Postoperative AnalgesiaNCT03239314
Analgesic Effect of Adductor Canal Block With and Without Dexamethasone for Knee Arthroscopy
A study testing Saline Solution and Dexamethasone in people with Postoperative Analgesia, run by Assiut University.
Trial summary
The purpose of this study was to evaluate the efficacy of ultra-sound guided adductor canal block with and without dexamethasone when added to bupivacaine on the duration of postoperative analgesia in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery using Numeric Rating Score (NRS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Saline Solution and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to 22 Jul 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ASA I-II Arthroscopic anterior cruciate ligament reconstruction
Who cannot join
- patient refusal
- drug allergy
- failed procedure
About this study
Official title: The Effect of Adding Dexamethasone to Bupivacaine in Ultrasound Guided Adductor Canal Block for Postoperative Analgesia Following Knee Arthroscopic Anterior Cruciate Ligament Reconstruction
The purpose of this study was to evaluate the efficacy of ultra-sound guided adductor canal block with and without dexamethasone when added to bupivacaine on the duration of postoperative analgesia in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery using Numeric Rating Score (NRS).
Read the detailed description
Adductor canal block was done by Ultra-sound. After confirmation of the block and exclusion of any signs of toxicity or nerve injury, the patients operations were done under spinal anesthesia. Patients were allocated into one of 2 groups (30 patients per group).
- Group I: the patients received a single-shot of 20 ml plain bupivacaine (0.5%) +2 ml normal saline. ii.Group II: the patients received 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml).
Postoperative pain were assessed by Numeric Rating Scale (N.R.S) every 6 h post-operatively for 24 h.
Whenever, the NRS Score was ≥4 or the patient requested pain medication, analgesia was provided by ketorolac 30 mg amp IV, then morphine 1mg ̸ kg slowly IV as a rescue analgesia. Time to first request for analgesia \& total dose of rescue analgesia were be recorded.
- Satisfaction score will be measured on a linear numerical scale; ranging from 0 = complete dissatisfaction to 10 = complete satisfaction. Any post-operative side effects, like nausea, vomiting, bradycardia, hypotension will be also documented. The time to first analgesic requirement will be recorded, and the cumulative, post-operative opioid consumption in 24 h post-operatively will be recorded. Assessment of Quadriceps Strength at preoperative, 6, 12, 18, and 24 h postoperative from zero to 5.
- Conditions
- Postoperative Analgesia
- Being tested
- Saline Solution, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline SolutionDrug
Also called Normal Saline Solution
Injected in the adductor canal
DexamethasoneDrug
Also called Decadron
Injected in the adductor canal
| Study group | Role | What they receive |
|---|---|---|
| group I | Active comparator | Group I (MS): received single shot 20 ml 0.5% isobaric bupivacaine + 2.0 ml normal saline solution injected into the adductor canal preoperatively. Receives: Drug: Saline Solution |
| group II | Active comparator | Group II (MD): received 20 ml 0.5% isobaric bupivacaine + 8.0 mg dexamethasone (2.0 ml) injected into adductor canal preoperatively. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of postoperative analgesia
assessed by pain score
Measured: One day postoperative
Secondary outcomes (1)
postoperative analgesic consumption
postoperative opioid consumption
Measured: One day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study startOct 2016
- Primary completionJun 2017
- Study completion22 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed galal aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239314
- Sponsor's protocol ID
- 17100210
- Status last verified
- Aug 2017
- First submitted
- 24 Jul 2017
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rasouli MR, Viscusi ER. Adductor Canal Block for Knee Surgeries: An Emerging Analgesic Technique. Arch Bone Jt Surg. 2017 May;5(3):131-132. No abstract available.
PubMed 28656158Ibrahim AS, Aly MG, Farrag WS, Gad El-Rab NA, Said HG, Saad AH. Ultrasound-guided adductor canal block after arthroscopic anterior cruciate ligament reconstruction: Effect of adding dexamethasone to bupivacaine, a randomized controlled trial. Eur J Pain. 2019 Jan;23(1):135-141. doi: 10.1002/ejp.1292. Epub 2018 Aug 6.
