CClinicalTrials.gg
CompletedNCT06777953Updated Jan 16, 2025

Regional Anesthesia for Lower Extremity Surgery

An observational study in Erector Spinae Plane Block, Lower Extremity Surgery and Sciatic Nerve Block, sponsored by Haseki Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-16.

Sponsored by Haseki Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
32
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Erector Spinae Plane Block
  • Lower Extremity Surgery
  • Sciatic Nerve Block

Keywords

  • sacral erector spinae plane block
  • lower extremity surgery
  • lumbar erector spinae plane block
  • sciatic nerve block
03

In context

Lead sponsor

Haseki Training and Research Hospital is the lead sponsor of 75 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
32 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherErector Spinae (ESP) Block with Lidocaine/Bupivacaine

    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.

  • OtherPopliteal Sciatic Nerve Block

    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.

06

What researchers measure

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.

    Time frame: 24 hours

Secondary outcomes

  1. Block related complication

    Patients will be evaluated with Bromage Scale and mobilization times.The bromage scale is a numerical assessment ranging from 0 to 3. A score of 0 is No motor block, a score of 1 is Inability to raise extended leg; able to move knees and feet no pain, a score of 2 is Inability to raise extended leg and move knee; able to move feet, a score of 3 is Complete block of motor limb.It will also be checked when the patients can walk after the motor block has passed.

    Time frame: 24 hours

07

Study locations

1 site
  • Haseki Training and Research Hospital
    Istanbul, 34265, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06777953
Lead sponsor
Haseki Training and Research Hospital
Responsible party
Sponsor
First posted
Jan 16, 2025
Start date
Nov 1, 2024
Primary completion
Dec 15, 2024
Completion
Dec 28, 2024
Last update
Jan 16, 2025

Study contacts

Munevver Kayhan, Medical Doctor
principal investigator · Haseki Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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