Postoperative PainPhase 2NCT04715152
ACB Versus IA Analgesia in Knee Arthroscopy
A Phase 2 study testing ACB group and IA group in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Reconstruction of the anterior cruciate ligament (ACL) of the knee is a painful procedure, and effective postoperative analgesia is important for early return of patient activity. 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?
- ACB group and IA group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2021to 31 Jul 2023
- Phase
- Phase 2
- 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
- Patients undergoing elective arthroscopic reconstruction of the anterior cruciate ligament (ACL) under spinal anesthesia, aged from 18 to 65 years old
Who cannot join
- Contraindications to peripheral nerve block (e.g. allergy to local anesthetics, coagulopathy, infection in the area)
- History of cardiovascular, cerebrovascular, and respiratory diseases
- Preexisting neuropathies
- Chronic pain syndrome
- Opioid dependence
- Patients with diabetes mellitus, sever hypertension, hepatic or renal dysfunction
- Pregnancy
- Not willingness to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adductor Canal Block Versus Intra-articular Analgesia for Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction: a Randomized Trial
Reconstruction of the anterior cruciate ligament (ACL) of the knee is a painful procedure, and effective postoperative analgesia is important for early return of patient activity.
Read the detailed description
Reconstruction of the anterior cruciate ligament (ACL) of the knee is a painful procedure, with postoperative analgesia providing patient comfort, early mobilization, and discharge within 24 hours.
Various methods for postoperative analgesia management are available, such as systemic opioids, epidural local anesthetic, peripheral nerve block and local anesthetic infiltration analgesia. Use of systemic opioids can cause adverse effects that may affect functional rehabilitation, such as nausea, vomiting, pruritus, sedation and respiratory depression. Hypotension, urinary retention, and pruritus are more common in patients with epidural analgesia. In addition, use of long-acting intrathecal opioids causes adverse effects such as bilateral motor block, tremor and hypotension. Systemic and intrathecal methods for postoperative analgesia are gradually being abandoned because of these negative effects.
The saphenous nerve is the largest contributor to sensory perception around the knee, while the adductor canal contains the nerve to the vastus medialis, the medial femoral cutaneous nerve, the medial retinacular nerve, articular branches from the posterior division of the obturator nerve and occasionally the anterior branch of the obturator nerve. Although adductor canal block (ACB) can contribute towards motor blockade of the periarticular musculature, its effect on functional weakness of the quadriceps has been reported to be minimal, compared with femoral nerve block (FNB).
Intra-articular (IA) local anesthetic agents have been used either alone or in combination with other agent. However, it was observed that use of combination of drug is better than single drug for prevention of postoperative pain, providing synergistic effect and reducing side effects compared to high dose of single drug.
Dexamethasone is a potent and highly selective glucocorticoid with minimal mineralocorticoid effect. It blocks the nociceptive impulse transmission along the myelinated C fibers. Dexamethasone prolongs the duration of regional blocks, when combined with local anesthetics.
- Conditions
- Postoperative Pain
- Being tested
- ACB group, IA group
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACB groupDrug
Patients will receive ultrasound-guided (USG) ACB with bupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline
IA groupDrug
Patients will receive intra-articular bupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline
| Study group | Role | What they receive |
|---|---|---|
| ACB group | Active comparator | Patients will receive ultrasound-guided (USG) ACB with bupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline. Receives: Drug: ACB group |
| IA group | Placebo comparator | Patients will receive intra-articular bupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline. Receives: Drug: IA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain free time after surgery
assessed in minutes
Measured: 1440 minutes (24 hours) 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 Jan 2021
- Study start20 May 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
- Investigators
- Seham M Moeen, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715152
- Sponsor's protocol ID
- SM 1 2021
- Status last verified
- Jun 2024
- First submitted
- 15 Jan 2021
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block Versus Intra-articular Analgesia for Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04715152
- Acronym / sponsor ID
- SM 1 2021
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 20 Jan 2021 (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.
Reconstruction of the anterior cruciate ligament (ACL) of the knee is a painful procedure, and effective postoperative analgesia is important for early return of patient activity.
Detailed description
Reconstruction of the anterior cruciate ligament (ACL) of the knee is a painful procedure, with postoperative analgesia providing patient comfort, early mobilization, and discharge within 24 hours.
Various methods for postoperative analgesia management are available, such as systemic opioids, epidural local anesthetic, peripheral nerve block and local anesthetic infiltration analgesia. Use of systemic opioids can cause adverse effects that may affect functional rehabilitation, such as nausea, vomiting, pruritus, sedation and respiratory depression. Hypotension, urinary retention, and pruritus are more common in patients with epidural analgesia. In addition, use of long-acting intrathecal opioids causes adverse effects such as bilateral motor block, tremor and hypotension. Systemic and intrathecal methods for postoperative analgesia are gradually being abandoned because of these negative effects.
The saphenous nerve is the largest contributor to sensory perception around the knee, while the adductor canal contains the nerve to the vastus medialis, the medial femoral cutaneous nerve, the medial retinacular nerve, articular branches from the posterior division of the obturator nerve and occasionally the anterior branch of the obturator nerve. Although adductor canal block (ACB) can contribute towards motor blockade of the periarticular musculature, its effect on functional weakness of the quadriceps has been reported to be minimal, compared with femoral nerve block (FNB).
Intra-articular (IA) local anesthetic agents have been used either alone or in combination with other agent. However, it was observed that use of combination of drug is better than single drug for prevention of postoperative pain, providing synergistic effect and reducing side effects compared to high dose of single drug.
Dexamethasone is a potent and highly selective glucocorticoid with minimal mineralocorticoid effect. It blocks the nociceptive impulse transmission along the myelinated C fibers. Dexamethasone prolongs the duration of regional blocks, when combined with local anesthetics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACB group | Active comparator | Drug: ACB groupPatients will receive ultrasound-guided (USG) ACB with bupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline. |
| IA group | Placebo comparator | Drug: IA groupPatients will receive intra-articular bupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective arthroscopic reconstruction of the anterior cruciate ligament (ACL) under spinal anesthesia, aged from 18 to 65 years old
Key exclusion criteria (8 listed)
- Contraindications to peripheral nerve block (e.g. allergy to local anesthetics, coagulopathy, infection in the area)
- History of cardiovascular, cerebrovascular, and respiratory diseases
- Preexisting neuropathies
- Chronic pain syndrome
- Opioid dependence
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 |
|---|---|---|
| ACB groupPatients will receive ultrasound-guided (USG) ACB with bupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline | Drug | ACB group |
| IA groupPatients will receive intra-articular bupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline | Drug | IA group |
Primary outcome
The pain free time after surgery
Time frame: 1440 minutes (24 hours) after surgery
assessed in minutes
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 14 Jun 2024.
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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.
Seham M Moeen, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACB group and IA group in people with Postoperative Pain, run by Assiut University at 1 site 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 8 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 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The pain free time after surgery (time frame: 1440 minutes (24 hours) 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 14 Jun 2024.