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

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05248724
• Other study ID #: 2017/PI0217
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2022
• Source: Castilla-La Mancha Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

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

Locations

Country	Name	City	State
Spain	Virgen de la Luz Hospital	Cuenca

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

Faunø P, Lund B, Christiansen SE, Gjøderum 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	analgesic rescue medication	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