Periarticular Injection and Hamstring Block Versus Placebo for Pain Control in Anterior Cruciate Ligament Reconstruction
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Interventional

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

Detailed description: 
      This study was a prospective, two arms, parallel-group, randomized controlled trial conducted
      in a single second-level hospital in Spain. The ethics committee of the institution approved
      the study. Every patient received complete information and signed written consent. A total of
      44 patients were randomized in two groups assigned to receive PI or placebo. The
      perioperative protocol was the same for both groups. The principal outcome was pain measured
      at 8 and 24 hours by a visual analog scale (VAS). The pain was registered in the knee and the
      proximal donor site. Pain scores were also assessed to determine whether the VAS improvement
      would reach the threshold values reported for the minimal clinically significant difference.
      The secondary outcome was the need for opioid rescue medication.

      The surgical procedure was a single bundle transtibial mono tunnel technique with autologous
      hamstring under limb ischemia.

      Patients allocated to the intervention group received a periarticular infiltration with a
      solution containing 200 mg of ropivacaine hydrochloride (10mg/ml Kabi Fresenius Kabi Norway
      AS),150 mg if the patient weight was below 65kg, 5 mg of morphine hydrochloride (10mg/ml
      Braun Medical SA Spain), 30 mg of ketorolac tromethamine (Normon Spain), 300 micrograms of
      adrenaline (epinephrine Braun Medical SA Spain), and saline 0.9% till reaching 50 ml of
      volume. The surgical operation nurse prepared the mixture under sterile conditions at the end
      of the procedure. The 50 ml syringe was connected to a female probe. The surgeon introduced
      the female probe inside the closed tendon stripper to use it as a guide. The tendon stripper
      and female probe were inserted through the distal wound to the proximal stump of the
      hamstring muscles. Half of the solution was injected into this area. The assistant extended
      the knee, and the sartorius fascia was sutured to minimize the leaking of the mixture. 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%.

      The primary outcome was pain registered in the knee and the posterior proximal thigh at 8 and
      24 hours from the surgery. The pain was rated using a 100 mm horizontal line, for which 0
      represented no pain and 100 maximum pain. In addition to statistical significance,
      differences in patient-reported outcomes should be assessed for clinical importance or
      relevance. The secondary outcome was the need for analgesic rescue medication in the
      post-anesthesia care unit and during the stay in the orthopedics ward. Complications
      throughout the hospitalization and in the first month were also registered.

      All statistical analyses were performed using IBM SPSS 25.0 Statistics software, and the
      level of significance was set at α < 0.05. Data are presented as mean (standard deviation-SD)
      for continuous variables and as counts and percentages for categorical variables.
      Characteristics of participants were compared IP group vs. control group using the Chi-square
      test for categorical variables and Student's t-test for continuous variables.
    

Intervention name(s): 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); placebo
Intervention type(s): Combination Product; Drug
Intervention description(s): 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%.; 50 ml of 0.9 saline
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Epinephrine; Racepinephrine; Morphine; Ropivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was a prospective single-blind, two arms, parallel-group
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: postoperative analgesia; Local Anesthetic; postoperative pain