HysterectomyPhase 4NCT01106547
The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy
A Phase 4 study testing Methylprednisolone 125mg and Sodium Chloride 2 ml in people with Hysterectomy and Methylprednisolone, run by Holbaek Sygehus at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the effect of 125 mg methylprednisolone, given intravenously 60-90 minutes before abdominal surgery,on the postoperative rehabilitation after abdominal hysterectomy.Sodium Chloride is the placebo. The following parameters are registered: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy, Methylprednisolone, Postoperative Pain
- What is being tested?
- Methylprednisolone 125mg and Sodium Chloride 2 ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Oct 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients having an abdominal hysterectomy on a benign indication.
- Patients who speak and understand Danish.
- Patients who can give informed consent.
Who cannot join
- Diabetics
- Regular use of glucocorticoids, opioids or tranquilizers
- Regular treatment with immunosuppressives
- Alcohol or drug abuse
- Morphine intolerance
- Age under 18
Show all 11Show fewer
- Chronic pain disease eg fibromyalgia, rheumatoid arthritis
- Malign indication for hysterectomy
- BMI over 35
- Decreased kidney function
- ASA III or IV
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Gynaechology and Obstetrics, Holbæk Sygehus
Holbæk, 4300
About this study
Official title: The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study
The purpose of this study is to evaluate the effect of 125 mg methylprednisolone, given intravenously 60-90 minutes before abdominal surgery,on the postoperative rehabilitation after abdominal hysterectomy.Sodium Chloride is the placebo. The following parameters are registered:
- Pain 3, 6 and 24 hours postoperatively and 2-7 days after surgery.
- The postoperative use of additional analgesics.
- Inflammatory parameters before and after surgery.
- Time until mobilization.
- Time until discharge.
- Conditions
- Hysterectomy, Methylprednisolone, Postoperative Pain
- Being tested
- Methylprednisolone 125mg, Sodium Chloride 2 ml
- Keywords
- abdominal hysterectomy, glucocorticoids, rehabilitation, postoperative pain, analgetics
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone 125mgDrug
Also called Solu-medrol
Single dose 60-90 minutes preoperatively
Sodium Chloride 2 mlDrug
Single dose 60-90 min preoperatively
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Experimental | Not described Receives: Drug: Methylprednisolone 125mg |
| placebo/sodium chloride | Placebo comparator | Not described Receives: Drug: Sodium Chloride 2 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain 6 hours postoperatively
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 6 hours postoperatively
Measured: 6 hours postoperatively
Pain 3 hours postoperatively
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 3 hours postoperatively
Measured: 3 hours postoperatively
Pain 24 hours postoperatively
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 24 hours postoperatively
Measured: 24 hours postoperatively
Pain
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest once daily from 2nd-7th postoperative day
Measured: 2-7 days postoperatively
Secondary outcomes (8)
Use of additional analgesics
The use of other analgesics than paracetamol and diclofenac postoperatively - dosage.
Measured: 0-2 days
Postoperative nausea
Numbers of vomits
Measured: until 2 days postoperatively
Use of antiemetics
Dosage of antiemetics during the first 2 days postoperatively
Measured: 0-2 days postoperatively
Time until mobilization
Measured: 0-2 days
Time until discharge after surgery
Measured: 0-10 days
Inflammatory parameters
CRP measured 0-24 hours preoperatively before injection of project medicine.
Measured: 0-24 h preoperatively
Adverse effects
Measured: 0-2 days
Inflammatory parameter
CRP measured at 10am on the first and second postoperative day.
Measured: 1-2 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Aabakke, Holbaek Sygehus
- Investigators
- Niels Jørgen Secher, Professor, Study chair, Department of Obstetrics, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106547
- Sponsor's protocol ID
- Hysterektomistudiet
- Other IDs
- SJ-127, 2010-018448-15
- Status last verified
- Oct 2011
- First submitted
- 14 Apr 2010
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lidegaard O, Hammerum MS. Landspatientregisteret til kvalitetssikring i det gynækologiske speciale. 2002.
Danish hysterektomy database - year report 2004.
Hall GM, Peerbhoy D, Shenkin A, Parker CJ, Salmon P. Relationship of the functional recovery after hip arthroplasty to the neuroendocrine and inflammatory responses. Br J Anaesth. 2001 Oct;87(4):537-42. doi: 10.1093/bja/87.4.537.
PubMed 11878721Henzi I, Walder B, Tramer MR. Dexamethasone for the prevention of postoperative nausea and vomiting: a quantitative systematic review. Anesth Analg. 2000 Jan;90(1):186-94. doi: 10.1097/00000539-200001000-00038.
