PainNCT01466101
Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy
A study testing Pregabalin administration in people with Pain, run by Northwestern University.
Trial summary
Pregabalin will decrease the total amount of opioid required in patients undergoing total abdominal hysterectomy. In addition, pregabalin will decrease the incidence of opioid-related side effects in patients undergoing total abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Pregabalin administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to not given
- 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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA Physical Status 1-2
- Age 18-64
- BMI 18-35
- Scheduled for elective total abdominal hysterectomy (with or without bilateral salpingo-oophorectomy)
- Gender: Female
- Consent: Obtained
Who cannot join
- Patient refusal
- Allergy to study medication(s)
- Preoperative use of gabapentinoids
- Preoperative use of anticonvulsants
- Daily use of analgesics
- Hepatic disease
Show all 16Show fewer
- Renal insufficiency (Cr >2.0)
- Alcohol or drug abuse
- Pregnancy
- Language: Non-English speaking
- Patient expected to remain intubated after procedure
- Dropout:
- Patient request
- Surgeon request
- Allergic reaction to pregabalin
- Surgical procedure significantly altered from scheduled procedure
About this study
Pregabalin will decrease the total amount of opioid required in patients undergoing total abdominal hysterectomy. In addition, pregabalin will decrease the incidence of opioid-related side effects in patients undergoing total abdominal hysterectomy.
- Conditions
- Pain
- Being tested
- Placebo administration, Pregabalin administration
- Keywords
- Hysterectomy, Pain, Pregabalin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo administrationDrug
Administration of placebo
Pregabalin administrationDrug
Administration of pregabalin
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin administration | Active comparator | Administration of pregabalin Receives: Drug: Pregabalin administration |
| Placebo | Placebo comparator | Administration of placebo Receives: Drug: Placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
total hydromorphone consumption
total hydromorphone consumption 24 hours post operatively
Measured: 24 hours
Secondary outcomes (1)
Pain Scores postoperative
Post operative pain scores
Measured: Post operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startJan 2011
Why it stopped: PI left the institution. No subjects screened or enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Altman, Northwestern University
- Investigators
- Christian Altman, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466101
- Sponsor's protocol ID
- STU00025229
- Status last verified
- Feb 2012
- First submitted
- 20 Apr 2010
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North Am. 2005 Mar;23(1):185-202. doi: 10.1016/j.atc.2004.11.010.
PubMed 15763418Tang R, Evans H, Chaput A, Kim C. Multimodal analgesia for hip arthroplasty. Orthop Clin North Am. 2009 Jul;40(3):377-87. doi: 10.1016/j.ocl.2009.04.001.
PubMed 19576406Gilron I. Gabapentin and pregabalin for chronic neuropathic and early postsurgical pain: current evidence and future directions. Curr Opin Anaesthesiol. 2007 Oct;20(5):456-72. doi: 10.1097/ACO.0b013e3282effaa7.
PubMed 17873599Turan A, Karamanlioglu B, Memis D, Usar P, Pamukcu Z, Ture M. The analgesic effects of gabapentin after total abdominal hysterectomy. Anesth Analg. 2004 May;98(5):1370-3, table of contents. doi: 10.1213/01.ane.0000108964.70485.b2.
PubMed 15105217Gilron I, Orr E, Tu D, O'Neill JP, Zamora JE, Bell AC. A placebo-controlled randomized clinical trial of perioperative administration of gabapentin, rofecoxib and their combination for spontaneous and movement-evoked pain after abdominal hysterectomy. Pain. 2005 Jan;113(1-2):191-200. doi: 10.1016/j.pain.2004.10.008.
PubMed 15621380Jokela 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 17507163Jokela 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 18448418Agarwal 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 19727980Brandsborg B, Nikolajsen L, Hansen CT, Kehlet H, Jensen TS. Risk factors for chronic pain after hysterectomy: a nationwide questionnaire and database study. Anesthesiology. 2007 May;106(5):1003-12. doi: 10.1097/01.anes.0000265161.39932.e8.
PubMed 17457133
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT01466101
- Acronym / sponsor ID
- STU00025229
- Conditions
- Pain
- Keywords
- Hysterectomy, Pain, Pregabalin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution. No subjects screened or enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2011
- First posted
- 7 Nov 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.
Pregabalin will decrease the total amount of opioid required in patients undergoing total abdominal hysterectomy. In addition, pregabalin will decrease the incidence of opioid-related side effects in patients undergoing total abdominal hysterectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin administration | Active comparator | Drug: Pregabalin administrationAdministration of pregabalin |
| Placebo | Placebo comparator | Drug: Placebo administrationAdministration of placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ASA Physical Status 1-2
- Age 18-64
- BMI 18-35
- Scheduled for elective total abdominal hysterectomy (with or without bilateral salpingo-oophorectomy)
- Gender: Female
Key exclusion criteria (16 listed)
- Patient refusal
- Allergy to study medication(s)
- Preoperative use of gabapentinoids
- Preoperative use of anticonvulsants
- Daily use of analgesics
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 administrationAdministration of placebo | Drug | Placebo |
| Pregabalin administrationAdministration of pregabalin | Drug | Pregabalin administration |
Primary outcome
total hydromorphone consumption
Time frame: 24 hours
total hydromorphone consumption 24 hours post operatively
1 secondary outcome
Pain Scores postoperative
Time frame: Post operative period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2012.
- Background: PubMed 15763418Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North Am. 2005 Mar;23(1):185-202. doi: 10.1016/j.atc.2004.11.010.
- Background: PubMed 19576406Tang R, Evans H, Chaput A, Kim C. Multimodal analgesia for hip arthroplasty. Orthop Clin North Am. 2009 Jul;40(3):377-87. doi: 10.1016/j.ocl.2009.04.001.
- Background: PubMed 17873599Gilron I. Gabapentin and pregabalin for chronic neuropathic and early postsurgical pain: current evidence and future directions. Curr Opin Anaesthesiol. 2007 Oct;20(5):456-72. doi: 10.1097/ACO.0b013e3282effaa7.
- Background: PubMed 15105217Turan A, Karamanlioglu B, Memis D, Usar P, Pamukcu Z, Ture M. The analgesic effects of gabapentin after total abdominal hysterectomy. Anesth Analg. 2004 May;98(5):1370-3, table of contents. doi: 10.1213/01.ane.0000108964.70485.b2.
- Background: PubMed 15621380Gilron I, Orr E, Tu D, O'Neill JP, Zamora JE, Bell AC. A placebo-controlled randomized clinical trial of perioperative administration of gabapentin, rofecoxib and their combination for spontaneous and movement-evoked pain after abdominal hysterectomy. Pain. 2005 Jan;113(1-2):191-200. doi: 10.1016/j.pain.2004.10.008.
- 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 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 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 17457133Brandsborg B, Nikolajsen L, Hansen CT, Kehlet H, Jensen TS. Risk factors for chronic pain after hysterectomy: a nationwide questionnaire and database study. Anesthesiology. 2007 May;106(5):1003-12. doi: 10.1097/01.anes.0000265161.39932.e8.
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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.
Christian Altman, MD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin administration in people with Pain, run by Northwestern University.
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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
total hydromorphone consumption (time frame: 24 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 NCT01466101, which also lists 10 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 20 Feb 2012.