Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery

NCT04711668 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/308
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The primary aim of this study was to investigate the effect of ketamine and lidocaine on postoperative opioid consumption in posterior spinal fusion surgery. Materials and Methods: Ethics committee approval was received from our faculty. Seventy-five cases between the ages of 18-65, who have an ASA (American Society of Anesthesiologists) risk classification I-II-III in the preanesthetic evaluation, planned to be operated by the Neurosurgery clinic for lumbar posterior spinal fusion surgery under elective conditions have been included in the study after the informed volunteer consent form was read and approved. The patients were randomly divided into 3 groups using the closed envelope method. The ketamine group (Group K) (n = 25), the lidocaine group (Group L) (n = 25) and the placebo group (Group P) (n = 25). Propofol, rocuronium and fentanyl i.v. done. In group K, 0.5 mg / kg i.v. ketamine bolus and 0.25 mg / kg / hr i.v. ketamine infusion was administered. In group L, 1.5 mg / kg i.v. lidocaine bolus and 1.5 mg / kg / hr i.v. lidocaine infusion was administered. In group P, i.v. saline (in the same volume and duration) was applied. Maintenance of anesthesia was provided by propofol and remifentanil infusion. The propofol and remifentanil doses were adjusted according to the BIS monitoring and the increase or decrease in basal blood pressure and heart rate values of 20% or more. The BIS value was kept between 40-60. At the end of surgery, infusions were closed. After extubation, the patients were taken to the recovery room. Patient controlled analgesia (PCA) prepared with fentanyl was applied to the patients for postoperative analgesia. The PCA device was attached for 24 hours postoperatively. Postoperative 0-4 hours, 4-8 hours, 8-24 hours and total fentanyl consumption of the patients were evaluated. Pain scores were measured at 1, 2, 4, 8, 12 and 24 hours in the postoperative recovery room. Intraoperative propofol and remifentanil consumption was recorded. Tramadol 1 mg / kg i.v. as rescue analgesia (in patients with VAS pain score of 4 and above) done. Possible side effects due to opioid, ketamine and lidocaine were followed.

Conditions

Spine Fusion; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• postoperative opioid consumption

  postoperative PCA wit fentanyl

  postoperative 0-24 hours

Secondary Outcomes (1)

• postoperative pain score

  postoperative 0-24 hours

Study Arms (3)

Group Ketamin

EXPERIMENTAL

0.5 mg / kg i.v. ketamine bolus at induction and 0.25 mg / kg / hr i.v. ketamine infusion intraoperatively

Drug: Ketamine

Group Lidokain

EXPERIMENTAL

1.5 mg / kg i.v. lidocaine bolus at induction and 1.5 mg / kg / hr i.v. lidocaine infusion intraoperatively

Drug: Lidocain

Group Placebo

PLACEBO COMPARATOR

i.v. saline (in the same volume and duration like group ketamine/lidokain)

Drug: Saline

Interventions

Ketamine DRUG

intraoperative ketamine bolus and infusion

Group Ketamin

Lidocain DRUG

intraoperative lidocain bolus and infusion

Group Lidokain

Saline DRUG

intraoperative saline bolus and infusion

Group Placebo

Eligibility Criteria

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

You may qualify if:

• between the ages of 18-65, who have an ASA (American Society of Anesthesiologists) risk classification I-II-III

You may not qualify if:

• Previous spinal surgery, Morbid obesity (BMI\> 35 kg / m2), Lidocaine, ketamine or opioid allergy. Severe cardiac or pulmonary disease, Liver or kidney dysfunction Poorly controlled hypertension, Substance abuse, Chronic opioid use, Pregnancy, Psychiatric disorder, Cognitive impairment History of stroke, head injury, and intracranial mass or bleeding and patients who did not want to participate in the study were excluded from the study.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University

Erzurum, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: May 29, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

TU (1)