exclusion criteria

Exclusion criteria: Drug sensitivity multi-ligament injuries bilateral ACL tears acute ACL tears bony deformities a history of hematologic conditions or ischemic attacks patients receiving anticoagulant therapy

Design outcomes

Primary

MeasureTime frame
Pain variables including the amount of pain based on Visual Analogue Scale (VAS). Timepoint: The pain level of the patients is based on the Visual Analoque Scale or VAS with a score from 1 to 10, which is measured in the intervals of one hour, two hours, 3 hours, 6 hours, 12 hours, one week, one month and three months after the operation. Method of measurement: The level of patient satisfaction are measured based on the Visual Analogue Scale index.;Functional variables in patients including Knee Injury and Osteoarthritis Outcome Score (KOOS). Timepoint: It is measured before surgery, one month and three months after surgery. Method of measurement: The score of the KOOS or Knee injury and Osteoarthritis Outcome Score questionnaire examines the patient in 5 areas and its score is 0 to 100%.

Secondary

MeasureTime frame
Functional variables in patients including Lysholm. Timepoint: Lysholm questionnaire score from 0 to 100, before surgery, one hour, one month and three months after surgery. Method of measurement: The performance of all patients is completed and evaluated based on the Lysholm questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehzad Nezhad Tabrizi

Tehran University of Medical Sciences

tabrizibehzad@gmail.com009892166581653

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026