Knee Arthroscopic SurgeryNCT03847792
Analgesic Effect Of Intra-articular Bupivacaine Fentanyl for Postoperative Pain Relief in Knee Arthroscopic Surgery
A study testing Group DB/Dexamethasone-Bupivacaine and Group FB /Fentanyl-Bupivacaine in people with Knee Arthroscopic Surgery, run by Mansoura University at 2 sites in Egypt.
Trial summary
However, local anesthetic agents can produce analgesia for a limited time when used as a single injection. Bupivacaine is a local anesthetic that has an immediate action on pain by blocking peripheral afferents. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroscopic Surgery
- What is being tested?
- Group DB/Dexamethasone-Bupivacaine and Group FB /Fentanyl-Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 2 sitesEgypt
- Study dates
- 31 Mar 2019to 30 Jun 2020
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status (ASA) I or II
Who cannot join
- Contraindication to spinal anesthesia.
- Allergy to the study drugs.
- Refusal of the patients.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mohamed A Sultan
Al Mansurah, DK, 050
Mansoura University
Al Mansurah, Eastern, 050
About this study
Official title: Analgesic Effect Of Intra-articular Dexamethasone Versus Fentanyl Added as an Adjuvant to Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery
However, local anesthetic agents can produce analgesia for a limited time when used as a single injection. Bupivacaine is a local anesthetic that has an immediate action on pain by blocking peripheral afferents. However, as the ideal analgesic, the drug must cover the whole postoperative period (≥ 24 hours); therefore, bupivacaine is usually combined with many adjutants to provide long-lasting post-arthroscopy analgesia.
Read the detailed description
Intr-articular drug administration has gained popularity because of its simplicity and efficacy in achieving anesthesia for diagnostic and operative arthroscopy and for providing postoperative analgesia .although the knee joint has been examined most commonly, arthroscopy of other joints such as shoulder, ankle, wrist, metatarsophalangeal and temporomandibular joints is being increasingly used.
Intra-articular installation of local anesthesia during arthroscopic procedures has been used by many orthopedic surgeons to provide pain relief after surgery.The aim of this study was to evaluate the analgesic efficacy of intra-articular dexamethasone versus fentanyl added as an adjuvant to bupivacaine in patients undergoing knee arthroscopic surgery
- Conditions
- Knee Arthroscopic Surgery
- Being tested
- Group DB/Dexamethasone-Bupivacaine, Group FB /Fentanyl-Bupivacaine, Group PB/Placebo-Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group DB/Dexamethasone-BupivacaineDrug
The patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone.
Group FB /Fentanyl-BupivacaineDrug
The patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine.
Group PB/Placebo-BupivacaineDrug
Patients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Group DB/Dexamethasone-Bupivacaine | Active comparator | Patients were received an intra-articular injection of 8mg dexamethasone added to18mL of 0.25% bupivacaine Receives: Drug: Group DB/Dexamethasone-Bupivacaine |
| Group FB /Fentanyl-Bupivacaine | Active comparator | Patients were received an intra-articular injection of 1 ug/kg fentanyl added to 18 mL of 0.25% bupivacaine Receives: Drug: Group FB /Fentanyl-Bupivacaine |
| Group PB/Placebo-Bupivacaine | Placebo comparator | Patients were received an intra-articular injection of 2 mL isotonic saline added to 18 mL of 0.25% bupivacaine Receives: Drug: Group PB/Placebo-Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative analgesia
Time to the first request of pethidine in minutes within the first 24 hours postoperatively
Measured: for 24 hour after surgery
Secondary outcomes (5)
Total analgesic requirement
Total analgesic requirement of pethidine will be recorded during the first 24 hours following surgery
Measured: for 24 hour after surgery
Mean arterial blood pressure
Mean arterial blood pressure measured in mm Hg and assessed at 1,2,4,6,8,12,18 and 24 hours following the discharge of the patient from the operating theatre.
Measured: At 1,2,4,6,8,12,18 and 24 hours postoperatively.
Heart rate
Heart rate will be measured in beats/minute and assessed at 1,2,4,6,8,12,18 and 24 hours following the discharge of the patient from the operating theatre.
Measured: At 1,2,4,6,8,12,18 and 24 hours postoperatively.
Pain score
Measured with visual analogue score(VAS):0=no pain and 100=worst imaginable pain measured at 1,2,4,6,8,12,18 and 24 hours
Measured: measured at 1,2,4,6,8,12,18 and 24 hours postoperatively.
Patients' satisfaction
satisfaction score from 1 to 4; as 4=Excellent ,3=good ,2=satisfactory and 1=poor will be measured after 24 hours.
