Adductor Canal BlockPhase 4NCT05742958
The Quality of Recovery After Intrathecal Morphine or Adductor Canal Block in Anterior Cruciate Ligament Reconstruction
A Phase 4 study testing Intrathecal morphine and Adductor canal block in people with Adductor Canal Block and Intrathecal Morphine, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The Quality of Recovery 40 (QoR-40) is a multidimensional questionnaire that addresses many aspects of postoperative recovery. The QoR-40 has been used many times to measure the recovery of patients after different surgeries, and this questionnaire seems to be a reliable tool for evaluating anesthesia-related… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adductor Canal Block, Intrathecal Morphine, Arthroscopic Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Intrathecal morphine and Adductor canal block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jun 2023to 30 Sep 2023
- Phase
- Phase 4
- 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 of Anesthesiologists (ASA) physical status I or II adult patients aged 18-65 years undergoing elective arthroscopic anterior cruciate ligament reconstruction will be included in the study.
Who cannot join
- We will exclude patients with known coagulopathy, allergies to the studied drugs, obesity (BMI >35kg/m2), renal and/or hepatic insufficiency, chronic pain syndrome, mental impairment, depression, chronic alcoholism, and usage of antidepressant and analgesic drugs before surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cukurova University
Adana, Saricam, 01330
Demet Laflı Tunay, MD, +905358685831, dlafli@yahoo.com
About this study
Official title: The Quality of Recovery After Intrathecal Morphine or Adductor Canal Block Added to Spinal Anesthesia in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
The Quality of Recovery 40 (QoR-40) is a multidimensional questionnaire that addresses many aspects of postoperative recovery. The QoR-40 has been used many times to measure the recovery of patients after different surgeries, and this questionnaire seems to be a reliable tool for evaluating anesthesia-related techniques, including regional anesthesia. Arthroscopic knee surgery causes moderate to severe postoperative pain for most patients. Various methods such as different systemic drugs, peripheral or central blocks and intra-articular injections have been developed for the effective, safe and long-term control of this pain. In recent years, it has been shown that regional anesthesia techniques reduce the need for opioids in orthopedic ambulatory surgeries and accelerate recovery and discharge. However, there is no consensus on which is the best approach among these various regional techniques. However, adductor canal block (ACB) and intrathecal morphine (ITM) are the preferred regional methods in the perioperative pain management of knee surgery. In this study, it was aimed to test the effectiveness of intrathecal morphine or adductor canal block added to spinal anesthesia on the quality of recovery in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery.
- Conditions
- Adductor Canal Block, Intrathecal Morphine, Arthroscopic Anterior Cruciate Ligament Reconstruction, Quality of Recovery
- Being tested
- Intrathecal morphine, Adductor canal block
- Keywords
- intrathecal morphine, adductor canal block, quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphineDrug
The study will be conducted in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery under spinal anesthesia. In this arm, 0.1 mg intrathecal morphine in addition to spinal anesthesia will be used for perioperative pain management. A placebo addctor canal block will also be performed for masking in these patients. The quality of recovery will be evaluated with a postoperative quality of recovery scale (QoR-40 questionnaire) at postoperative 24-hour and 14-day.
Adductor canal blockDrug
After providing complete sensory block in the lower extremities with spinal anesthesia, the thigh where the surgery will be performed will be brought into slight abduction and external rotation while the patient is in the supine position. The blockage of the saphenous nerve in the adductor canal will be performed with 30 mL of local anesthetic (0.25% bupivacaine) solution with a 22 gauge 5-8 cm long block needle from the mid-medial part of the thigh under ultrasound guidance. The quality of recovery will be evaluated with QoR-40 questionnaire at postoperative 24-hour and 14-day.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine (Group ITM) | Experimental | 12.5-15 mg hyperbaric 0.5% bupivacaine + 0.1 mg (0.1 mL) morphine with a single dose intrathecal injection through the L4-L5 interval (spinal anesthesia) + placebo adductor canal block (with 30 mL saline) will be administered. Receives: Drug: Intrathecal morphine |
| Adductor canal block (Group ACB) | Experimental | Spinal anesthesia from L4-L5 interval with 12.5-15 mg hyperbaric 0.5% bupivacaine + adductor canal block (30 mL 0.25% bupivacaine) will be applied. Receives: Drug: Adductor canal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Quality of Recovery-40 (QoR-40) questionnaire scores
The score ranges from 40 to 200. A higher score on the QoR-40 means better recovery following arthroscopic anterior cruciate ligament reconstruction.
Measured: Postoperative 24-hour.
Secondary outcomes (5)
Numeric Rating Score (NRS)
Numeric rating score for postoperative pain intensity. Pain intensity will be evaluated using a numeric rating scale with descriptive terms at intervals along a horizontal line of 10 cm length: 0 mm = no pain, 10 cm = worst pain imaginable.
Measured: Postoperative 1, 2, 4, 8, 12 and 24-hour.
Supplement analgesia requirement
Amount of additional analgesics taken outside of the usual treatment protocol.
Measured: Postoperative 1, 2, 4, 8, 12 and 24-hour.
