The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy

Postoperative Pain Clinical Trial

Official title:

The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106547
• Other study ID #: Hysterektomistudiet
• Secondary ID: SJ-1272010-01844
• Status: Completed
• Phase: Phase 4
• First received: April 14, 2010
• Last updated: October 12, 2011
• Start date: August 2009
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Holbaek Sygehus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines AgencyDenmark: The GCP unit at Copenhagen University
• Study type: Interventional

Clinical 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. Pain 3, 6 and 24 hours postoperatively and 2-7 days after surgery.

2. The postoperative use of additional analgesics.

3. Inflammatory parameters before and after surgery.

4. Time until mobilization.

5. Time until discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients having an abdominal hysterectomy on a benign indication.

• Patients who speak and understand Danish.

• Patients who can give informed consent.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hysterectomy
• Methylprednisolone
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Methylprednisolone 125mg
Single dose 60-90 minutes preoperatively
• Sodium Chloride 2 ml
Single dose 60-90 min preoperatively

Locations

Country	Name	City	State
Denmark	Department of Gynaechology and Obstetrics, Holbæk Sygehus	Holbæk

Sponsors (1)

Lead Sponsor	Collaborator
Holbaek Sygehus

Country where clinical trial is conducted

Denmark, 

References & Publications (14)

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. — View Citation

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. — View Citation

Henzi I, Walder B, Tramèr MR. Dexamethasone for the prevention of postoperative nausea and vomiting: a quantitative systematic review. Anesth Analg. 2000 Jan;90(1):186-94. — View Citation

Holte K, Kehlet H. Perioperative single-dose glucocorticoid administration: pathophysiologic effects and clinical implications. J Am Coll Surg. 2002 Nov;195(5):694-712. Review. — View Citation

Kehlet H. Glucocorticoids for peri-operative analgesia: how far are we from general recommendations? Acta Anaesthesiol Scand. 2007 Oct;51(9):1133-5. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Use of additional analgesics	The use of other analgesics than paracetamol and diclofenac postoperatively - dosage.	0-2 days	No
Secondary	Postoperative nausea	Numbers of vomits	until 2 days postoperatively	No
Secondary	Use of antiemetics	Dosage of antiemetics during the first 2 days postoperatively	0-2 days postoperatively	No
Secondary	Time until mobilization		0-2 days	No
Secondary	Time until discharge after surgery		0-10 days	No
Secondary	Inflammatory parameters	CRP measured 0-24 hours preoperatively before injection of project medicine.	0-24 h preoperatively	No
Secondary	Adverse effects		0-2 days	No
Secondary	Inflammatory parameter	CRP measured at 10am on the first and second postoperative day.	1-2 days postoperative	No