Postoperative PainNCT04343937
Retrolaminar Block for Postoperative Analgesia in Lumbar Herniectomy Surgery
An observational study of Postoperative Pain, run by Erzincan University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- retrolaminar block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2020to 15 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients underwent retrolaminar block
Who may be able to join
- patients accepted to part in the study
Who cannot join
- patients not accepted to part in the study
- allergic reaction to local anesthetics drugs
- lumbar herniectomy of more than two levels
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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
- Conditions
- Postoperative Pain
- Being tested
- retrolaminar block
- Keywords
- Retrolaminar block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrolaminar blockProcedure or surgery
local anesthetic injection on the between the lamina of the vertebra and the paraspinous muscle
| Study group | Role | What they receive |
|---|---|---|
| Retrolaminar block | Retrolaminar block for postoperative pain managment in patients undergoing lumbar herniectomy under general anesthesia Receives: Procedure: retrolaminar block | |
| İntravenous analgesia | İntravenous analgesia for postoperative pain managment in patients undergoing lumbar herniectomy under general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at the forty-eighth hour after the surgery
Secondary outcomes (5)
postoperative analgesic requirements
Opiod and Nonsteroidal Anti-inflammatory Drugs as rescue medication recorded postoperatively.
Measured: at the second hour after the surgery
postoperative analgesic requirements
Opiod and Nonsteroidal Anti-inflammatory Drugs as rescue medication recorded postoperatively.
Measured: at the eighth hour after the surgery
postoperative analgesic requirements
Opiod and Nonsteroidal Anti-inflammatory Drugs as rescue medication recorded postoperatively.
Measured: at the twelfth hour after the surgery
postoperative analgesic requirements
Opiod and Nonsteroidal Anti-inflammatory Drugs as rescue medication recorded postoperatively.
Measured: at the twenty forth hour after the surgery
postoperative analgesic requirements
Opiod and Nonsteroidal Anti-inflammatory Drugs as rescue medication recorded postoperatively.
Measured: at the forty-eighth hour after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start15 Apr 2020
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurcan Kutluer Karaca, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343937
- Sponsor's protocol ID
- Erzincan Binali Y. University
- Status last verified
- Sep 2020
- First submitted
- 8 Apr 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrolaminar Block for Postoperative Analgesia in Lumbar Herniectomy Surgery
- ClinicalTrials.gov ID
- NCT04343937
- Acronym / sponsor ID
- Erzincan Binali Y. University
- Conditions
- Postoperative Pain
- Keywords
- Retrolaminar block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrolaminar block | – | Procedure: retrolaminar blockRetrolaminar block for postoperative pain managment in patients undergoing lumbar herniectomy under general anesthesia |
| İntravenous analgesia | – | –İntravenous analgesia for postoperative pain managment in patients undergoing lumbar herniectomy under general anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients underwent retrolaminar block
Key inclusion criteria (1 listed)
- patients accepted to part in the study
Key exclusion criteria (3 listed)
- patients not accepted to part in the study
- allergic reaction to local anesthetics drugs
- lumbar herniectomy of more than two levels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrolaminar blocklocal anesthetic injection on the between the lamina of the vertebra and the paraspinous muscle | Procedure or surgery | Retrolaminar block |
Primary outcome
postoperative pain: Numeric Pain Rating Scale
Time frame: at the second hour after the 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.
postoperative pain: Numeric Pain Rating Scale
Time frame: at the eighth hour after the surgery
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.
postoperative pain: Numeric Pain Rating Scale
Time frame: at the twelfth hour after the surgery
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.
postoperative pain: Numeric Pain Rating Scale
Time frame: at the twenty forth hour after the surgery
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.
postoperative pain: Numeric Pain Rating Scale
Time frame: at the forty-eighth hour after the surgery
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.
5 secondary outcomes
postoperative analgesic requirements
Time frame: at the second hour after the surgery
postoperative analgesic requirements
Time frame: at the eighth hour after the surgery
postoperative analgesic requirements
Time frame: at the twelfth hour after the surgery
postoperative analgesic requirements
Time frame: at the twenty forth hour after the surgery
postoperative analgesic requirements
Time frame: at the forty-eighth hour after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Erzincan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain: Numeric Pain Rating Scale (time frame: at the second hour after the surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.