Effects of Erector Spinae Plane Block and Intrathecal Morphine Administration on Intraoperative Sevoflurane Consumption

November 16, 2024 updated by: Yusuf Özgüner, Ankara Etlik City Hospital

Comparison of the Effects of Erector Spinae Plane Block and Intrathecal Morphine Administration on Intraoperative Sevoflurane Consumption in Disc Surgeries

In our study, the investigators aimed to compare the intraoperative sevoflurane consumption and postoperative analgesic needs of patients who underwent lumbar disc herniation surgery and received either ESP block or ITM in the preoperative period with a control group.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The amount of volatile anesthetic agents used for anesthesia maintenance can be significantly reduced with potent and long-acting analgesic interventions administered during the preoperative period. Such interventions enable the maintenance of anesthesia with more optimal levels of agents during surgery, providing significant advantages in terms of both patient safety and cost.

Studies have recommended multimodal analgesia approaches involving the Erector Spinae Plane (ESP) block and intrathecal morphine (ITM) injection for various surgical procedures. These two methods, through different mechanisms of action, not only reduce intraoperative anesthetic agent consumption but also play a critical role in postoperative pain management. Although studies have investigated the effects of ESP block and ITM injection on intraoperative volatile anesthetic consumption, there is limited research directly comparing their impacts on volatile anesthetic consumption and postoperative analgesic requirements.

In our study, we aimed to compare the intraoperative sevoflurane consumption and postoperative analgesic needs of patients who underwent lumbar disc herniation surgery and received either ESP block or ITM in the preoperative period with a control group.

Study Type

Observational

Enrollment (Estimated)

99

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
    • Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
      • Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey, 06170
        • Ankara Etlik City 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

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients operated for single level and non-recurring lumbar disc herniation.

Description

Inclusion Criteria:

  • Patients aged over 18 years
  • Patients receiving general anesthesia
  • Patients with an ASA score of I-II
  • Patients undergoing elective surgery for single-level lumbar disc herniation
  • Patients who provided informed consent after being informed

Exclusion Criteria:

Patients who did not provide informed consent after being informed

  • Patients over 65 years of age
  • Patients with an ASA score of III or higher
  • Patients with recurrent lumbar disc herniation (LDH)
  • Patients undergoing surgery for multi-level LDH
  • Patients with a body mass index (BMI) of 30 or higher
  • Patients with allergies to morphine or bupivacaine
  • Patients with major cardiac, respiratory, hepatic, renal, neurological, or psychiatric diseases
  • Patients with a history of alcohol or substance abuse
  • Patients with a local infection at the injection site
  • Patients with bleeding diathesis
  • Patients with a history of anticoagulant medication use
  • Patients with contraindications to spinal or regional anesthesia

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ESP
ESP block was applied to patients in this group in the preoperative period.
Other: ESP block
ESP block was applied to the patients.
ITM
Intrathecal morphine was applied to patients in this group in the preoperative period.
Other: ITM
ITM was applied to the patients.
Control
Patients who did not undergo ESP block or ITM were included in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Sevoflurane consumption
Time Frame: 60 minutes after anesthesia induction
End-expiratory sevoflurane concentration was monitored every 5 minutes for 60 minutes. The mean sevoflurane concentration in the first 60 minutes was calculated.
60 minutes after anesthesia induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescue analgesic consumption
Time Frame: 2 hours postoperatively
When numerical rating scale was 4 or above, rescue analgesic was administered to the patient.
2 hours postoperatively
Rescue analgesic consumption
Time Frame: 4 hours postoperatively
When numerical rating scale was 4 or above, rescue analgesic was administered to the patient.
4 hours postoperatively
Rescue analgesic consumption
Time Frame: 8 hours postoperatively
When numerical rating scale was 4 or above, rescue analgesic was administered to the patient.
8 hours postoperatively
Rescue analgesic consumption
Time Frame: 12 hours postoperatively
When numerical rating scale was 4 or above, rescue analgesic was administered to the patient.
12 hours postoperatively
Rescue analgesic consumption
Time Frame: 24 hours postoperatively
When numerical rating scale was 4 or above, rescue analgesic was administered to the patient.
24 hours postoperatively

Collaborators and Investigators

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

Sponsor

Ankara Etlik City 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.

General Publications

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 (Estimated)

November 20, 2024

Primary Completion (Estimated)

January 10, 2025

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 16, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bengü Tez

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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