Postoperative PainPhase 3diclofenacNCT02752971
Wound Infiltration With Sodium Diclofenac vs Bupivacaine for Postoperative Pain Following Appendectomy
A Phase 3 study testing Bupivacaine and Sodium diclofenac in people with Postoperative Pain, run by Hospital Central Dr. Luis Ortega.
Trial summary
The infiltration of the surgical wound is an effective strategy for postoperative analgesia. Nonsteroidal antiinflammatories are useful in this way. Objective: To compare the analgesic effectiveness of diclofenac sodium, bupivacaine or bupivacaine plus diclofenac sodium infiltrating wound appendectomies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine and Sodium diclofenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Feb 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society Anesthesiologist I- II
- aged 18 and 65
- both sexes
- patients diagnosed with acute appendicitis operated under general anesthesia
Who cannot join
- Patients known to any allergy of the drugs used in the study
- Different incision approach Mc Burney
- Some intraoperative surgical complications
- Pregnant patients
About this study
Official title: Surgical Wound Infiltration With Sodium Diclofenac Versus Bupivacaine in the Treatment of Acute Postoperative Pain Following Appendectomy
The infiltration of the surgical wound is an effective strategy for postoperative analgesia. Nonsteroidal antiinflammatories are useful in this way.
Objective: To compare the analgesic effectiveness of diclofenac sodium, bupivacaine or bupivacaine plus diclofenac sodium infiltrating wound appendectomies.
Method: Comparative, double blind, American Society Anesthesiologist classification I-II,18-65años. Group 1 (Bupivacaine n = 14), Group 2 (Diclofenac Sodium n = 14), Group 3 (Bupivacaine + Diclofenac Sodium n = 15). Pain at rest and dynamic, rescue analgesic consumption in Post Anesthesia Care Unit (PACU) and 24 hours after surgery were evaluated.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine, Sodium diclofenac
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Sodium diclofenacDrug
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | A dilution of Bupivacaine 0,25% , 15 ml was infiltrated in surgical wound after close the aponeurosis Receives: Drug: Bupivacaine |
| Bupivacaine, sodium diclofenac | Experimental | A dilution of Bupivacaine 0,25% and sodium diclofenac 75 mgr, was infiltrated in surgical wound after close the aponeurosis Receives: Drug: Bupivacaine; Drug: Sodium diclofenac |
| Sodium diclofenac | Experimental | A dilution of sodium diclofenac 75 mgrs (3ml) and 12 ml of solution 0,9% was infiltrated in surgical wound after close the aponeurosis Receives: Drug: Sodium diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
rest and dynamic postoperative pain with visual analogue scale
Measured: 24 hours of postoperative period
rescue analgesic consumption
Measured: 24 hours of postoperative period
appearance of bowel sounds
auscultation of bowel sounds
Measured: 24 hours of postoperative period
changes in rest and dynamic postoperative pain with visual analogue scale
Measured: 24 hours of postoperative pain
Secondary outcomes (1)
number of participants with skin suture removal after 10 days
Measured: 10 days of postoperative pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Central Dr. Luis Ortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Arismendi Gómez, Hospital Central Dr. Luis Ortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752971
- Sponsor's protocol ID
- Sodium Diclofenac in wounds
- Acronym
- diclofenac
- Status last verified
- Apr 2016
- First submitted
- 20 Mar 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Wound Infiltration With Sodium Diclofenac Versus Bupivacaine in the Treatment of Acute Postoperative Pain Following Appendectomy
- ClinicalTrials.gov ID
- NCT02752971
- Acronym / sponsor ID
- diclofenac / Sodium Diclofenac in wounds
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospital Central Dr. Luis OrtegaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The infiltration of the surgical wound is an effective strategy for postoperative analgesia. Nonsteroidal antiinflammatories are useful in this way.
Objective: To compare the analgesic effectiveness of diclofenac sodium, bupivacaine or bupivacaine plus diclofenac sodium infiltrating wound appendectomies.
Method: Comparative, double blind, American Society Anesthesiologist classification I-II,18-65años. Group 1 (Bupivacaine n = 14), Group 2 (Diclofenac Sodium n = 14), Group 3 (Bupivacaine + Diclofenac Sodium n = 15). Pain at rest and dynamic, rescue analgesic consumption in Post Anesthesia Care Unit (PACU) and 24 hours after surgery were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Drug: BupivacaineA dilution of Bupivacaine 0,25% , 15 ml was infiltrated in surgical wound after close the aponeurosis |
| Bupivacaine, sodium diclofenac | Experimental | Drug: Bupivacaine, Drug: Sodium diclofenacA dilution of Bupivacaine 0,25% and sodium diclofenac 75 mgr, was infiltrated in surgical wound after close the aponeurosis |
| Sodium diclofenac | Experimental | Drug: Sodium diclofenacA dilution of sodium diclofenac 75 mgrs (3ml) and 12 ml of solution 0,9% was infiltrated in surgical wound after close the aponeurosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society Anesthesiologist I- II
- aged 18 and 65
- both sexes
- patients diagnosed with acute appendicitis operated under general anesthesia
Key exclusion criteria (4 listed)
- Patients known to any allergy of the drugs used in the study
- Different incision approach Mc Burney
- Some intraoperative surgical complications
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine | Drug | Bupivacaine, Bupivacaine, sodium diclofenac |
| Sodium diclofenac | Drug | Bupivacaine, sodium diclofenac, Sodium diclofenac |
Primary outcome
rest and dynamic postoperative pain with visual analogue scale
Time frame: 24 hours of postoperative period
rescue analgesic consumption
Time frame: 24 hours of postoperative period
appearance of bowel sounds
Time frame: 24 hours of postoperative period
auscultation of bowel sounds
changes in rest and dynamic postoperative pain with visual analogue scale
Time frame: 24 hours of postoperative pain
1 secondary outcome
number of participants with skin suture removal after 10 days
Time frame: 10 days of postoperative pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine and Sodium diclofenac in people with Postoperative Pain, run by Hospital Central Dr. Luis Ortega.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rest and dynamic postoperative pain with visual analogue scale (time frame: 24 hours of postoperative period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.