PubMed 10625002Wang JJ, Ho ST, Tzeng JI, Tang CS. The effect of timing of dexamethasone administration on its efficacy as a prophylactic antiemetic for postoperative nausea and vomiting. Anesth Analg. 2000 Jul;91(1):136-9. doi: 10.1097/00000539-200007000-00025.
PubMed 10866900Liu K, Hsu CC, Chia YY. The effective dose of dexamethasone for antiemesis after major gynecological surgery. Anesth Analg. 1999 Nov;89(5):1316-8.
PubMed 10553859Kehlet H. Glucocorticoids for peri-operative analgesia: how far are we from general recommendations? Acta Anaesthesiol Scand. 2007 Oct;51(9):1133-5. doi: 10.1111/j.1399-6576.2007.01459.x. No abstract available.
PubMed 17850557Salerno A, Hermann R. Efficacy and safety of steroid use for postoperative pain relief. Update and review of the medical literature. J Bone Joint Surg Am. 2006 Jun;88(6):1361-72. doi: 10.2106/JBJS.D.03018.
PubMed 16757774Bisgaard T, Klarskov B, Kehlet H, Rosenberg J. Preoperative dexamethasone improves surgical outcome after laparoscopic cholecystectomy: a randomized double-blind placebo-controlled trial. Ann Surg. 2003 Nov;238(5):651-60. doi: 10.1097/01.sla.0000094390.82352.cb.
PubMed 14578725Romundstad L, Breivik H, Niemi G, Helle A, Stubhaug A. Methylprednisolone intravenously 1 day after surgery has sustained analgesic and opioid-sparing effects. Acta Anaesthesiol Scand. 2004 Nov;48(10):1223-31. doi: 10.1111/j.1399-6576.2004.00480.x.
PubMed 15504180Nagelschmidt M, Fu ZX, Saad S, Dimmeler S, Neugebauer E. Preoperative high dose methylprednisolone improves patients outcome after abdominal surgery. Eur J Surg. 1999 Oct;165(10):971-8. doi: 10.1080/110241599750008107.
PubMed 10574107Holte K, Kehlet H. Perioperative single-dose glucocorticoid administration: pathophysiologic effects and clinical implications. J Am Coll Surg. 2002 Nov;195(5):694-712. doi: 10.1016/s1072-7515(02)01491-6. No abstract available.
PubMed 12437261Sauerland S, Nagelschmidt M, Mallmann P, Neugebauer EA. Risks and benefits of preoperative high dose methylprednisolone in surgical patients: a systematic review. Drug Saf. 2000 Nov;23(5):449-61. doi: 10.2165/00002018-200023050-00007.
PubMed 11085349Mathiesen 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 19076108Celik C, Tasdemir N, Abali R, Bastu E, Akbaba E, Yucel SH, Gul A. The effect of uterine straightening by bladder distention before outpatient hysteroscopy: a randomised clinical trial. Eur J Obstet Gynecol Reprod Biol. 2014 Sep;180:89-92. doi: 10.1016/j.ejogrb.2014.06.029. Epub 2014 Jul 7.
PubMed 25058804
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01106547
- Acronym / sponsor ID
- Hysterektomistudiet
- Conditions
- Hysterectomy, Methylprednisolone, Postoperative Pain
- Keywords
- abdominal hysterectomy, glucocorticoids, rehabilitation, postoperative pain, analgetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Apr 2010 (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 the effect of 125 mg methylprednisolone, given intravenously 60-90 minutes before abdominal surgery,on the postoperative rehabilitation after abdominal hysterectomy.Sodium Chloride is the placebo. The following parameters are registered:
- Pain 3, 6 and 24 hours postoperatively and 2-7 days after surgery.
- The postoperative use of additional analgesics.
- Inflammatory parameters before and after surgery.
- Time until mobilization.
- Time until discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: Methylprednisolone 125mg |
| placebo/sodium chloride | Placebo comparator | Drug: Sodium Chloride 2 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients having an abdominal hysterectomy on a benign indication.
- Patients who speak and understand Danish.
- Patients who can give informed consent.
Key exclusion criteria (11 listed)
- Diabetics
- Regular use of glucocorticoids, opioids or tranquilizers
- Regular treatment with immunosuppressives
- Alcohol or drug abuse
- Morphine intolerance
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 |
|---|---|---|
| Methylprednisolone 125mgAlso: Solu-medrolSingle dose 60-90 minutes preoperatively | Drug | Methylprednisolone |
| Sodium Chloride 2 mlSingle dose 60-90 min preoperatively | Drug | placebo/sodium chloride |
Primary outcome
Pain 6 hours postoperatively
Time frame: 6 hours postoperatively
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 6 hours postoperatively
Pain 3 hours postoperatively
Time frame: 3 hours postoperatively
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 3 hours postoperatively
Pain 24 hours postoperatively
Time frame: 24 hours postoperatively
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 24 hours postoperatively
Pain
Time frame: 2-7 days postoperatively
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest once daily from 2nd-7th postoperative day
8 secondary outcomes
Use of additional analgesics
Time frame: 0-2 days
Postoperative nausea
Time frame: until 2 days postoperatively
Use of antiemetics
Time frame: 0-2 days postoperatively
Time until mobilization
Time frame: 0-2 days
Time until discharge after surgery
Time frame: 0-10 days
Inflammatory parameters
Time frame: 0-24 h preoperatively
Adverse effects
Time frame: 0-2 days
Inflammatory parameter
Time frame: 1-2 days postoperative
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 13 Oct 2011.
- BackgroundLidegaard O, Hammerum MS. Landspatientregisteret til kvalitetssikring i det gynækologiske speciale. 2002.
- BackgroundDanish hysterektomy database - year report 2004.
- Background: PubMed 11878721Hall GM, Peerbhoy D, Shenkin A, Parker CJ, Salmon P. Relationship of the functional recovery after hip arthroplasty to the neuroendocrine and inflammatory responses. Br J Anaesth. 2001 Oct;87(4):537-42. doi: 10.1093/bja/87.4.537.
- Background: PubMed 10625002Henzi I, Walder B, Tramer MR. Dexamethasone for the prevention of postoperative nausea and vomiting: a quantitative systematic review. Anesth Analg. 2000 Jan;90(1):186-94. doi: 10.1097/00000539-200001000-00038.
- Background: PubMed 10866900Wang JJ, Ho ST, Tzeng JI, Tang CS. The effect of timing of dexamethasone administration on its efficacy as a prophylactic antiemetic for postoperative nausea and vomiting. Anesth Analg. 2000 Jul;91(1):136-9. doi: 10.1097/00000539-200007000-00025.
- Background: PubMed 10553859Liu K, Hsu CC, Chia YY. The effective dose of dexamethasone for antiemesis after major gynecological surgery. Anesth Analg. 1999 Nov;89(5):1316-8.
- Background: PubMed 17850557Kehlet H. Glucocorticoids for peri-operative analgesia: how far are we from general recommendations? Acta Anaesthesiol Scand. 2007 Oct;51(9):1133-5. doi: 10.1111/j.1399-6576.2007.01459.x. No abstract available.
- Background: PubMed 16757774Salerno A, Hermann R. Efficacy and safety of steroid use for postoperative pain relief. Update and review of the medical literature. J Bone Joint Surg Am. 2006 Jun;88(6):1361-72. doi: 10.2106/JBJS.D.03018.
- Background: PubMed 14578725Bisgaard T, Klarskov B, Kehlet H, Rosenberg J. Preoperative dexamethasone improves surgical outcome after laparoscopic cholecystectomy: a randomized double-blind placebo-controlled trial. Ann Surg. 2003 Nov;238(5):651-60. doi: 10.1097/01.sla.0000094390.82352.cb.
- Background: PubMed 15504180Romundstad L, Breivik H, Niemi G, Helle A, Stubhaug A. Methylprednisolone intravenously 1 day after surgery has sustained analgesic and opioid-sparing effects. Acta Anaesthesiol Scand. 2004 Nov;48(10):1223-31. doi: 10.1111/j.1399-6576.2004.00480.x.
- Background: PubMed 10574107Nagelschmidt M, Fu ZX, Saad S, Dimmeler S, Neugebauer E. Preoperative high dose methylprednisolone improves patients outcome after abdominal surgery. Eur J Surg. 1999 Oct;165(10):971-8. doi: 10.1080/110241599750008107.
- Background: PubMed 12437261Holte K, Kehlet H. Perioperative single-dose glucocorticoid administration: pathophysiologic effects and clinical implications. J Am Coll Surg. 2002 Nov;195(5):694-712. doi: 10.1016/s1072-7515(02)01491-6. No abstract available.
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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.
Niels Jørgen Secher, Professor study chair
Department of Obstetrics, Hvidovre Hospital
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 Methylprednisolone 125mg and Sodium Chloride 2 ml in people with Hysterectomy and Methylprednisolone, run by Holbaek Sygehus 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 3 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: finished, as of the sponsor's last update on 13 Oct 2011. 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. 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 6 hours postoperatively (time frame: 6 hours postoperatively). The study lists 4 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 NCT01106547, which also lists 16 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 13 Oct 2011.