PainPhase 4NCT02729285
Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery
A Phase 4 study testing Ketorolac Tromethamine and scleral buckle in people with Pain, run by Sun Yat-sen University at 1 site in China.
Trial summary
The scleral buckle surgery is an effective way in treating retinal detachment (RD) patients. Retrobulbar block has been proved effective in scleral buckle surgery. Though retrobulbar anesthesia saves operative time and money compared to general analgesia, the intraoperative pain is frequent and a proportion of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Ketorolac Tromethamine and scleral buckle
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Oct 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consent of the patient or legal guardian
- 18 years or above
- normal height and weight
- ASA class I, II
- elective surgery
- surgery time within 60min
- understanding of the verbal numerical rating score (0-10)
Who cannot join
- history of ocular surgery, trauma or infection
- intraoperative complications
- glaucoma or ocular hypertension (> 20 mmHg)
- diabetic retinopathy
- diagnosis of asthma or coagulopathy
- chronic pain syndromes
Show all 13Show fewer
- history of peptic ulceration, liver or hematologic disease
- history of chronic use of analgesics, sedatives, opioids or steroids
- history of drug or alcohol abuse
- history of systemic disease
- sexually transmitted disease (STD)
- Pregnancy, lactation;
- cognitive impairment or psychiatric illness;
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Preoperative Ketorolac for Intraoperative and Postoperative Pain Management in Scleral Buckling Surgery Under Retrobulbar Block Anesthesia: A Prospective, Randomized, Controlled Study
The scleral buckle surgery is an effective way in treating retinal detachment (RD) patients. Retrobulbar block has been proved effective in scleral buckle surgery. Though retrobulbar anesthesia saves operative time and money compared to general analgesia, the intraoperative pain is frequent and a proportion of postoperative pain is often ignored. Ketorolac has been demonstrated to be a preemptive analgesia in other diseases such as adenotonsillectomy, posterior lumbar spinal fusion, laser-assisted subepithelial keratectomy (LASEK), and so forth. The aim of the investigators study is to determine the safety and preemptive analgesic effect of ketorolac in the perioperative pain control of patients undergoing RD surgery under retrobulbar anesthesia.
- Conditions
- Pain
- Being tested
- Ketorolac Tromethamine, placebo, scleral buckle
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Also called ketorolac
On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 min before scleral buckle surgery.
placeboDrug
Also called disambiguation
On operation day, the patients were randomly assigned to receive placebo 30 min before scleral buckle surgery.
scleral buckleProcedure or surgery
Surgical procedure of scleral buckle under retrobulbar block anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac Tromethamine | Experimental | On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 minutes before scleral buckle surgery. Receives: Drug: Ketorolac Tromethamine; Procedure: scleral buckle |
| placebo | Placebo comparator | On operation day, the patients were randomly assigned to receive placebo before scleral buckle surgery. Receives: Drug: placebo; Procedure: scleral buckle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score using numerical rating scale (NRS)
Measured: preoperative
Pain score using numerical rating scale (NRS)
any pain during the whole operation time
Measured: intraoperative
Pain score using numerical rating scale (NRS)
Measured: immediately after operation
Pain score using numerical rating scale (NRS)
Measured: at 4 hours postoperatively
Pain score using numerical rating scale (NRS)
Measured: at 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionOct 2014
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 PainStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Lu, Sun Yat-sen University
- Investigators
- Lu Lin, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729285
- Sponsor's protocol ID
- 2014MEKY042
- Status last verified
- Sep 2016
- First submitted
- 27 Mar 2016
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Chen X, Liu B, Liang X, Li J, Li T, Li Y, Yu X, Lyu C, Zhao X, Tanumiharjo S, Jin C, Lu L. The Combination of Ketorolac with Local Anesthesia for Pain Control in Day Care Retinal Detachment Surgery: A Randomized Controlled Trial. J Ophthalmol. 2017;2017:3464693. doi: 10.1155/2017/3464693. Epub 2017 Jul 9.
PubMed 28770108
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ketorolac for Intraoperative and Postoperative Pain Management in Scleral Buckling Surgery Under Retrobulbar Block Anesthesia: A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT02729285
- Acronym / sponsor ID
- 2014MEKY042
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Apr 2016 (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.
The scleral buckle surgery is an effective way in treating retinal detachment (RD) patients. Retrobulbar block has been proved effective in scleral buckle surgery. Though retrobulbar anesthesia saves operative time and money compared to general analgesia, the intraoperative pain is frequent and a proportion of postoperative pain is often ignored. Ketorolac has been demonstrated to be a preemptive analgesia in other diseases such as adenotonsillectomy, posterior lumbar spinal fusion, laser-assisted subepithelial keratectomy (LASEK), and so forth. The aim of the investigators study is to determine the safety and preemptive analgesic effect of ketorolac in the perioperative pain control of patients undergoing RD surgery under retrobulbar anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac Tromethamine | Experimental | Drug: Ketorolac Tromethamine, Procedure: scleral buckleOn operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 minutes before scleral buckle surgery. |
| placebo | Placebo comparator | Drug: placebo, Procedure: scleral buckleOn operation day, the patients were randomly assigned to receive placebo before scleral buckle surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- consent of the patient or legal guardian
- 18 years or above
- normal height and weight
- ASA class I, II
- elective surgery
Key exclusion criteria (13 listed)
- history of ocular surgery, trauma or infection
- intraoperative complications
- glaucoma or ocular hypertension (> 20 mmHg)
- diabetic retinopathy
- diagnosis of asthma or coagulopathy
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 |
|---|---|---|
| Ketorolac TromethamineAlso: ketorolacOn operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 min before scleral buckle surgery. | Drug | Ketorolac Tromethamine |
| placeboAlso: disambiguationOn operation day, the patients were randomly assigned to receive placebo 30 min before scleral buckle surgery. | Drug | placebo |
| scleral buckleSurgical procedure of scleral buckle under retrobulbar block anesthesia | Procedure or surgery | Ketorolac Tromethamine, placebo |
Primary outcome
Pain score using numerical rating scale (NRS)
Time frame: preoperative
Pain score using numerical rating scale (NRS)
Time frame: intraoperative
any pain during the whole operation time
Pain score using numerical rating scale (NRS)
Time frame: immediately after operation
Pain score using numerical rating scale (NRS)
Time frame: at 4 hours postoperatively
Pain score using numerical rating scale (NRS)
Time frame: at 24 hours postoperatively
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 22 Sep 2016.
- Derived from this study: PubMed 28770108Chen X, Liu B, Liang X, Li J, Li T, Li Y, Yu X, Lyu C, Zhao X, Tanumiharjo S, Jin C, Lu L. The Combination of Ketorolac with Local Anesthesia for Pain Control in Day Care Retinal Detachment Surgery: A Randomized Controlled Trial. J Ophthalmol. 2017;2017:3464693. doi: 10.1155/2017/3464693. Epub 2017 Jul 9.
- Individual participant dataSharing planned: Undecided
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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.
Lu Lin principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
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 Ketorolac Tromethamine and scleral buckle in people with Pain, run by Sun Yat-sen University at 1 site in China.
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 7 inclusion and 13 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 22 Sep 2016. 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 China. 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?
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?
Pain score using numerical rating scale (NRS) (time frame: preoperative). 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?
On the ClinicalTrials.gov record for NCT02729285, 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 22 Sep 2016.