Postoperative PainPhase 4NCT01117610
A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery
A Phase 4 study testing Ropivacaine (epidural injection) in people with Postoperative Pain, run by Chung-Ang University Hospital at 1 site in South Korea.
Trial summary
This prospective randomized study aims to evaluate the effectiveness of epidural injection of ropivacaine on the relief of pain in patients undergoing laminectomy. Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine (epidural injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Apr 2011
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- laminectomy
Who cannot join
- r/o infection
- reoperation
- mental change
- allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
South Korea1 site
ChungAng University
Seoul, 156-755
SeongDeok Kim, M.D. & Ph.D., +82-2-6299-2571, ksdeok@cau.ac.kr
About this study
Official title: A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery: A Prospective Randomized Study
This prospective randomized study aims to evaluate the effectiveness of epidural injection of ropivacaine on the relief of pain in patients undergoing laminectomy.
Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.
Patients in group C will receive no medication intraoperatively, and patients in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.
Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4,12,24,48 hour postoperatively.
Read the detailed description
Patients in group I will receive 0.1% ropivacaine 10 ml before skin incision under guide of C-arm.
- Conditions
- Postoperative Pain
- Being tested
- Placebo (one of medication), Ropivacaine (epidural injection)
- Keywords
- pain, preemptive, postoperative, epidural injection, laminectomy
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (one of medication)Drug
Also called patient in group C will receive none of medication
patients in Group C will receive none of medication preoperatively and intraoperatively
Ropivacaine (epidural injection)Drug
Also called epidural injection
patient in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.
| Study group | Role | What they receive |
|---|---|---|
| epidural injection (group I) | Active comparator | patients in Group I will receive epidural injection of 0.1% ropivacaine 10 ml before skin incision. Receives: Drug: Ropivacaine (epidural injection) |
| epidural injection group (group C) | Placebo comparator | control group will receive no medication preoperatively and during operation Receives: Drug: Placebo (one of medication) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale 4hour
Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.
To check the severity of pain VAS will be measured at post op 4hour.
Measured: post op 4hour
Secondary outcomes (11)
visual analogue scale 24hour
Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.
To check the severity of pain VAS will be measured at post op 24hour.
Measured: Post Op 24 hour
visual analogue scale 12 hour
Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.
To check the severity of pain VAS will be measured at post op 12 hour.
Measured: Post op 12 hour
Visual analogue scale 48hour
Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.
To check the severity of pain VAS will be measured at post op 48 hour.
Measured: Post Op 48hour
Opioid consumption 4hour
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 4hour will be measured.
Measured: Post Op 4hour
Opioid consumption 24hour
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from 12 hour to post op 24 hour will be measured.
Measured: Post op 24 hour
Opioid consumption 12 hour
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from post op 4hour to post op 12 hour will be measured.
Measured: Post Op 12 hour
Opioid consumption 48hour
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from post op 24 hour to post op 48 hour will be measured
Measured: Post Op 48 hour
FPB 4 hour
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 4 hour will be measured.
Measured: Post Op 4 hour
FPB 12 hour
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) from post op 4 hour to post op 12 hour will be measured.
Measured: post op 12 hour
FPB 24 hour
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 12 hour to post op 24 hour will be measured.
Measured: Post Op 24 hour
FPB 48 hour
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 24 hour to post op 48 hour will be measured.
Measured: Post Op 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kwang-Sup Song, M.D. & Ph.D., Study director, ChungAng UniversityHyun Kang, M.D. & Ph.D., Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117610
- Sponsor's protocol ID
- ChungAngUH
- Status last verified
- May 2010
- First submitted
- 4 May 2010
- Last updated
- 5 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kang H, Jung HJ, Lee JS, Yang JJ, Shin HY, Song KS. Early postoperative analgesic effects of a single epidural injection of ropivacaine administered preoperatively in posterior lumbar interbody spinal arthrodesis: a pilot randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):393-9. doi: 10.2106/JBJS.K.01729.
PubMed 23467861
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01117610
- Acronym / sponsor ID
- ChungAngUH
- Conditions
- Postoperative Pain
- Keywords
- pain, preemptive, postoperative, epidural injection, laminectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 5 May 2010 (estimated)
- 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 prospective randomized study aims to evaluate the effectiveness of epidural injection of ropivacaine on the relief of pain in patients undergoing laminectomy.
Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.
Patients in group C will receive no medication intraoperatively, and patients in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.
Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4,12,24,48 hour postoperatively.
Detailed description
Patients in group I will receive 0.1% ropivacaine 10 ml before skin incision under guide of C-arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidural injection (group I) | Active comparator | Drug: Ropivacaine (epidural injection)patients in Group I will receive epidural injection of 0.1% ropivacaine 10 ml before skin incision. |
| epidural injection group (group C) | Placebo comparator | Drug: Placebo (one of medication)control group will receive no medication preoperatively and during operation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- laminectomy
Key exclusion criteria (4 listed)
- r/o infection
- reoperation
- mental change
- allergy to local anesthetics
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 |
|---|---|---|
| Placebo (one of medication)Also: patient in group C will receive none of medicationpatients in Group C will receive none of medication preoperatively and intraoperatively | Drug | epidural injection group (group C) |
| Ropivacaine (epidural injection)Also: epidural injectionpatient in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision. | Drug | epidural injection (group I) |
Primary outcome
Visual analogue scale 4hour
Time frame: post op 4hour
Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 4hour.
11 secondary outcomes
visual analogue scale 24hour
Time frame: Post Op 24 hour
visual analogue scale 12 hour
Time frame: Post op 12 hour
Visual analogue scale 48hour
Time frame: Post Op 48hour
Opioid consumption 4hour
Time frame: Post Op 4hour
Opioid consumption 24hour
Time frame: Post op 24 hour
Opioid consumption 12 hour
Time frame: Post Op 12 hour
Opioid consumption 48hour
Time frame: Post Op 48 hour
FPB 4 hour
Time frame: Post Op 4 hour
FPB 12 hour
Time frame: post op 12 hour
FPB 24 hour
Time frame: Post Op 24 hour
FPB 48 hour
Time frame: Post Op 48 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2010.
- Derived from this study: PubMed 23467861Kang H, Jung HJ, Lee JS, Yang JJ, Shin HY, Song KS. Early postoperative analgesic effects of a single epidural injection of ropivacaine administered preoperatively in posterior lumbar interbody spinal arthrodesis: a pilot randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):393-9. doi: 10.2106/JBJS.K.01729.
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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.
Kwang-Sup Song, M.D. & Ph.D. study director
ChungAng University
Hyun Kang, M.D. & Ph.D. principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine (epidural injection) in people with Postoperative Pain, run by Chung-Ang University Hospital at 1 site in South Korea.
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 4 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: status not confirmed, as of the sponsor's last update on 5 May 2010. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale 4hour (time frame: post op 4hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01117610, which also lists 1 linked publication.
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 5 May 2010.