Added Value of Systemic Lidocaine on Postoperative Pain, Opiate Use and Nausea After Knee Arthroscopy

Surgery Clinical Trial

Official title:

Added Value of Systemic Lidocaine in Combination With Local Infiltration Analgesia for Knee Arthroscopic Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599427
• Other study ID #: MMS.2017.032
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: October 2019
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Local intra-articular injection of anesthetics (LIA) is increasingly used during knee arthroscopy for pain relief. The LIA can only be performed at the end of surgery as the knee joint is continuously flushed during the arthroscopy. As a consequence, an optimal analgesic effect is only obtained one hour after surgery and opiates are typically used as pain relief in the immediate postoperative period. Since these opiates have a number of side effects such as nausea, vomiting and drowsiness, other analgetic methods are desirable.

Intravenous administration of lidocaine, a safe, inexpensive analgesic, is already used in major (abdominal) surgeries and might also be a promising method for pain relief in the first hour after knee arthroscopy, in anticipation of the onset of the analgesic effect of the LIA.

The aim of this study is to verify if systemic administration of lidocaine has a beneficial effect on the pain immediately after knee arthroscopy. In addition, the effect of systemic lidocaine administration on postoperative nausea, vomiting and general patient comfort will be evaluated.

Description:

2X30 patients which are planned for elective knee arthroscopy are randomised: Lidocaine-group and Placebo-group.

All patients receive standardised multimodal intravenous analgesia. After standardised induction of anesthesia, patient positioning and administration of basic analgetics paracetamol & diclofenac, the patient is administered either linisol 2% (1.5 mg/kg) or placebo NaCl 0.9% (0.075 ml/kg = equivalent volume). At the end of the procedure, linisol or placebo is readministered at the same dose. The surgeon and anesthesiologist are blinded for patient allocation.

Postoperative analgesic consumption, nausea and vomiting (PONV), general comfort and pain scores are recorded. Visual Analogue scores (VAS) for knee pain are assessed before surgery, 1-15 minutes after awakening, at the moment of discharge from the post-anesthesia care unit (PACU) and at hospital discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• signed informed consent

• patients which are planned for elective knee arthroscopy

• ASA 1 and 2

• knee arthroscopy suitable for intra-articular injection of anesthetics

Exclusion Criteria:

• contra-indication for lidocaine, paracetamol or diclofenac

• known history of severe post-operative nausea or vomiting

• knee arthroscopy associated with anterior cruciate ligament reconstruction

Related Conditions & MeSH terms

• Nausea
• Nausea, Postoperative
• Opioid Use
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Surgery

Intervention

Drug:
• systemic lidocaine
Systemic lidocaine is administrated at induction of anesthesia and at the end of surgery (1.5 mg/kg).
• Placebo
Placebo is administrated at induction of anesthesia and at the end of surgery (0.075 ml/kg)

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Gent	Oost

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Score for pain	Pain intensity using the VAS, where 0 = no pain and 100 = pain as bad as can be) before surgery, 1-15 minutes after awakening, at discharge from the PACU and from the hospital	from moment of surgery until hospital discharge. on average 8 hours after surgery
Secondary	incidence of Nausea and vomiting	Incidence of postoperative nausea and vomiting	from moment of surgery until hospital discharge. on average 8 hours after surgery
Secondary	PONV treatment	Number of pharmacological treatments for Postoperative Nausea & Vomiting (PONV)	from moment of surgery until hospital discharge. on average 8 hours after surgery
Secondary	opioid use	dosing and frequency of opioid use	at the PACU on average 60 minutes
Secondary	length of stay at the PACU	Time (in minutes) between the end of surgery and the discharge from the PACU	from moment of surgery until discharge from the PACU. on average 60 minutes after surgery
Secondary	general patient comfort	VAS for general comfort : from 0 until 100 (0= extremely dissatisfied ; 100= extremely satisfied.	at the moment before of hospital discharge. on average 8 hours after surgery.