PubMed 30066465
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Dexamethasone to Bupivacaine in Ultrasound Guided Adductor Canal Block for Postoperative Analgesia Following Knee Arthroscopic Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT03239314
- Acronym / sponsor ID
- 17100210
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 22 Jul 2017 (actual)
- First posted
- 4 Aug 2017 (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.
The purpose of this study was to evaluate the efficacy of ultra-sound guided adductor canal block with and without dexamethasone when added to bupivacaine on the duration of postoperative analgesia in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery using Numeric Rating Score (NRS).
Detailed description
Adductor canal block was done by Ultra-sound. After confirmation of the block and exclusion of any signs of toxicity or nerve injury, the patients operations were done under spinal anesthesia. Patients were allocated into one of 2 groups (30 patients per group).
- Group I: the patients received a single-shot of 20 ml plain bupivacaine (0.5%) +2 ml normal saline. ii.Group II: the patients received 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml).
Postoperative pain were assessed by Numeric Rating Scale (N.R.S) every 6 h post-operatively for 24 h.
Whenever, the NRS Score was ≥4 or the patient requested pain medication, analgesia was provided by ketorolac 30 mg amp IV, then morphine 1mg ̸ kg slowly IV as a rescue analgesia. Time to first request for analgesia \& total dose of rescue analgesia were be recorded.
- Satisfaction score will be measured on a linear numerical scale; ranging from 0 = complete dissatisfaction to 10 = complete satisfaction. Any post-operative side effects, like nausea, vomiting, bradycardia, hypotension will be also documented. The time to first analgesic requirement will be recorded, and the cumulative, post-operative opioid consumption in 24 h post-operatively will be recorded. Assessment of Quadriceps Strength at preoperative, 6, 12, 18, and 24 h postoperative from zero to 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Active comparator | Drug: Saline SolutionGroup I (MS): received single shot 20 ml 0.5% isobaric bupivacaine + 2.0 ml normal saline solution injected into the adductor canal preoperatively. |
| group II | Active comparator | Drug: DexamethasoneGroup II (MD): received 20 ml 0.5% isobaric bupivacaine + 8.0 mg dexamethasone (2.0 ml) injected into adductor canal preoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult ASA I-II Arthroscopic anterior cruciate ligament reconstruction
Key exclusion criteria (3 listed)
- patient refusal
- drug allergy
- failed procedure
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 |
|---|---|---|
| Saline SolutionAlso: Normal Saline SolutionInjected in the adductor canal | Drug | group I |
| DexamethasoneAlso: DecadronInjected in the adductor canal | Drug | group II |
Primary outcome
duration of postoperative analgesia
Time frame: One day postoperative
assessed by pain score
1 secondary outcome
postoperative analgesic consumption
Time frame: One day postoperative
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 4 Aug 2017.
- Results publication: PubMed 28656158Rasouli MR, Viscusi ER. Adductor Canal Block for Knee Surgeries: An Emerging Analgesic Technique. Arch Bone Jt Surg. 2017 May;5(3):131-132. No abstract available.
- Derived from this study: PubMed 30066465Ibrahim AS, Aly MG, Farrag WS, Gad El-Rab NA, Said HG, Saad AH. Ultrasound-guided adductor canal block after arthroscopic anterior cruciate ligament reconstruction: Effect of adding dexamethasone to bupivacaine, a randomized controlled trial. Eur J Pain. 2019 Jan;23(1):135-141. doi: 10.1002/ejp.1292. Epub 2018 Aug 6.
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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 study testing Saline Solution and Dexamethasone in people with Postoperative Analgesia, run by Assiut University.
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 4 Aug 2017. 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.
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: One day postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03239314, which also lists 2 linked publications.
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 4 Aug 2017.