Pain PostoperativeNCT01321801
Pregabalin and Analgesia After Laparoscopic Cholecystectomy
A study testing Pregabalin in people with Pain Postoperative, run by Larissa University Hospital at 1 site in Greece.
Trial summary
The purpose of this study is to evaluate how effective is the preoperative administration of pregabalin 600mg, to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Postoperative
- 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
- 50 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2009to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-II
Who cannot join
- Renal or hepatic insufficiency
- Alcohol or drugs abuse
- History of chronic pain or daily intake of analgesics
- Uncontrolled medical disease (hypertension, diabetes) and cardiovascular problems. Psychiatric disorders
- Inability of patients to use PCA pump
- History of intake of non-steroidal anti-inflammatory drugs the last 24 hours before surgery,use of drainage after the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Use of Pregabalin and Analgesia Levels After Laparoscopic Cholecystectomy
The purpose of this study is to evaluate how effective is the preoperative administration of pregabalin 600mg, to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy.
Read the detailed description
Acute pain frequently occurs during the postoperative period.Not treated acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of pregabalin, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that pregabalin may have a role in the post operative pain management, as an adjunct. Pregabalin is an anticonvulsant and anxiolytic drug, which have a more favorable pharmacokinetic profile from its predecessor gabapentin.
Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.
- Conditions
- Pain Postoperative
- Being tested
- Pregabalin, placebo
- Keywords
- Pregabalin, Laparoscopic cholecystectomy, Postoperative pain, Opioid consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
Preoperative administration of pregabalin 600mg
placeboDrug
Preoperative administration of a matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Active comparator | Preoperative administration of pregabalin 600mg to patients undergo laparoscopic cholecystectomy.Patients receive oral Pregabalin 300 mg the night before the surgery, and another one dose of 300 mg 1 hour prior to surgery Receives: Drug: Pregabalin |
| Placebo | Placebo comparator | Preoperative administration of placebo to patients undergo laparoscopic cholecystectomy.Patients receive oral Placebo the night before the surgery, and another one dose 1 hour prior to surgery. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
VAS = visual analoque scale 0-10 mm (0=no pain to 10= worst imaginable pain).Measured on the arrival of the patient to the recovery room(0 hrs), one hour later, and then every eight hours until the completion of 24 hours after operation.
Measured: Every 8 hours
Secondary outcomes (2)
Side- effects
To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, dizziness, blurred vision, lack of concentration, shoulder pain, sedation, and respiratory depression.
Measured: 0,1, 8, 16 & 24 hours
Postoperative opioid consumption
The total dose of morphine was calculated as mg and included opioids administered by PCA pump.On arrival in the PACU patients received morphine via PCA pump.Postoperative morphine requirements were assessed on the arrival of the patient to the recovery room (0 hrs), one hour later and then every eight hours, until the completion of 24 hours after operation.
Measured: 0,1, 8, 16 & 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startNov 2009
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chamaidi Sarakatsianou, Larissa University Hospital
- Investigators
- Chamaidi Sarakatsianou, RN, MSc, Principal investigator, University Hospital of LarissaGeorge Tzovaras, MD, Study chair, University Hospital of LarissaGeorgia Stamatiou, MD, Study director, University Hospital of LarissaElena Theodorou, MD, Study chair, University Hospital of LarissaStavroula Georgopoulou, MD, Study chair, University Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321801
- Sponsor's protocol ID
- UHL25872/ 08/17/09
- Status last verified
- Jan 2013
- First submitted
- 23 Mar 2011
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain. 2008 Jan;134(1-2):106-12. doi: 10.1016/j.pain.2007.04.002. Epub 2007 May 15.
PubMed 17507163White PF, Tufanogullari B, Taylor J, Klein K. The effect of pregabalin on preoperative anxiety and sedation levels: a dose-ranging study. Anesth Analg. 2009 Apr;108(4):1140-5. doi: 10.1213/ane.0b013e31818d40ce.
PubMed 19299776Paech MJ, Goy R, Chua S, Scott K, Christmas T, Doherty DA. A randomized, placebo-controlled trial of preoperative oral pregabalin for postoperative pain relief after minor gynecological surgery. Anesth Analg. 2007 Nov;105(5):1449-53, table of contents. doi: 10.1213/01.ane.0000286227.13306.d7.
PubMed 17959981Mathiesen O, Rasmussen ML, Dierking G, Lech K, Hilsted KL, Fomsgaard JS, Lose G, Dahl JB. Pregabalin and dexamethasone in combination with paracetamol for postoperative pain control after abdominal hysterectomy. A randomized clinical trial. Acta Anaesthesiol Scand. 2009 Feb;53(2):227-35. doi: 10.1111/j.1399-6576.2008.01821.x. Epub 2008 Dec 6.
