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

February 21, 2022 updated by: Castilla-La Mancha Health Service

Periarticular Injection and Hamstring Block Versus Placebo for Pain Control in Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cuenca, Spain, 16004
        • Virgen de la Luz Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Anterior cruciate ligament reconstruction

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention,
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)
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%.
Placebo Comparator: placebo
Participants in the placebo group received a periarticular infiltration of 50 ml of saline 0.9%.
Drug: placebo
50 ml of 0.9 saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain in the knee at 8 hours after surgery assessed by visual analog scale
Time Frame: registered at 8 hours
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
Time Frame: registered at 24 hours
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
Time Frame: registered at 8 hours
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
Time Frame: registered at 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesic rescue medication
Time Frame: 24 hours post operative
Number of patients who needed analgesic rescue medication in the post-anesthesia care unit and during the stay in the orthopedics ward
24 hours post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castilla-La Mancha Health Service

Investigators

  • Principal Investigator: Joaquin De Lamo-Rovira, MD, Virgen de la Luz Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

February 6, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/PI0217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anterior Cruciate Ligament Reconstruction

Clinical Trials on 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)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe