NCT01106547

Brief 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. 1.Pain 3, 6 and 24 hours postoperatively and 2-7 days after surgery.
  2. 2.The postoperative use of additional analgesics.
  3. 3.Inflammatory parameters before and after surgery.
  4. 4.Time until mobilization.
  5. 5.Time until discharge.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

Enrollment Period

2.1 years

First QC Date

April 14, 2010

Last Update Submit

October 12, 2011

Conditions

HysterectomyMethylprednisolonePostoperative Pain

Keywords

abdominal hysterectomyglucocorticoidsrehabilitationpostoperative painanalgetics

Outcome Measures

Primary Outcomes (4)

  • Pain 6 hours postoperatively

    Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 6 hours postoperatively

    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

    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

    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

    2-7 days postoperatively

Secondary Outcomes (8)

  • Use of additional analgesics

    0-2 days

  • Postoperative nausea

    until 2 days postoperatively

  • Use of antiemetics

    0-2 days postoperatively

  • Time until mobilization

    0-2 days

  • Time until discharge after surgery

    0-10 days

  • +3 more secondary outcomes

Study Arms (2)

Methylprednisolone

EXPERIMENTAL
Drug: Methylprednisolone 125mg

placebo/sodium chloride

PLACEBO COMPARATOR
Drug: Sodium Chloride 2 ml

Interventions

Methylprednisolone 125mgDRUG

Single dose 60-90 minutes preoperatively

Also known as: Solu-medrol
Methylprednisolone
Sodium Chloride 2 mlDRUG

Single dose 60-90 min preoperatively

placebo/sodium chloride

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having an abdominal hysterectomy on a benign indication.
  • Patients who speak and understand Danish.
  • Patients who can give informed consent.

You may not qualify if:

  • Diabetics
  • Regular use of glucocorticoids, opioids or tranquilizers
  • Regular treatment with immunosuppressives
  • Alcohol or drug abuse
  • Morphine intolerance
  • Age under 18
  • Chronic pain disease eg fibromyalgia, rheumatoid arthritis
  • Malign indication for hysterectomy
  • BMI over 35
  • Decreased kidney function
  • ASA III or IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynaechology and Obstetrics, Holbæk Sygehus

Holbæk, 4300, Denmark

Location

Related Publications (16)

  • Lidegaard O, Hammerum MS. Landspatientregisteret til kvalitetssikring i det gynækologiske speciale. 2002.

    BACKGROUND

  • Danish hysterektomy database - year report 2004.

    BACKGROUND

  • 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.

    PMID: 11878721BACKGROUND

  • Henzi 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.

    PMID: 10625002BACKGROUND

  • Wang 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.

    PMID: 10866900BACKGROUND

  • Liu K, Hsu CC, Chia YY. The effective dose of dexamethasone for antiemesis after major gynecological surgery. Anesth Analg. 1999 Nov;89(5):1316-8.

    PMID: 10553859BACKGROUND

  • Kehlet 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.

    PMID: 17850557BACKGROUND

  • Salerno 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.

    PMID: 16757774BACKGROUND

  • Bisgaard 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.

    PMID: 14578725BACKGROUND

  • Romundstad 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.

    PMID: 15504180BACKGROUND

  • Nagelschmidt 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.

    PMID: 10574107BACKGROUND

  • Holte 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.

    PMID: 12437261BACKGROUND

  • Sauerland 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.

    PMID: 11085349BACKGROUND

  • Mathiesen 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.

    PMID: 19076108BACKGROUND

  • Celik 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.

    PMID: 25058804DERIVED

  • Aabakke AJ, Holst LB, Jorgensen JC, Secher NJ. The effect of a preoperative single-dose methylprednisolone on postoperative pain after abdominal hysterectomy: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014 Sep;180:83-8. doi: 10.1016/j.ejogrb.2014.06.026. Epub 2014 Jul 7.

    PMID: 25058803DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

MethylprednisoloneMethylprednisolone HemisuccinateSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Niels Jørgen Secher, Professor

    Department of Obstetrics, Hvidovre Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anna Aabakke, M.D.

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 20, 2010

Study Start

August 1, 2009

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

October 13, 2011

Record last verified: 2011-10

Locations

DK(1)