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

February 17, 2026 updated by: Tuğba Bingöl Tanriverdi, Sanliurfa Mehmet Akif Inan Education and Research Hospital

COMPARISON OF THE EFFECT OF LUMBAR/SCIATIC BLOCK AND SPINAL ANAESTHESIA ON THE FRONTAL QRS-T ANGLE AND INFLAMMATORY VALUES IN ARTHROSCOPIC KNEE SURGERIES

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study was designed as a randomised controlled double-blind trial. Eighty patients aged 18-65 years with ASA I-II status who were scheduled for arthroscopic knee surgery were divided into two groups of 40 patients each using a sealed envelope method. Group 1 (n=40) received spinal anaesthesia, and Group 2 (n=40) received a lumbar/sciatic block. Patients under 18 years of age, over 65 years of age, those for whom regional anaesthesia is contraindicated, those with known cardiac disease, arrhythmia, electrolyte imbalance, liver and/or renal failure, and those who do not wish to participate in the study will be excluded. After obtaining informed consent from the patients, they will be taken to the operating theatre and a venous access will be established using an 18 G peripheral venous cannula. Patients undergoing surgery will undergo routine ASA monitoring (ECG, non-invasive arterial blood pressure, pulse oximetry). Group 1 patients will receive 2 mg midazolam and 50 mcg fentanyl, followed by spinal anaesthesia. The patient will be placed in a sitting position, and a spinal block will be administered by injecting 15 mg of 0.5% bupivacaine (Marcain® spinal heavy, 0.5%, 4 mL ampoule, AstraZeneca) through a 26 G spinal needle into the L3-4 intervertebral space. Sensory block will be assessed with a pinprick test, and the operation will commence once sensory block at the T10 level is achieved. Group 2 patients will receive 2 mg midazolam and 50 mcg fentanyl, and a lumbar/sciatic block will be performed under ultrasound guidance.A combined sciatic-lumbar nerve block with a total of 40 cc of 0.5% bupivacaine will be administered. The sciatic block will be performed first. For this, patients will be placed in the lateral decubitus 8 position, with the leg to be blocked on top, in the 'Sim's' position. Under ultrasound guidance, 20 cc of 0.5% bupivacaine will be injected with a 10 cm regional nerve block needle (B Braun, Melsungen, Germany) following negative aspiration. In the same position, the entry point for the lumbar block will be determined under ultrasound guidance, and 20 cc of 0.5% bupivacaine will be administered following a negative aspiration test. For surgical anaesthesia, both the sciatic and lumbar nerve distribution areas will be tested with the pinprick test to assess complete sensory block and complete motor block in the knee, ankle, and toes. Patients with adequate block quality (no need for sedoanalgesia during the operation) will be included in the study. In both groups, heart rate and mean arterial pressure will be recorded preoperatively (T1), after anaesthesia administration (T2), during surgery at 5 (T3), 15 (T4), and 30 (T5) minutes, and postoperatively (T6). ECG recordings will be obtained preoperatively, 5 minutes after anaesthesia administration, at the end of surgery, and 6 hours postoperatively. The duration of the first postoperative analgesia will be recorded for all patients. Haemogram and biochemical parameters will be assessed preoperatively, at the end of surgery, and 6 hours postoperatively.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Şanlıurfa
      • Sanliurfa, Şanlıurfa, Turkey (Türkiye), 63000
        • Sanliurfa Mehmet Akif Inan Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-65 years patient
  • ASA I-II status

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: 40 patients undergoing knee arthroscopy with spinal anaesthesia
Procedure: Knee Arthroscopy, Spinal Anaesthesia, Peripheral Nerve Block
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.
Experimental: Group 2: 40 patients undergoing knee arthroscopy with lumbar/sciatic block
Procedure: Arthroscopic Knee Surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: From enrollment to the end of treatment at 10 weeks
From enrollment to the end of treatment at 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRÜ/25.03.56

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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