Measured: for 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start31 Mar 2019
- Primary completion30 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed M Sultan, MD, Study chair, Professor of Anaesthesia and Surgical Intensive CareHazem ESM Weheba, MD, Study director, Assistant Professor of Anaesthesia and Surgical Intensive CareHosam Ibrahim EL said saber, MD, Study director, Lecturer of Anaesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847792
- Sponsor's protocol ID
- MS/18.09.306
- Status last verified
- Sep 2020
- First submitted
- 19 Feb 2019
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect Of Intra-articular Dexamethasone Versus Fentanyl Added as an Adjuvant to Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery
- ClinicalTrials.gov ID
- NCT03847792
- Acronym / sponsor ID
- MS/18.09.306
- Conditions
- Knee Arthroscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 31 Mar 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 20 Feb 2019 (actual)
- 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.
However, local anesthetic agents can produce analgesia for a limited time when used as a single injection. Bupivacaine is a local anesthetic that has an immediate action on pain by blocking peripheral afferents. However, as the ideal analgesic, the drug must cover the whole postoperative period (≥ 24 hours); therefore, bupivacaine is usually combined with many adjutants to provide long-lasting post-arthroscopy analgesia.
Detailed description
Intr-articular drug administration has gained popularity because of its simplicity and efficacy in achieving anesthesia for diagnostic and operative arthroscopy and for providing postoperative analgesia .although the knee joint has been examined most commonly, arthroscopy of other joints such as shoulder, ankle, wrist, metatarsophalangeal and temporomandibular joints is being increasingly used.
Intra-articular installation of local anesthesia during arthroscopic procedures has been used by many orthopedic surgeons to provide pain relief after surgery.The aim of this study was to evaluate the analgesic efficacy of intra-articular dexamethasone versus fentanyl added as an adjuvant to bupivacaine in patients undergoing knee arthroscopic surgery
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group DB/Dexamethasone-Bupivacaine | Active comparator | Drug: Group DB/Dexamethasone-BupivacainePatients were received an intra-articular injection of 8mg dexamethasone added to18mL of 0.25% bupivacaine |
| Group FB /Fentanyl-Bupivacaine | Active comparator | Drug: Group FB /Fentanyl-BupivacainePatients were received an intra-articular injection of 1 ug/kg fentanyl added to 18 mL of 0.25% bupivacaine |
| Group PB/Placebo-Bupivacaine | Placebo comparator | Drug: Group PB/Placebo-BupivacainePatients were received an intra-articular injection of 2 mL isotonic saline added to 18 mL of 0.25% bupivacaine |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status (ASA) I or II
Key exclusion criteria (3 listed)
- Contraindication to spinal anesthesia.
- Allergy to the study drugs.
- Refusal of the 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 |
|---|---|---|
| Group DB/Dexamethasone-BupivacaineThe patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone. | Drug | Group DB/Dexamethasone-Bupivacaine |
| Group FB /Fentanyl-BupivacaineThe patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine. | Drug | Group FB /Fentanyl-Bupivacaine |
| Group PB/Placebo-BupivacainePatients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine. | Drug | Group PB/Placebo-Bupivacaine |
Primary outcome
Duration of postoperative analgesia
Time frame: for 24 hour after surgery
Time to the first request of pethidine in minutes within the first 24 hours postoperatively
5 secondary outcomes
Total analgesic requirement
Time frame: for 24 hour after surgery
Mean arterial blood pressure
Time frame: At 1,2,4,6,8,12,18 and 24 hours postoperatively.
Heart rate
Time frame: At 1,2,4,6,8,12,18 and 24 hours postoperatively.
Pain score
Time frame: measured at 1,2,4,6,8,12,18 and 24 hours postoperatively.
Patients' satisfaction
Time frame: for 24 hour after surgery
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 11 Sep 2020.
- Individual participant dataSharing planned: Yes. Following publication
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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.
Mohamed M Sultan, MD study chair
Professor of Anaesthesia and Surgical Intensive Care
Hazem ESM Weheba, MD study director
Assistant Professor of Anaesthesia and Surgical Intensive Care
Hosam Ibrahim EL said saber, MD study director
Lecturer of Anaesthesia and Surgical Intensive Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group DB/Dexamethasone-Bupivacaine and Group FB /Fentanyl-Bupivacaine in people with Knee Arthroscopic Surgery, run by Mansoura University at 2 sites in Egypt.
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 1 inclusion and 3 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 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Duration of postoperative analgesia (time frame: for 24 hour after surgery). 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 11 Sep 2020.