The time to first postoperative mobilisation
Ambulation time
Measured: Duration of postoperative 24-hour
Discharge time
Length of hospital stay
Measured: Duration of postoperative 24-hour
Treatment satisfaction
Treatment satisfaction will be assessed at 24 h using a 3-point rating scale ranging from 1 to 3: 1 = excellent satisfaction (Numeric Rating Score/NRS=0), 2 = good satisfaction (NRS=1-2), 3 = dissatisfaction (NRS=3-4)
Measured: Postoperative 24-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start7 Jun 2023
- Primary completion15 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adductor Canal BlockStudies of the same condition, open and under way.
- More trials run by Cukurova 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Laflı Tunay, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742958
- Sponsor's protocol ID
- Cukurova Univ
- Status last verified
- Sep 2023
- First submitted
- 5 Feb 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant code, age, weight, height and information during surgery will be recorded. This information will not be shared with any person or organization.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Quality of Recovery After Intrathecal Morphine or Adductor Canal Block Added to Spinal Anesthesia in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05742958
- Acronym / sponsor ID
- Cukurova Univ
- Conditions
- Adductor Canal Block, Intrathecal Morphine, Arthroscopic Anterior Cruciate Ligament Reconstruction, Quality of Recovery
- Keywords
- intrathecal morphine, adductor canal block, quality of recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 24 Feb 2023 (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 Quality of Recovery 40 (QoR-40) is a multidimensional questionnaire that addresses many aspects of postoperative recovery. The QoR-40 has been used many times to measure the recovery of patients after different surgeries, and this questionnaire seems to be a reliable tool for evaluating anesthesia-related techniques, including regional anesthesia. Arthroscopic knee surgery causes moderate to severe postoperative pain for most patients. Various methods such as different systemic drugs, peripheral or central blocks and intra-articular injections have been developed for the effective, safe and long-term control of this pain. In recent years, it has been shown that regional anesthesia techniques reduce the need for opioids in orthopedic ambulatory surgeries and accelerate recovery and discharge. However, there is no consensus on which is the best approach among these various regional techniques. However, adductor canal block (ACB) and intrathecal morphine (ITM) are the preferred regional methods in the perioperative pain management of knee surgery. In this study, it was aimed to test the effectiveness of intrathecal morphine or adductor canal block added to spinal anesthesia on the quality of recovery in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine (Group ITM) | Experimental | Drug: Intrathecal morphine12.5-15 mg hyperbaric 0.5% bupivacaine + 0.1 mg (0.1 mL) morphine with a single dose intrathecal injection through the L4-L5 interval (spinal anesthesia) + placebo adductor canal block (with 30 mL saline) will be administered. |
| Adductor canal block (Group ACB) | Experimental | Drug: Adductor canal blockSpinal anesthesia from L4-L5 interval with 12.5-15 mg hyperbaric 0.5% bupivacaine + adductor canal block (30 mL 0.25% bupivacaine) will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I or II adult patients aged 18-65 years undergoing elective arthroscopic anterior cruciate ligament reconstruction will be included in the study.
Key exclusion criteria (1 listed)
- We will exclude patients with known coagulopathy, allergies to the studied drugs, obesity (BMI >35kg/m2), renal and/or hepatic insufficiency, chronic pain syndrome, mental impairment, depression, chronic alcoholism, and usage of antidepressant and analgesic drugs before surgery.
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 |
|---|---|---|
| Intrathecal morphineThe study will be conducted in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery under spinal anesthesia. In this arm, 0.1 mg intrathecal morphine in addition to spinal anesthesia will be used for perioperative pain management. A placebo addctor canal block will also be performed for masking in these patients. The quality of recovery will be evaluated with a postoperative quality of recovery scale (QoR-40 questionnaire) at postoperative 24-hour and 14-day. | Drug | Intrathecal morphine (Group ITM) |
| Adductor canal blockAfter providing complete sensory block in the lower extremities with spinal anesthesia, the thigh where the surgery will be performed will be brought into slight abduction and external rotation while the patient is in the supine position. The blockage of the saphenous nerve in the adductor canal will be performed with 30 mL of local anesthetic (0.25% bupivacaine) solution with a 22 gauge 5-8 cm long block needle from the mid-medial part of the thigh under ultrasound guidance. The quality of recovery will be evaluated with QoR-40 questionnaire at postoperative 24-hour and 14-day. | Drug | Adductor canal block (Group ACB) |
Primary outcome
24-hour Quality of Recovery-40 (QoR-40) questionnaire scores
Time frame: Postoperative 24-hour.
The score ranges from 40 to 200. A higher score on the QoR-40 means better recovery following arthroscopic anterior cruciate ligament reconstruction.
5 secondary outcomes
Numeric Rating Score (NRS)
Time frame: Postoperative 1, 2, 4, 8, 12 and 24-hour.
Supplement analgesia requirement
Time frame: Postoperative 1, 2, 4, 8, 12 and 24-hour.
The time to first postoperative mobilisation
Time frame: Duration of postoperative 24-hour
Discharge time
Time frame: Duration of postoperative 24-hour
Treatment satisfaction
Time frame: Postoperative 24-hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No. Participant code, age, weight, height and information during surgery will be recorded. This information will not be shared with any person or organization.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal morphine and Adductor canal block in people with Adductor Canal Block and Intrathecal Morphine, run by Cukurova University at 1 site in Turkey (Türkiye).
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 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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 Turkey (Türkiye). 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour Quality of Recovery-40 (QoR-40) questionnaire scores (time frame: Postoperative 24-hour.). 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 13 Sep 2023.