NCT06693141

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

November 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 15, 2024

Last Update Submit

November 16, 2024

Conditions

Postoperative PainAnesthesia

Keywords

Erector Spinae Plane blockIntrathecal morphine

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Sevoflurane consumption

    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 Outcomes (5)

  • Rescue analgesic consumption

    2 hours postoperatively

  • Rescue analgesic consumption

    4 hours postoperatively

  • Rescue analgesic consumption

    8 hours postoperatively

  • Rescue analgesic consumption

    12 hours postoperatively

  • Rescue analgesic consumption

    24 hours postoperatively

Study Arms (3)

ESP

ESP block was applied to patients in this group in the preoperative period.

Other: ESP block

ITM

Intrathecal morphine was applied to patients in this group in the preoperative period.

Other: ITM

Control

Patients who did not undergo ESP block or ITM were included in this group.

Interventions

ESP blockOTHER

ESP block was applied to the patients.

ESP
ITMOTHER

ITM was applied to the patients.

ITM

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (3)

  • Yorukoglu HU, Icli D, Aksu C, Cesur S, Kus A, Gurkan Y. Erector spinae block for postoperative pain management in lumbar disc hernia repair. J Anesth. 2021 Jun;35(3):420-425. doi: 10.1007/s00540-021-02920-0. Epub 2021 Mar 22.

    PMID: 33751203BACKGROUND

  • Lal A, Singh MK, Kanaujia SK, Mishra NK, Singh BP, Singh GP. Comparison of Intrathecal Morphine Versus Erector Spinae Plane Block for Perioperative Analgesia in Patients Undergoing Lumbar Spine Surgery: A Randomized Control Trial. Cureus. 2024 Jul 17;16(7):e64775. doi: 10.7759/cureus.64775. eCollection 2024 Jul.

    PMID: 39156461BACKGROUND

  • Nashibi M, Sezari P, Safari F, Teymourian H, Asgari S, Mottaghi K. The effect of erector spinae plane block on the use of anesthetic medications in lumbar spine surgery. Agri. 2023 Oct;35(4):228-235. doi: 10.14744/agri.2022.48992.

    PMID: 37886866RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2024

First Posted

November 18, 2024

Study Start

November 20, 2024

Primary Completion

January 10, 2025

Study Completion

January 15, 2025

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)