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

NCT ID: NCT04711668

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-29
• Study Completion Date: 2020-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group Ketamin

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

intraoperative ketamine bolus and infusion

Group Lidokain

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

Group Type: EXPERIMENTAL

Lidocain

Intervention Type: DRUG

intraoperative lidocain bolus and infusion

Group Placebo

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

intraoperative saline bolus and infusion

Interventions

Ketamine

intraoperative ketamine bolus and infusion

Intervention Type: DRUG

Lidocain

intraoperative lidocain bolus and infusion

Intervention Type: DRUG

Saline

intraoperative saline bolus and infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Vedat Öztürk

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Atatürk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B.30.2.ATA.0.01.00/308

Identifier Type: -

Identifier Source: org_study_id