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

NCT05248724 | Completed

• 1 other identifier: 2017/PI0217
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

postoperative analgesia; Local Anesthetic; postoperative pain

Outcome Measures

Primary Outcomes (4)

• Pain in the knee at 8 hours after surgery assessed by visual analog scale

  pain registered in the knee, which was measured using a 100-mm visual analog scale from 0 (no pain) to 100 (the worst pain)

  registered at 8 hours

• Pain in the knee at 24 hours after surgery assessed by visual analog scale

  pain registered in the knee, which was measured using a 100-mm visual analog scale from 0 (no pain) to 100 (the worst pain)

  registered at 24 hours

• Pain in the posterior proximal thigh at 8 hours after surgery assessed by visual analog scale

  pain registered in the posterior proximal thigh, which was measured using a 100-mm visual analog scale from 0 (no pain) to 100 (the worst pain)

  registered at 8 hours

• Pain in the posterior proximal thigh at 24 hours after surgery assessed by visual analog scale

  pain registered in the posterior proximal thigh, which was measured using a 100-mm visual analog scale from 0 (no pain) to 100 (the worst pain)

  registered at 24 hours

Secondary Outcomes (1)

• analgesic rescue medication

  24 hours post operative

Study Arms (2)

Intervention,

EXPERIMENTAL

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

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)

placebo

PLACEBO COMPARATOR

Participants in the placebo group received a periarticular infiltration of 50 ml of saline 0.9%.

Drug: placebo

Interventions

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) COMBINATION_PRODUCT

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%.

Intervention,

placebo DRUG

50 ml of 0.9 saline

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anterior cruciate ligament reconstruction

You may not qualify if:

• revision surgery.
• reconstruction with a different graft from hamstring tendons.
• Associated osteotomy.
• Less than 50 kg, and allergy.
• medical contraindication for any of the components of the periarticular infiltration or postoperative analgesic medical protocol.

Sponsors & Collaborators

• Castilla-La Mancha Health Service: lead

Study Sites (1)

Virgen de la Luz Hospital

Cuenca, 16004, Spain

Location

Related Publications (5)

• Kurosaka K, Tsukada S, Nakayama H, Iseki T, Kanto R, Sugama R, Yoshiya S. Periarticular Injection Versus Femoral Nerve Block for Pain Relief After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Arthroscopy. 2018 Jan;34(1):182-188. doi: 10.1016/j.arthro.2017.08.307. Epub 2017 Dec 6.

  PMID: 29203380 BACKGROUND

• Lefevre N, Klouche S, de Pamphilis O, Herman S, Gerometta A, Bohu Y. Peri-articular local infiltration analgesia versus femoral nerve block for postoperative pain control following anterior cruciate ligament reconstruction: Prospective, comparative, non-inferiority study. Orthop Traumatol Surg Res. 2016 Nov;102(7):873-877. doi: 10.1016/j.otsr.2016.07.011. Epub 2016 Oct 4.

  PMID: 27720193 BACKGROUND

• Bushnell BD, Sakryd G, Noonan TJ. Hamstring donor-site block: evaluation of pain control after anterior cruciate ligament reconstruction. Arthroscopy. 2010 Jul;26(7):894-900. doi: 10.1016/j.arthro.2009.11.022. Epub 2010 May 13.

  PMID: 20620788 BACKGROUND

• Jansson H, Narvy SJ, Mehran N. Perioperative Pain Management Strategies for Anterior Cruciate Ligament Reconstruction. JBJS Rev. 2018 Mar;6(3):e3. doi: 10.2106/JBJS.RVW.17.00059. No abstract available.

  PMID: 29533268 BACKGROUND

• Fauno P, Lund B, Christiansen SE, Gjoderum O, Lind M. Analgesic effect of hamstring block after anterior cruciate ligament reconstruction compared with placebo: a prospective randomized trial. Arthroscopy. 2015 Jan;31(1):63-8. doi: 10.1016/j.arthro.2014.07.024. Epub 2014 Sep 17.

  PMID: 25239172 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Ketorolac Tromethamine; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Joaquin De Lamo-Rovira, MD

  Virgen de La Luz Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants were not informed about what group (intervention or placebo) they were assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study was a prospective single-blind, two arms, parallel-group

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: February 21, 2022
• Study Start: August 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)