NCT06777953

Brief Summary

In this study, patients who underwent osteosynthesis with plate via standard anterolateral incision due to proximal tibia fracture in the orthopedic clinic within the last year; those who underwent perioperative anesthesia with spinal block, those who underwent postoperative analgesia with Ultrasound-guided popliteal sciatic nerve block, lumbar-sacral Erector Spine plane block combinations in the recovery unit will be identified and their files will be scanned retrospectively. Gender, surgical duration, postoperative block, pre-post block pain levels will be reviewed via Visual Analog Scale scoring, postoperative analgesics consumed and their amounts, Bromage scale, mobilization times, block-related complications, satisfaction levels will be determined and these two groups of patients who underwent block will be compared in terms of analgesia, complications, and satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

January 4, 2025

Last Update Submit

January 10, 2025

Conditions

Keywords

sacral erector spinae plane blocklower extremity surgerylumbar erector spinae plane blocksciatic nerve block

Outcome Measures

Primary Outcomes (1)

  • Postoperative Analgesia

    Postoperative analgesia will be assessed by Visual Analog Scale Score and postoperative analgesic consumption. The visual analog scale is a numerical assessment ranging from 0 to 10. A score of 0 is considered as no pain, a score of 5 is considered as moderate pain, and a score of 10 is considered as unbearable pain. Rescue intravenous analgesic treatment is applied to scores of 4 and above.

    24 hours

Secondary Outcomes (1)

  • Block related complication

    24 hours

Study Arms (2)

Erector Spinae Plane Block Group

Patients who underwent spinal anesthesia due to tibial fracture will be identified from their follow-up files. Among these patients, those who underwent erector spinae plane block with 20 ml of 0.5% bupivacaine and 5 ml of 1% lidocaine at the sacral level and 20 ml of 0.5% bupivacaine and 5 ml of 1% lidocaine at the L3 level while sitting under ultrasound guidance for postoperative analgesia will constitute this group.

Other: Erector Spinae (ESP) Block with Lidocaine/Bupivacaine

Sciatic Nerve Plane Block Group

Patients who underwent spinal anesthesia due to tibial fracture will be identified from their follow-up files. Among these patients, those who underwent popliteal sciatic nerve block with 30 ml of 0.5% bupivacaine while supine position under ultrasound guidance for postoperative analgesia will constitute this group.

Other: Popliteal Sciatic Nerve Block

Interventions

This study is to retrospectively compare the analgesic efficacy and impact on postoperative recovery of popliteal sciatic nerve blocks and Lumbar-Sacral Erector Spinae Plane blocks administered for postoperative pain management in tibial fractures.

Erector Spinae Plane Block Group

This study is to retrospectively compare the analgesic efficacy and impact on postoperative recovery of popliteal sciatic nerve blocks and Lumbar-Sacral Erector Spinae Plane blocks administered for postoperative pain management in tibial fractures.

Sciatic Nerve Plane Block Group

Eligibility Criteria

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

Patients with proximal tibial fractures who underwent surgery within the past year at the orthopedic clinic.

You may qualify if:

  • Patients aged 18-65
  • Patients undergoing spinal anesthesia
  • Patients undergoing postoperative erector spinae plane block
  • Patients undergoing postoperative sciatic nerve block

You may not qualify if:

  • Pregnant patients
  • Patients who cannot be contacted
  • Patients who have undergone perioperative general anesthesia
  • Patients with a history of cerebrovascular disease
  • Patients with data loss
  • Patients who did not receive consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, 34265, Turkey (Türkiye)

Location

MeSH Terms

Interventions

ParapsychologyDental OcclusionLidocaineBupivacaine

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and ActivitiesDentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Munevver Kayhan, Medical Doctor

    Haseki Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2025

First Posted

January 16, 2025

Study Start

November 1, 2024

Primary Completion

December 15, 2024

Study Completion

December 28, 2024

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations