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Periarticular Injection and Hamstring Block Versus Placebo for Pain Control in Anterior Cruciate Ligament Reconstruction

NCT05248724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-03-08

No results posted yet for this study

Summary

A randomized controlled trial about periarticular injection and hamstring block versus placebo for pain control in anterior cruciate ligament reconstruction

Conditions

  • Anterior Cruciate Ligament Reconstruction

Interventions

COMBINATION_PRODUCT

periarticular infiltration (50ml) with Ropivacaine Hydrochloride 10 MG/ML (200 mg) + ketorolac tromethamine 30 mg/ml (30 mg) + adrenaline 1mg/ml (300 microgram) + morphine hydrochloride 10mg/ml (5 mg)

Patients allocated to the intervention group received a periarticular infiltration with a solution containing 200 mg of ropivacaine hydrochloride ,150 mg if the patient weight was below 65kg, 5 mg of morphine hydrochloride , 30 mg of ketorolac tromethamine, 300 micrograms of adrenaline and saline 0.9% till reaching 50 ml of volume. Half of the solution was injected into the proximal hamstring stump. The surgical team closed the wounds and injected the other half of the intervention into the subcutaneous tissue in the distal wound and portals. There was not any medication introduced inside the articulation. Patients of the placebo group were treated in the same way, but the solution injected was 50 ml of saline 0.9%.

DRUG

placebo

50 ml of 0.9 saline

Sponsors & Collaborators

  • Castilla-La Mancha Health Service

    lead OTHER

Principal Investigators

  • Joaquin De Lamo-Rovira, MD · Virgen de La Luz Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2020-09-01
Completion
2020-10-01

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05248724 on ClinicalTrials.gov