Effect of LIA on Postoperative Pain Following ACL Reconstruction

Pain, Postoperative Clinical Trial

Official title:

Effect of Local Infiltration Analgesia on Postoperative Pain Following Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03873077
• Other study ID #: MMS.2019.001
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 2020

Study information

• Verified date: March 2019
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: Alain F Kalmar, MD, PhD, MSc
• Phone: +32 246 17 29
• Email: alainkalmar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

2 x 20 patients which are planned for arthroscopic ACL reconstruction are randomised:

standard-group and LIA-group.

All patients receive standardised multimodal intravenous analgesia. After standardised induction of anesthesia, patient positioning and administration of basic analgetics (paracetamol, diclofenac, clonidine and morfine), patients in the LIA-group receive a local infiltration in the knee of 10 mL ropivacaine and 10 mL lidocaine.

Visual Analogue Scores are assessed 15 minutes after awakening from surgery and on Day 1, 2, 3, 7, 14, 21 and 28 after surgery. Postoperative analgesic consumption are registered in the first month after the surgery. The quality of recovery after anesthesia is assessed on Day 1 by the postoperative quality of recovery score (QoR-15).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• elective arthroscopic anterior cruciate ligament reconstruction

• adult

Exclusion Criteria:

• unwilling or unable to grant written informed consent

• revisions

• contra-indication for ropivacaine

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Pain, Postoperative
• Rupture

Intervention

Procedure:
• local infiltration analgesia
10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL

Locations

Country	Name	City	State
Belgium	General Hospital Maria Middelares	Ghent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View Citation

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. — 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative analgesia consumption	Dosing and frequency of analgesia consumption	From moment of surgery until one month after surgery
Secondary	General patient comfort	Quality of recovery score (QoR-15) on the first day after surgery	From moment of surgery until one day after surgery
Secondary	Incidence of nausea and vomiting	Incidence of postoperative nausea and vomiting	From moment of surgery until hospital discharge (one day after surgery)
Secondary	PONV treatment	Number of pharmacological treatments for postoperative nausea and vomiting (PONV)	From moment of surgery until hospital discharge (one day after surgery)