Investigation of the Effects of Two Different Anaesthesia Methods Applied to Patients Scheduled for Arthroscopic Knee Surgery on the Heart

NCT07423754 | Active Not Recruiting

• 1 other identifier: HRÜ/25.03.56
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study will include 80 patients aged 18-65 years who will undergo elective arthroscopic meniscal surgery. Patients with bleeding disorders, cardiac disease, liver and/or renal failure, arrhythmia and electrolyte imbalance, cerebrovascular disease, and those who do not wish to participate in the study will be excluded. Patients will be randomly assigned to two groups of 40 using a sealed envelope method; Group 1 (spinal anaesthesia administered), Group 2 (lumbar/sciatic block administered). After obtaining informed consent from the patients, they will be taken to the operating theatre and a venous access will be established with an 18 G peripheral venous cannula. Once on the operating table, patients will be monitored and an ECG will be performed, and blood will be drawn to measure WBC, lymphocyte, neutrophil, urea, creatinine, and CRP values. Group 1 patients will receive 2 mg midazolam, 50 mcg fentanyl and spinal anaesthesia. Group 2 patients will receive 2 mg midazolam, 50 mcg fentanyl and lumbar/sciatic block. An ECG will be performed on both groups 5 minutes after anaesthesia. Intraoperative heart rate, saturation, and blood pressure monitoring will be performed for both groups. An ECG will be performed on all patients at the end of the case. At the 6th postoperative hour, an ECG will be performed on both groups, blood samples will be taken for WBC, lymphocyte, neutrophil, urea, creatinine, and CRP values, and the first analgesia duration will be recorded.The results obtained will be statistically evaluated, and the study will be concluded. Recruiting.

Conditions

Knee Arthroscopy; Spinal Anaesthesia; Lumbar/Sciatic Block

Keywords

Spinal Anaesthesia; Knee Arthroscopy; Lumbar/Sciatic Block; Frontal QRS-T angle (f[QRS-T]

Outcome Measures

Primary Outcomes (1)

• In our study, we aimed to compare the effects of lumbar/sciatic block and spinal anaesthesia on the QRS-T interval in the electrocardiogram in patients undergoing arthroscopic knee meniscectomy.

  From enrollment to the end of treatment at 10 weeks

Study Arms (2)

Group 1: 40 patients undergoing knee arthroscopy with spinal anaesthesia

ACTIVE COMPARATOR

Group 1: 40 patients undergoing knee arthroscopy with spinal anaesthesia

Procedure: Knee Arthroscopy, Spinal Anaesthesia, Peripheral Nerve Block

Group 2: 40 patients undergoing knee arthroscopy with lumbar/sciatic block

EXPERIMENTAL

Group 2: 40 patients undergoing knee arthroscopy with lumbar/sciatic block

Procedure: Arthroscopic Knee Surgery

Interventions

Knee Arthroscopy, Spinal Anaesthesia, Peripheral Nerve Block PROCEDURE

After obtaining informed consent, patients are taken to the operating room, and venous access will be established with an 18-gauge peripheral venous cannula. Routine ASA monitoring (ECG, noninvasive arterial blood pressure, pulse oximetry) will be performed on patients undergoing surgery. Group 1 patients will receive spinal anesthesia following the administration of 2 mg midazolam and 50 mcg fentanyl. A spinal block will be performed with 15 mg of 0.5% bupivacaine (Marcain® spinal heavy, 0.5%, 4 mL ampoule, AstraZeneca) administered through a 26-gauge spinal needle at the L3-4 intervertebral space, with the patient in a sitting position. Sensory blockade will be assessed with a pinprick test, and surgery will begin once sensory blockade is achieved at the T10 level.

Group 1: 40 patients undergoing knee arthroscopy with spinal anaesthesia

Arthroscopic Knee Surgery PROCEDURE

After obtaining informed consent, patients will be taken to the operating room, and venous access will be established with an 18-gauge peripheral venous cannula. Routine ASA monitoring (ECG, noninvasive arterial blood pressure, pulse oximetry) will be performed on patients undergoing surgery.Group 2 patients will receive 2 mg midazolam and 50 mcg fentanyl, followed by an ultrasound-guided lumbar/sciatic block. A combined sciatic-lumbar nerve block will be administered with a total of 40 cc of 0.5% bupivacaine. The sciatic block will begin with the patient. Patients will be placed in the lateral decubitus 8 position, with the leg to be blocked elevated. Following a negative aspiration, 20 cc of 0.5% bupivacaine will be injected using a 10-cm regional nerve block needle (B Braun, Melsungen, Germany) guided by ultrasound. In the same position, the entry point for the lumbar block will be determined under ultrasound guidance, and following a negative aspiration test, 20 cc of 0.5% bupivaca

Group 2: 40 patients undergoing knee arthroscopy with lumbar/sciatic block

Eligibility Criteria

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

You may qualify if:

• years patient
• ASA I-II status

You may not qualify if:

• Patients under the age of 18, over the age of 65
• Those for whom regional anaesthesia is contraindicated
• Those with known cardiac disease
• Arrhythmia
• Electrolyte imbalance,
• Liver and/or kidney failure.
• Those who do not wish to participate in the study.

Sponsors & Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital: lead

Study Sites (1)

Şanliurfa Mehmet Akif İnan Education and Research Hospital

Sanliurfa, Şanlıurfa, 63000, Turkey (Türkiye)

Location

Related Links

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MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study was designed as a randomised controlled double-blind trial. Eighty patients aged 18-65 years with ASA I-II status, scheduled for arthroscopic knee surgery, will be randomly assigned to two groups of 40 patients each using a sealed envelope method. Group 1 (n=40) will receive spinal anaesthesia, and Group 2 (n=40) will receive a lumbar/sciatic block.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 20, 2026
• Study Start: September 1, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)