ISRCTN - ISRCTN48329522: Perioperative Duloxetine and Etoricoxib improve postoperative pain

Plain English Summary

Background and study aims
Having spinal surgery requires a lot of recovery time. Usually patients who undergo surgery need medication to help them recover and control any after surgery pain. There are a variety of medications that can be used to help treat patients. Some suggestions for medications to use include duloxetine (which is used to treat anxiety, depression, neurological pain) as well as etoricoxib (an anti-inflammatory (swelling) painkiller). It can be sometimes difficult for healthcare workers to figure out what the best combination of medications is most effective and provides patients with the least amount of side effects while still improving their pain symptoms. The aim of this study is to find the best regimen of drugs for the postoperative (after surgery) analgesia (pain prevention) for patients undergoing spinal surgeries in order to improve patient satisfaction of their postoperative care and to provide them with less side effects from medication after the surgery.

Who can participate?
Adults patients aged 18 and older who are having spinal surgery.

What does the study involve?
Participants are randomly allocated to one of four groups. Those in the first group receive a capsule containing a placebo (dummy drug) and two placebo tablets an hour before surgery and then again 24 hours later. Those in the second group receive a capsule a placebo and two etoricoxib tablets an hour before surgery and then again 24 hours later. Those in the first group receive a capsule containing duloxetine and two placebo tablets an hour before surgery and then again 24 hours later. Those in the fourth group receive a capsule containing duloxetine and two etoricoxib tablets an hour before surgery and then again 24 hours later. Patients then have their surgery as per standard practice. Half an hour after their anaesthesia has worn off and then two, four, six, 12, 24 and 48 hours later, participants are asked to rate their pain levels. Their satisfaction with the treatment they received and pain killer use is also recorded.

What are the possible benefits and risks of participating?
Participants may benefit from being more satisfied with their surgery and less side effects from drugs after the surgery. There are no notable risks with participating however there are risks with any medication and this should be monitored.

Where is the study run from?
Minia University Hospital (Egypt)

When is the study starting and how long is it expected to run for?
April 2015 to May 2017

Who is funding the study?
Investigator initiated and funded (Egypt)

Who is the main contact?
Mr Josef Zekry Attia

Trial website

Contact information

Type

Scientific

Primary contact

Mr Josef Zekry Attia

ORCID ID

http://orcid.org/0000-0003-4842-231X

Contact details

Faculty of Medicine
Al-Minia University
Main Road
Shalaby Land - Menia
Al-Minia
61111
Egypt
+20 10 00 427407
josefzekry2@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7

Study information

Scientific title

Perioperative Duloxetine and Etoricoxib to improve postoperative pain after lumbar laminectomy: A randomized, double-blind, controlled study

Acronym

Study hypothesis

Perioperative Duloxetine and Etoricoxib given together are more effective than when given individually at reducing postoperative pain after lumbar laminectomy.

Ethics approval

Institutional Ethics Committee at Faculty of Medicine Minia university, 01/05/2015, ref: 1-5-2015

Study design

Four-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Postoperative pain after laminectomy surguries

Intervention

Patients admitted to the hospital are randomised using computer-generated random numbers with closed-sealed envelopes into one of the four groups of 30 patients.

Group 1: Participants receive a placebo capsule + two placebo tablets one hour before surgery and again 24 hours later
Group 2: Participants receive a placebo capsule + 90 mg etoricoxib tablets one hour before surgery and again 24 hours later
Group 3: Participants receive a 60 mg duloxetine capsule + two placebo tablets one hour before surgery and again 24 hours later
Group 4: Participants receive a 60 mg duloxetine capsule + two 90 mg etoricoxib tablets one hour before surgery and again 24 hours later

Participants in all groups undergo surgery as per standard practice.

Participants in all groups are asked to rate their pain levels 30 minutes after the end of anesthesia and two, four, six, 12, 24 and 48 hours post-operatively. In addition, patient satisfaction and pain killer use is also assessed 24 and 48 hours after surgery.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Pain is measured using pain assessment measures and questions 30 minutes after the end of anesthesia and two, four, six, 12, 24 and 48 hours post-operatively

Secondary outcome measures

1. The time to first rescue analgesic is routinely 24h and 48h postoperatively
2. Total morphine consumption is measured by calculating the doses at 24 and 48 hours post-operatively
3. Side effects, including headache, rash, nausea, vomiting, dizziness and drowsiness are recorded. The severity of postoperative nausea and vomiting (PONV) is graded on a four-point ordinal scale
4. Patient satisfaction is measured using a numerical rating scale (NRS) at 24 hours post-operatively

Overall trial start date

01/04/2015

Overall trial end date

01/05/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients with an ASA physical status of I, II and III scheduled for single level lumbar spinal disc prolapsed surgery
2. Can provide written informed consent
3. Aged between 18 and older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

131 consecutive patients who met the inclusion criteria were allocated for the study . Eleven patients refused to participate. Therefore, 120 patients were randomized and included in the study. Characteristics of patients and surgical procedures for each group

Total final enrolment

120

Participant exclusion criteria

1. History of allergic reaction to any of the study drugs
2. History of drug or alcohol abuse
3. Abnormal renal or liver function tests.
4. Patients using antidepressants who did not stop taking them two weeks before surgery
5. Patients with previous cervical surgeries, psychiatric disorders and patients receiving opioid analgesic medications within 24 hours preoperatively

Recruitment start date

01/05/2015

Recruitment end date

01/04/2017

Locations

Countries of recruitment

Egypt

Trial participating centre

Minia University Hospital
Corniche El Nil El Corniche El Menia Menia Governorate
Minia
61111
Egypt

Sponsor information

Organisation

Al-Minia University

Sponsor type

University/education

Website

http://www.minia.edu.eg/med/

Funders

Funder type