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

Condition(s) targeted: Hysterectomy; Methylprednisolone; Postoperative Pain

Intervention: Methylprednisolone 125mg (Drug); Sodium Chloride 2 ml (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Holbaek Sygehus

Official(s) and/or principal investigator(s):
Niels Jørgen Secher, Professor, Study Chair, Affiliation: Department of Obstetrics, Hvidovre Hospital

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.

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

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

Primary outcome:

Pain 6 hours postoperatively

Pain 3 hours postoperatively

Pain 24 hours postoperatively

Pain

Secondary outcome:

Use of additional analgesics

Postoperative nausea

Use of antiemetics

Time until mobilization

Time until discharge after surgery

Inflammatory parameters

Adverse effects

Inflammatory parameter

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Department of Gynaechology and Obstetrics, Holbæk Sygehus, Holbæk 4300, Denmark

Related 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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

Starting date: August 2009
Last updated: October 12, 2011