Planned Abdominal HysterectomyPhase 4NCT00209872
Optimal Multimodal Analgesia in Abdominal Hysterectomy
A Phase 4 study testing Gabapentin, Lidocaine and S-ketamine in people with Planned Abdominal Hysterectomy, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to test the current standard of care (SOC) treatment for abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional perioperative analgesics in terms of postoperative abilities, postoperative nausea and vomiting (PONV), pain and discharge time from the PACU… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Planned Abdominal Hysterectomy
- What is being tested?
- Gabapentin, Lidocaine and S-ketamine
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2005to not given
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned abdominal hysterectomy with or without BSO
- Age above 18 years
- Written informed consent
- American Society of Anesthesiologists (ASA) class I-III
Who cannot join
- Planned vaginal or laparoscopic hysterectomy
- Hysterectomy as part of other surgery
- Allergy to part of the treatment regimen
- Previous reactions to opioids (nausea, cognition)
- Previous inability to place correct epidural catheter
- Severe state anxiety according to the OCAP or STAI
Show all 11Show fewer
- ASA class IV
- Dependency on alcohol, opioids or central stimulants
- Chronic pain condition
- Hemorrhagic diathesis
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Anaesthesia, Hvidovre Hospital
Copenhagen, Hvidovre, 2650
Kenneth Jensen, M.D., +45 36 32 62 90, kenneth.jensen@hh.hosp.dk
Kenneth Jensen, M.D.
About this study
The purpose of this study is to test the current standard of care (SOC) treatment for abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional perioperative analgesics in terms of postoperative abilities, postoperative nausea and vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit).
Read the detailed description
Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups, for patients admitted for planned abdominal hysterectomy with or without BSO:
- A: standard of care (SOC) receiving paracetamol, celecoxib, epidural analgesia, dexamethasone, ondansetron and droperidol, and general anaesthesia with propofol, remifentanil and cisatracurium
- B: SOC with sham epidural analgesia, preoperative gabapentin, intraoperative lidocaine, s-ketamine and sufentanil
- Conditions
- Planned Abdominal Hysterectomy
- Being tested
- Gabapentin, Lidocaine, S-ketamine, Epidural analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
LidocaineDrug
S-ketamineDrug
Epidural analgesiaProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative abilities over time
Discharge time from PACU according to fixed criteria
Consumption of analgesics and antiemetics in the PACU
Secondary outcomes (3)
Degree of nursing requirements at the PACU
General tolerability of the regimes
Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Planned Abdominal HysterectomyStudies 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
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth Jensen, M.D., Principal investigator, Dept. of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, DenmarkClaus Lund, Dr. Med. Sci., Study chair, Dept. of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209872
- Sponsor's protocol ID
- OMA-AH01
- Other IDs
- eudraCT # 2005-003595-38
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 7 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Multimodal Analgesia in Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT00209872
- Acronym / sponsor ID
- OMA-AH01
- Conditions
- Planned Abdominal Hysterectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Oct 2005
- First posted
- 21 Sep 2005 (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 test the current standard of care (SOC) treatment for abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional perioperative analgesics in terms of postoperative abilities, postoperative nausea and vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit).
Detailed description
Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups, for patients admitted for planned abdominal hysterectomy with or without BSO:
- A: standard of care (SOC) receiving paracetamol, celecoxib, epidural analgesia, dexamethasone, ondansetron and droperidol, and general anaesthesia with propofol, remifentanil and cisatracurium
- B: SOC with sham epidural analgesia, preoperative gabapentin, intraoperative lidocaine, s-ketamine and sufentanil
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned abdominal hysterectomy with or without BSO
- Age above 18 years
- Written informed consent
- American Society of Anesthesiologists (ASA) class I-III
Key exclusion criteria (11 listed)
- Planned vaginal or laparoscopic hysterectomy
- Hysterectomy as part of other surgery
- Allergy to part of the treatment regimen
- Previous reactions to opioids (nausea, cognition)
- Previous inability to place correct epidural catheter
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 |
|---|---|---|
| Gabapentin | Drug | – |
| Lidocaine | Drug | – |
| S-ketamine | Drug | – |
| Epidural analgesia | Procedure or surgery | – |
Primary outcome
Postoperative abilities over time
Discharge time from PACU according to fixed criteria
Consumption of analgesics and antiemetics in the PACU
3 secondary outcomes
Degree of nursing requirements at the PACU
General tolerability of the regimes
Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2007.
- URL looking into anaesthesia and surgery for abdominal hysterectomyLink provided by the sponsor.
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Recruiting
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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.
Kenneth Jensen, M.D. principal investigator
Dept. of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark
Claus Lund, Dr. Med. Sci. study chair
Dept. of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark
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 Gabapentin, Lidocaine and S-ketamine in people with Planned Abdominal Hysterectomy, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 11 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 7 Nov 2007. 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 Denmark. 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. 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?
Contact Kenneth Jensen, M.D. (+45 36 32 62 90, kenneth.jensen@hh.hosp.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative abilities over time. The study lists 3 primary outcomes in all. 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 7 Nov 2007.