Gonyautoxins 2/3 Local Periarticular Injection for Pain Management after Total Knee Arthroplasty: A Double-Blind, Randomized Study

Abstract

The purpose of this study was to compare the efficacy of periarticular infiltration of gonyautoxin 2/3 (GTX 2/3) and a mixture of levobupivacaine, ketorolac, and epinephrine for pain management after total knee arthroplasty (TKA). Forty-eight patients were randomly allocated to receive periarticular infiltration of 40 µg GTX 2/3 (n = 24) diluted in 30 mL of sodium chloride 0.9% (study group) or a combination of 300 mg of levobupivacaine, 1 mg of epinephrine, and 60 mg ketorolac (n = 24) diluted in 150 mL of sodium chloride 0.9% (control group). Intraoperative anesthetic and surgical techniques were identical for both groups. Postoperatively, all patients received patient-controlled analgesia (morphine bolus of 1 mg; lockout interval of 8 minutes), acetaminophen, and ketoprofen for 72 hours. A blinded investigator recorded morphine consumption, which was the primary outcome. Also, the range of motion (ROM) and static and dynamic pain were assessed at 6, 12, 36, and 60 hours after surgery. The incidence of adverse events, time to readiness for discharge, and length of hospital stay were also recorded. The median of total cumulative morphine consumption was 16 mg (range, 0–62 mg) in the GTX 2/3 group and 9 mg (range, 0–54 mg) in control group, which did not reach statistical difference (median test, p = 0.40). Furthermore, static and dynamic pain scores were similar at all time intervals. GTX 2/3 was inferior in range of motion at 6 and 12 hours; nevertheless, we noted no difference after 36 hours. No differences between groups were found in terms of complications, side effects, or length of hospital stay. No significant differences were found between groups in terms of breakthrough morphine requirement. However, local anesthetic use resulted in an increased ROM in the first 12 hours. This prospective randomized clinical trial shows that GTX 2/3 is a safe and efficient drug for pain control after TKA; nevertheless, more studies using GTX 2/3 with larger populations are needed to confirm the safety profile and efficiency. This is level 1 therapeutic study, randomized, double-blind clinical trial.

Keywords

knee arthroplasty - periprosthetic infiltration - gonyautoxin - paralytic shell toxin - pain control

Note

The datasets used or analyzed during the current study are available from the corresponding author on reasonable request

Authors' Contributions

J.H.C contributed the original idea, conceived the study, was senior surgeon, and performed a critical review of the final paper. M.B. supervised the study, performed surgery, performed the statistical analysis, and drafted the manuscript. J.A. was senior anesthesiologist, designed, and supervised the anesthetic protocol. C.B. was senior surgeon, conceived the study, and performed a critical review of the manuscript. A.Z. performed surgery, presented the investigation to the ethical committee. MP recollected data, performed surgery, and drafted the manuscript. J.C. recollected data and drafted the manuscript. M.C. was laboratory coordinator, administered the drug, and executed a critical review of the document. N.L. was gonyautoxin developer and performed a final essential analysis to the manuscript.

Ethical Approval

This study was approved by Hospital Clínico Universidad de Chile Ethics Research Board.

Publication History

Received: 17 November 2020

Accepted: 22 July 2021

Article published online:
10 September 2021

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