The Effect of Anti-Inflammatory Analgesics on Pain Following Hallux Valgus Surgery

Condition(s) targeted: Postoperative Pain

Intervention: etoricoxib (Drug); tramadol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Karolinska Institutet

Official(s) and/or principal investigator(s):
Jan Jakobsson, MD, PhD,, Principal Investigator, Affiliation: Foot & Ancle Surgical Center

The effects of NSAIDs and Coxibs on the formation of bone and fracture healing have been a matter of debate since long 1,2.

There is, however, limited data in humans and further prospective randomised studies are warranted. Rueben and Ekman studied in a prospective randomised double blind study the effects of celecoxib, a selective cox-II-inhibitor, on pain and bone healing following spine surgery. They found significant effects on reduction of pain and need for opioid analgesics postoperatively but could see no negative effects the numbers of "none-unions" at a 1-year follow up 3.

In a similar prospective randomised double-blind study design significant effects in reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the perioperative multi-modal pain strategy for cruciate-ligament reconstruction and no negative effects could bee seen on six month follow-up of the strength of the reconstructed ligament 4,5.

The aim of the present study is to further study the effects of the perioperative use of etoricoxibe, a selective cox-II-inhibitor, in a prospective randomised double-blind study on bone healing, pain and need for rescue analgesia in patients undergoing elective Hallux Valgus surgery with a standardised surgical technique ad modum Turan.

Study population 90 ASA physiological status1-2 patients scheduled for elective HV surgery

The patients are going to be randomised into 2 groups, 45 patients in each;

1. etoricoxib 90 mg once daily x 5

2. tramadol 100 mg twice daily x 5

First line rescue medication t. paracetamol 1 gr up to 4 gram daily Second line rescue t. oxicodone 10 mg

Primary study variables:

- X-ray evaluation (CT-investigation) of bone healing assessed according to Sophiahemmet

at eight and twelve weeks after surgery

- Number of patients requiring rescue medication

- Patient assessment using "brief pain inventory" 24 hours and 2 weeks after surgery

Secondary study variables are;

- VAS grading Day 1-7

- Compliance to base medication

- Need for rescue analgesia Day 1-7

- Adverse Effects

- Experience of any emetic symptoms

- Experience of any gastrointestinal symptoms

- Satisfaction with pain medication Day 20

- Wound dressing Day 20

- Clinical evaluation 17 weeks, final assessment

Official title: The Effect of Anti-Inflammatory Analgesics on Bone Repair, Pain and Gastro-Intestinal Side Effects After Hallux Valgus Surgery; a Prospective Randomised Double-Blind Placebo Controlled Study.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Single Group Assignment, Efficacy Study

Primary outcome:

Number of patients requiring rescue medication

Patient assessment using "brief pain inventory" 24 hours and 2 weeks after surgery

Secondary outcome:

VAS grading Day 1-7

Compliance to base medication

Experience of any emetic symptoms

Experience of any gastrointestinal symptoms

Satisfaction with pain medication Day 20

Wound dressing Day 20

Clinical evaluation 17 weeks, final assessment

Detailed description: See brief summary

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Health ASA 1-2 patients 18-65 years of age

Exclusion Criteria:

- ASA/NSAID allergy

- Renal disease

- Litium therapy

- Complicated cardiovascular disease

Foot & Ancle Surgical Center, Stockholm 11542, Sweden; Recruiting
Jan Jakobsson, MD, PhD,, Phone: 46702500960, Email: jan.jakobsson@ki.se
Jan Jakobsson, MD, PhD,, Principal Investigator

Starting date: October 2008
Ending date: August 2009
Last updated: January 28, 2009