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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04343937
Other study ID # Erzincan Binali Y. University
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date June 15, 2020

Study information

Verified date September 2020
Source Erzincan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This retrospective study included 30 patients scheduled for lumbar herniectomy under general anesthesia. The patients were randomized to receive either RLB or intravenous analgesia treatment. All patients were routinely monitored and their heart rate, blood pressure and pulse oxymetry recorded during the anesthesia. Numeric Pain Rating Scale (NPRS) scores evaluated at 2, 8, 12, 24 and 48 h after the surgery. Opiod and NSAİD as rescue medication were recorded postoperatively


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 15, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- patients accepted to part in the study

Exclusion Criteria:

- patients not accepted to part in the study

- allergic reaction to local anesthetics drugs

- lumbar herniectomy of more than two levels

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
retrolaminar block
local anesthetic injection on the between the lamina of the vertebra and the paraspinous muscle

Locations

Country Name City State
Turkey Nurcan Kutluer Karaca Erzincan

Sponsors (1)

Lead Sponsor Collaborator
Erzincan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 postoperative analgesic requirements Opiod and Nonsteroidal Anti-inflammatory Drugs as rescue medication recorded postoperatively. at the second hour after the surgery
Secondary postoperative analgesic requirements Opiod and Nonsteroidal Anti-inflammatory Drugs as rescue medication recorded postoperatively. at the eighth hour after the surgery
Secondary postoperative analgesic requirements Opiod and Nonsteroidal Anti-inflammatory Drugs as rescue medication recorded postoperatively. at the twelfth hour after the surgery
Secondary postoperative analgesic requirements Opiod and Nonsteroidal Anti-inflammatory Drugs as rescue medication recorded postoperatively. at the twenty forth hour after the surgery
Secondary postoperative analgesic requirements Opiod and Nonsteroidal Anti-inflammatory Drugs as rescue medication recorded postoperatively. at the forty-eighth hour after the surgery
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