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Peri-articular multimodal cocktail drug injection after ACLR

Peri-articular with Peri-Hamstring injection for pain control after Anterior Cruciate Ligament reconstruction: Bupivacaine/Ketorolac/Adrenaline versus Placebo, A randomized controlled trial, double-blinded study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210216002
Enrollment
40
Registered
2021-02-16
Start date
2021-06-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

post operative pain after Anterior Cruciate Ligament Reconstruction surgery with Hamstring graft. ACL Reconstruction pain control peri-articular injection multimodal cocktail drug

Interventions

Multimodal cocktail drug consists of 0.5% Bupivacaine 100 mg, Ketorolac 30 mg, Adrenaline 0.2 mg and normal saline solution 37 ml. (total volume 60 ml). The multimodal cocktail drug will be injected
Experimental Drug,Placebo Comparator No treatment
Multimodal cocktail drug,Placebo

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed ACL injury that have to be performed ACLR (elective case) 2. Age 18 to 50 years 3. Normal Conciousness 4. Volunteer

Exclusion criteria

Exclusion criteria: 1. ASA classification more than 3 2. Have history drug allergy (Bupivacaine, NSAIDs, Opioid) 3. Have history of UGIB 4. Chronic Kidney Disease stage 3 or GFR < 60 ml/min/1.73 m2 5. Underlying disease Ishemic Heart Disease, Cardio Vascular Disease, Platelet disorder. Coagulopathy 6. Usage of anti-coagulant drug 7. Have contraindication for Spinal Anesthesia or neurologic disorder

Design outcomes

Primary

MeasureTime frame
pain at 0,6,12,24,48 hours after ACLR surgery Visual Analogue Pain score

Secondary

MeasureTime frame
IV Opioid drug use within 3 days after ACLR surgery amount of IV opioid drug use,functional score within 6 weeks after surgery IKDC score and Lysholm score,time to ambulation within 3 days after ACLR surgery time (hours),1st time IV Opioid use within 3 days after ACLR surgery time (hours),pain at 2 and 6 weeks after ACLR surgery Visual analogue pain score,range of motion of knee at 6 weeks after ACLR surgery degree,length of stay along admission admission days,Nausea/Vomiting within 3 days after ACLR surgery Nausea/Vomiting

Countries

Thailand

Contacts

Public ContactPhanusorn Chancharoenchai

King Chulalongkorn Memorial Hospital

phanusorn.c20@chula.md022565351

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026