PubMed 19076108Mathiesen O, Jacobsen LS, Holm HE, Randall S, Adamiec-Malmstroem L, Graungaard BK, Holst PE, Hilsted KL, Dahl JB. Pregabalin and dexamethasone for postoperative pain control: a randomized controlled study in hip arthroplasty. Br J Anaesth. 2008 Oct;101(4):535-41. doi: 10.1093/bja/aen215. Epub 2008 Jul 23.
PubMed 18653493Bisgaard T. Analgesic treatment after laparoscopic cholecystectomy: a critical assessment of the evidence. Anesthesiology. 2006 Apr;104(4):835-46. doi: 10.1097/00000542-200604000-00030.
PubMed 16571981Chang SH, Lee HW, Kim HK, Kim SH, Kim DK. An evaluation of perioperative pregabalin for prevention and attenuation of postoperative shoulder pain after laparoscopic cholecystectomy. Anesth Analg. 2009 Oct;109(4):1284-6. doi: 10.1213/ane.0b013e3181b4874d. Epub 2009 Jul 29.
PubMed 19641054Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. doi: 10.1093/bja/aen244. Epub 2008 Aug 20.
PubMed 18716003Cabrera Schulmeyer MC, de la Maza J, Ovalle C, Farias C, Vives I. Analgesic effects of a single preoperative dose of pregabalin after laparoscopic sleeve gastrectomy. Obes Surg. 2010 Dec;20(12):1678-81. doi: 10.1007/s11695-009-9944-1. Epub 2009 Aug 29.
PubMed 19727980Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. Premedication with pregabalin 75 or 150 mg with ibuprofen to control pain after day-case gynaecological laparoscopic surgery. Br J Anaesth. 2008 Jun;100(6):834-40. doi: 10.1093/bja/aen098. Epub 2008 Apr 29.
PubMed 18448418Peng PW, Li C, Farcas E, Haley A, Wong W, Bender J, Chung F. Use of low-dose pregabalin in patients undergoing laparoscopic cholecystectomy. Br J Anaesth. 2010 Aug;105(2):155-61. doi: 10.1093/bja/aeq116. Epub 2010 Jun 25.
PubMed 20581215Ittichaikulthol W, Virankabutra T, Kunopart M, Khamhom W, Putarawuthichai P, Rungphet S. Effects of pregabalin on post operative morphine consumption and pain after abdominal hysterectomy with/without salphingo-oophorectomy: a randomized, double-blind trial. J Med Assoc Thai. 2009 Oct;92(10):1318-23.
PubMed 19845240Gajraj NM. Pregabalin: its pharmacology and use in pain management. Anesth Analg. 2007 Dec;105(6):1805-15. doi: 10.1213/01.ane.0000287643.13410.5e.
PubMed 18042886Sarakatsianou C, Theodorou E, Georgopoulou S, Stamatiou G, Tzovaras G. Effect of pre-emptive pregabalin on pain intensity and postoperative morphine consumption after laparoscopic cholecystectomy. Surg Endosc. 2013 Jul;27(7):2504-11. doi: 10.1007/s00464-012-2769-3. Epub 2013 Jan 24.
PubMed 23344509
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Use of Pregabalin and Analgesia Levels After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01321801
- Acronym / sponsor ID
- UHL25872/ 08/17/09
- Conditions
- Pain Postoperative
- Keywords
- Pregabalin, Laparoscopic cholecystectomy, Postoperative pain, Opioid consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 24 Mar 2011 (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 purpose of this study is to evaluate how effective is the preoperative administration of pregabalin 600mg, to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy.
Detailed description
Acute pain frequently occurs during the postoperative period.Not treated acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of pregabalin, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that pregabalin may have a role in the post operative pain management, as an adjunct. Pregabalin is an anticonvulsant and anxiolytic drug, which have a more favorable pharmacokinetic profile from its predecessor gabapentin.
Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Active comparator | Drug: PregabalinPreoperative administration of pregabalin 600mg to patients undergo laparoscopic cholecystectomy.Patients receive oral Pregabalin 300 mg the night before the surgery, and another one dose of 300 mg 1 hour prior to surgery |
| Placebo | Placebo comparator | Drug: placeboPreoperative administration of placebo to patients undergo laparoscopic cholecystectomy.Patients receive oral Placebo the night before the surgery, and another one dose 1 hour prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I-II
Key exclusion criteria (6 listed)
- Renal or hepatic insufficiency
- Alcohol or drugs abuse
- History of chronic pain or daily intake of analgesics
- Uncontrolled medical disease (hypertension, diabetes) and cardiovascular problems. Psychiatric disorders
- Inability of patients to use PCA pump
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: LyricaPreoperative administration of pregabalin 600mg | Drug | Pregabalin |
| placeboPreoperative administration of a matching placebo | Drug | Placebo |
Primary outcome
Postoperative pain
Time frame: Every 8 hours
VAS = visual analoque scale 0-10 mm (0=no pain to 10= worst imaginable pain).Measured on the arrival of the patient to the recovery room(0 hrs), one hour later, and then every eight hours until the completion of 24 hours after operation.
