Perioperative Duloxetine and Etoricoxib improve postoperative pain
| ISRCTN | ISRCTN48329522 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48329522 |
| Secondary identifying numbers | 7 |
- Submission date
- 17/06/2017
- Registration date
- 19/06/2017
- Last edited
- 26/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Faculty of Medicine
Al-Minia University
Main Road
Shalaby Land - Menia
Al-Minia
61111
Egypt
 ORCID ID |
0000-0003-4842-231X |
|---|---|
| Phone | +20 10 00 427407 |
| josefzekry2@yahoo.com |
Study information
| Study design | Four-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Perioperative Duloxetine and Etoricoxib to improve postoperative pain after lumbar laminectomy: A randomized, double-blind, controlled study |
| Study objectives | Perioperative Duloxetine and Etoricoxib given together are more effective than when given individually at reducing postoperative pain after lumbar laminectomy. |
| Ethics approval(s) | Institutional Ethics Committee at Faculty of Medicine Minia university, 01/05/2015, ref: 1-5-2015 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2015 |
| Completion date | 01/05/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2015 |
| Date of final enrolment | 01/04/2017 |
Locations
Countries of recruitment
- Egypt
Study participating centre
El Corniche El Menia
Menia Governorate
Minia
61111
Egypt
Sponsor information
University/education
Faculty of Medicine
Main Road
Shalaby Land - Menia
Al-Minia
61111
Egypt
| Phone | +20 86 23 42584 |
|---|---|
| dean.med@mu.edu.eg | |
| Website | http://www.minia.edu.eg/med/ |
"ROR" |
https://ror.org/02hcv4z63 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication of the research is planned to be after registering the clinical trial as soon as possible. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from josefzekry2@yahoo.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/12/2017 | 26/11/2020 | Yes | No |
Editorial Notes
26/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
