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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Mr Josef Zekry Attia
Scientific

Faculty of Medicine
Al-Minia University
Main Road
Shalaby Land - Menia
Al-Minia
61111
Egypt

ORCiD logoORCID ID 0000-0003-4842-231X
Phone +20 10 00 427407
Email josefzekry2@yahoo.com

Study information

Study designFour-arm randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titlePerioperative Duloxetine and Etoricoxib to improve postoperative pain after lumbar laminectomy: A randomized, double-blind, controlled study
Study objectivesPerioperative 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) studiedPostoperative pain after laminectomy surguries
InterventionPatients 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 typeOther
Primary outcome measurePain 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 measures1. 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 date01/04/2015
Completion date01/05/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants131 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 enrolment120
Key inclusion criteria1. 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 criteria1. 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 enrolment01/05/2015
Date of final enrolment01/04/2017

Locations

Countries of recruitment

  • Egypt

Study participating centre

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

Sponsor information

Al-Minia University
University/education

Faculty of Medicine
Main Road
Shalaby Land - Menia
Al-Minia
61111
Egypt

Phone +20 86 23 42584
Email dean.med@mu.edu.eg
Website http://www.minia.edu.eg/med/
ROR logo "ROR" https://ror.org/02hcv4z63

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/06/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPublication of the research is planned to be after registering the clinical trial as soon as possible.
IPD sharing planThe 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.