2 secondary outcomes
Side- effects
Time frame: 0,1, 8, 16 & 24 hours
Postoperative opioid consumption
Time frame: 0,1, 8, 16 & 24 hour
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 29 Jan 2013.
- Background: PubMed 17507163Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain. 2008 Jan;134(1-2):106-12. doi: 10.1016/j.pain.2007.04.002. Epub 2007 May 15.
- Background: PubMed 19299776White PF, Tufanogullari B, Taylor J, Klein K. The effect of pregabalin on preoperative anxiety and sedation levels: a dose-ranging study. Anesth Analg. 2009 Apr;108(4):1140-5. doi: 10.1213/ane.0b013e31818d40ce.
- Background: PubMed 17959981Paech MJ, Goy R, Chua S, Scott K, Christmas T, Doherty DA. A randomized, placebo-controlled trial of preoperative oral pregabalin for postoperative pain relief after minor gynecological surgery. Anesth Analg. 2007 Nov;105(5):1449-53, table of contents. doi: 10.1213/01.ane.0000286227.13306.d7.
- Background: PubMed 19076108Mathiesen O, Rasmussen ML, Dierking G, Lech K, Hilsted KL, Fomsgaard JS, Lose G, Dahl JB. Pregabalin and dexamethasone in combination with paracetamol for postoperative pain control after abdominal hysterectomy. A randomized clinical trial. Acta Anaesthesiol Scand. 2009 Feb;53(2):227-35. doi: 10.1111/j.1399-6576.2008.01821.x. Epub 2008 Dec 6.
- Background: PubMed 18653493Mathiesen O, Jacobsen LS, Holm HE, Randall S, Adamiec-Malmstroem L, Graungaard BK, Holst PE, Hilsted KL, Dahl JB. Pregabalin and dexamethasone for postoperative pain control: a randomized controlled study in hip arthroplasty. Br J Anaesth. 2008 Oct;101(4):535-41. doi: 10.1093/bja/aen215. Epub 2008 Jul 23.
- Background: PubMed 16571981Bisgaard T. Analgesic treatment after laparoscopic cholecystectomy: a critical assessment of the evidence. Anesthesiology. 2006 Apr;104(4):835-46. doi: 10.1097/00000542-200604000-00030.
- Background: PubMed 19641054Chang SH, Lee HW, Kim HK, Kim SH, Kim DK. An evaluation of perioperative pregabalin for prevention and attenuation of postoperative shoulder pain after laparoscopic cholecystectomy. Anesth Analg. 2009 Oct;109(4):1284-6. doi: 10.1213/ane.0b013e3181b4874d. Epub 2009 Jul 29.
- Background: PubMed 18716003Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. doi: 10.1093/bja/aen244. Epub 2008 Aug 20.
- Background: PubMed 19727980Cabrera Schulmeyer MC, de la Maza J, Ovalle C, Farias C, Vives I. Analgesic effects of a single preoperative dose of pregabalin after laparoscopic sleeve gastrectomy. Obes Surg. 2010 Dec;20(12):1678-81. doi: 10.1007/s11695-009-9944-1. Epub 2009 Aug 29.
- Background: PubMed 18448418Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. Premedication with pregabalin 75 or 150 mg with ibuprofen to control pain after day-case gynaecological laparoscopic surgery. Br J Anaesth. 2008 Jun;100(6):834-40. doi: 10.1093/bja/aen098. Epub 2008 Apr 29.
- Background: PubMed 20581215Peng PW, Li C, Farcas E, Haley A, Wong W, Bender J, Chung F. Use of low-dose pregabalin in patients undergoing laparoscopic cholecystectomy. Br J Anaesth. 2010 Aug;105(2):155-61. doi: 10.1093/bja/aeq116. Epub 2010 Jun 25.
- Background: PubMed 19845240Ittichaikulthol W, Virankabutra T, Kunopart M, Khamhom W, Putarawuthichai P, Rungphet S. Effects of pregabalin on post operative morphine consumption and pain after abdominal hysterectomy with/without salphingo-oophorectomy: a randomized, double-blind trial. J Med Assoc Thai. 2009 Oct;92(10):1318-23.
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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.
Chamaidi Sarakatsianou, RN, MSc principal investigator
University Hospital of Larissa
George Tzovaras, MD study chair
University Hospital of Larissa
Georgia Stamatiou, MD study director
University Hospital of Larissa
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, run by Larissa University Hospital at 1 site in Greece.
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 6 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 29 Jan 2013. 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 Greece. 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 pain (time frame: Every 8 hours). 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 NCT01321801, which also lists 14 linked publications.
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 29 Jan 2013.