Effect of LIA on Postoperative Pain Following ACL Reconstruction

NCT03873077 | Unknown

• 1 other identifier: MMS.2019.001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

An anterior cruciate ligament (ACL) rupture is one of the most common sport injuries, which typically develops after a sudden knee torsion. Arthroscopic repair of the ACL is often required as a complete ACL tear can cause instability of the knee joint. During arthroscopic reconstruction the lower leg is reattached to the upper leg using part of the hamstring tendon (mm. gracilis and mm. semitendinosus). Optimal postoperative analgesia is necessary to allow a quick recovery. Intravenous analgesia during surgery is often associated with a number of side effects such as nausea, vomiting and muscle weakness and does not anesthetize the donor site of the hamstring tendon graft. Local infiltration of ropivacaine and lidocaine in the knee joint and at the donor site can be a valuable asset to control the postoperative pain. This study evaluates the effect of local infiltration analgesia (LIA) on the postoperative pain in the first month after an ACL reconstruction. Half of participants will only receive intravenous analgesia during surgery, the other half will receive intravenous analgesia and a LIA.

Conditions

Anterior Cruciate Ligament Rupture; Pain, Postoperative

Keywords

local infiltration analgesia; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale for pain

  Pain intensity using the VAS (where 0 = no pain and 100 = pain as bad as can be) 15 minutes after awakening and on Day 1, 2, 3, 7, 14, 21 and 28 after surgery.

  From moment of surgery until one month after surgery

Secondary Outcomes (4)

• Postoperative analgesia consumption

  From moment of surgery until one month after surgery

• General patient comfort

  From moment of surgery until one day after surgery

• Incidence of nausea and vomiting

  From moment of surgery until hospital discharge (one day after surgery)

• PONV treatment

  From moment of surgery until hospital discharge (one day after surgery)

Study Arms (2)

intravenous analgesia

NO INTERVENTION

Patient receives intravenous analgesia: paracetamol 30 mg/kg, diclofenac 75 mg, clonidine 1 µg/kg and morfine 0,05 mg/kg

intravenous analgesia + LIA

OTHER

Patient receives intravenous analgesia and a local infiltration analgesia in the knee

Procedure: local infiltration analgesia

Interventions

local infiltration analgesia PROCEDURE

10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL

intravenous analgesia + LIA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective arthroscopic anterior cruciate ligament reconstruction
• adult

You may not qualify if:

• unwilling or unable to grant written informed consent
• revisions
• contra-indication for ropivacaine

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (1)

General Hospital Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Related Publications (4)

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

  PMID: 23411725 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

• Kerr DR, Kohan L. Local infiltration analgesia: a technique for the control of acute postoperative pain following knee and hip surgery: a case study of 325 patients. Acta Orthop. 2008 Apr;79(2):174-83. doi: 10.1080/17453670710014950.

  PMID: 18484242 BACKGROUND

• Kristensen PK, Pfeiffer-Jensen M, Storm JO, Thillemann TM. Local infiltration analgesia is comparable to femoral nerve block after anterior cruciate ligament reconstruction with hamstring tendon graft: a randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):317-23. doi: 10.1007/s00167-013-2399-x. Epub 2013 Jan 23.

  PMID: 23338666 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Pain, Postoperative

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Alain F Kalmar

  Maria Middelares Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain F Kalmar, MD, PhD, MSc

CONTACT

+32 246 17 29; alainkalmar@gmail.com

Pieter Byn, MD, Msc

CONTACT

pieterbyn@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesist

Model Details: Group A receives standard treatment (intravenous analgesia). Group B received intravenous analgesia and a LIA.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: March 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)