NCT04343937

Brief Summary

This retrospective study included 30 patients scheduled for lumbar herniectomy under general anesthesia. The patients were randomized to receive either retrolaminar block or intravenous analgesia treatment.Numeric Pain Rating Scale (NPRS) was used to measure the pain intensity of patients in postoperative period. Postoperative analgesic requirements were recorded to asses effectiveness of regional anesthesia.Opiod and NSAİD as rescue medication were recorded postoperatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

April 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

April 8, 2020

Last Update Submit

September 17, 2020

Conditions

Keywords

Retrolaminar block

Outcome Measures

Primary Outcomes (5)

  • postoperative pain: Numeric Pain Rating Scale

    Pain intensity of patients with the Numeric Pain Rating Scale after surgery. The Numerical Pain Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. Zero means the lowest score and no pain.Ten means the highest score and worst pain experienced.

    at the second hour after the surgery

  • postoperative pain: Numeric Pain Rating Scale

    pain intensity of patients with the Numeric Pain Rating Scale after surgery. Pain intensity of patients with the Numeric Pain Rating Scale after surgery. The Numerical Pain Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. Zero means the lowest score and no pain.Ten means the highest score and worst pain experienced.

    at the eighth hour after the surgery

  • postoperative pain: Numeric Pain Rating Scale

    pain intensity of patients with the Numeric Pain Rating Scale after surgery. Pain intensity of patients with the Numeric Pain Rating Scale after surgery. The Numerical Pain Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. Zero means the lowest score and no pain.Ten means the highest score and worst pain experienced.

    at the twelfth hour after the surgery

  • postoperative pain: Numeric Pain Rating Scale

    pain intensity of patients with the Numeric Pain Rating Scale after surgery. Pain intensity of patients with the Numeric Pain Rating Scale after surgery. The Numerical Pain Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. Zero means the lowest score and no pain.Ten means the highest score and worst pain experienced.

    at the twenty forth hour after the surgery

  • postoperative pain: Numeric Pain Rating Scale

    pain intensity of patients with the Numeric Pain Rating Scale after surgery. Pain intensity of patients with the Numeric Pain Rating Scale after surgery. The Numerical Pain Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. Zero means the lowest score and no pain.Ten means the highest score and worst pain experienced.

    at the forty-eighth hour after the surgery

Secondary Outcomes (5)

  • postoperative analgesic requirements

    at the second hour after the surgery

  • postoperative analgesic requirements

    at the eighth hour after the surgery

  • postoperative analgesic requirements

    at the twelfth hour after the surgery

  • postoperative analgesic requirements

    at the twenty forth hour after the surgery

  • postoperative analgesic requirements

    at the forty-eighth hour after the surgery

Study Arms (2)

Retrolaminar block

Retrolaminar block for postoperative pain managment in patients undergoing lumbar herniectomy under general anesthesia

Procedure: retrolaminar block

İntravenous analgesia

İntravenous analgesia for postoperative pain managment in patients undergoing lumbar herniectomy under general anesthesia

Interventions

local anesthetic injection on the between the lamina of the vertebra and the paraspinous muscle

Retrolaminar block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients underwent retrolaminar block

You may qualify if:

  • patients accepted to part in the study

You may not qualify if:

  • patients not accepted to part in the study
  • allergic reaction to local anesthetics drugs
  • lumbar herniectomy of more than two levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nurcan Kutluer Karaca

Erzincan, Turkey (Türkiye)

Location

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
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 14, 2020

Study Start

April 15, 2020

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations