Pain, PostoperativeNCT01923948
Preoperative Pain Control in Liver Surgery Patients
A study testing Pregabalin in people with Pain, Postoperative and Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
Pregabalin 150mg or placebo are administered 1 hour preoperatively in patients undergoing partial hepatectomy. Postoperatively, patients receive morphine as rescue analgesic. Morphine consumption in the first 48 hours is documented. Postoperative pain is measured by the visual analogue scale (VAS) score. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Postoperative, Hepatocellular Carcinoma
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Dec 2014
- Phase
- Interventional
- 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
Who may be able to join
- patients undergoing partial hepatectomy
Who cannot join
- contraindication against pregabalin
- creatinine > 2.0 mg/dl
- GGT >165, AST >105, ALT >135
- peptic Ulcus
- haemorrhagic diathesis
- angina pectoris, myocardial infarction
Show all 9Show fewer
- stroke
- bronchial asthma
- opioid abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Placebo-Controlled Study of Whether Pre-operative Pregabalin 150 mg Will Improve Pain Control in Patients With Hepatocellular Carcinoma Undergoing Partial Hepatectomy
Pregabalin 150mg or placebo are administered 1 hour preoperatively in patients undergoing partial hepatectomy. Postoperatively, patients receive morphine as rescue analgesic. Morphine consumption in the first 48 hours is documented. Postoperative pain is measured by the visual analogue scale (VAS) score.
Read the detailed description
Methods: In this Randomized Controlled Trial, patients undergoing partial hepatectomy will be administered a single pre-operative dose of Pregabalin or a placebo. Primary endpoints are as follows:
- Post-operative analgesic requirements
- Post-operative VAS scale (rated 0-10)
- Complications
- Post-operative antiemetic requirement
- Length of stay
- Conditions
- Pain, Postoperative, Hepatocellular Carcinoma
- Being tested
- Pregabalin, Placebo (for Pregabalin)
- Keywords
- Hepatocellular carcinoma, Hepatectomy, randomized controlled trials(RCTs), Postoperative Pain
- Medical subject headings
- Pain, Postoperative, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
One 150 mg oral dose of Pregabalin given before surgery
Placebo (for Pregabalin)Drug
Also called Sugar pill manufactured to mimic Pregabalin 150 mg tablet
One oral dose of placebo given before surgery
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Active comparator | Single, 150 mg pre-operative oral dose of Pregabalin Receives: Drug: Pregabalin |
| Sugar Pill | Placebo comparator | Single, placebo pre-operative dose Receives: Drug: Placebo (for Pregabalin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Opioid Consumption
Measured: 48 hours
Secondary outcomes (1)
Postoperative Pain Scores on the Visual Analog Scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- li ai jun, MD, Study chair, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923948
- Sponsor's protocol ID
- EHBHKY2013-001-09
- Status last verified
- Mar 2016
- First submitted
- 9 Aug 2013
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Study of Whether Pre-operative Pregabalin 150 mg Will Improve Pain Control in Patients With Hepatocellular Carcinoma Undergoing Partial Hepatectomy
- ClinicalTrials.gov ID
- NCT01923948
- Acronym / sponsor ID
- EHBHKY2013-001-09
- Conditions
- Pain, Postoperative, Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Hepatectomy, randomized controlled trials(RCTs), Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Aug 2013 (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.
Pregabalin 150mg or placebo are administered 1 hour preoperatively in patients undergoing partial hepatectomy. Postoperatively, patients receive morphine as rescue analgesic. Morphine consumption in the first 48 hours is documented. Postoperative pain is measured by the visual analogue scale (VAS) score.
Detailed description
Methods: In this Randomized Controlled Trial, patients undergoing partial hepatectomy will be administered a single pre-operative dose of Pregabalin or a placebo. Primary endpoints are as follows:
- Post-operative analgesic requirements
- Post-operative VAS scale (rated 0-10)
- Complications
- Post-operative antiemetic requirement
- Length of stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Active comparator | Drug: PregabalinSingle, 150 mg pre-operative oral dose of Pregabalin |
| Sugar Pill | Placebo comparator | Drug: Placebo (for Pregabalin)Single, placebo pre-operative dose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing partial hepatectomy
Key exclusion criteria (9 listed)
- contraindication against pregabalin
- creatinine > 2.0 mg/dl
- GGT >165, AST >105, ALT >135
- peptic Ulcus
- haemorrhagic diathesis
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 |
|---|---|---|
| PregabalinAlso: LyricaOne 150 mg oral dose of Pregabalin given before surgery | Drug | Pregabalin |
| Placebo (for Pregabalin)Also: Sugar pill manufactured to mimic Pregabalin 150 mg tabletOne oral dose of placebo given before surgery | Drug | Sugar Pill |
Primary outcome
Postoperative Opioid Consumption
Time frame: 48 hours
1 secondary outcome
Postoperative Pain Scores on the Visual Analog Scale
Time frame: 24 hours
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 31 Mar 2016.
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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.
li ai jun, MD study chair
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin in people with Pain, Postoperative and Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital 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 1 inclusion and 9 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 31 Mar 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.
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 Opioid Consumption (time frame: 48 hours). 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 31 Mar 2016.