Knee ArthroscopyNCT07813715
Intra-Articular Adrenaline Versus Tourniquet in Knee Arthroscopy: A Cohort Study
A study testing Tourniquet and Adrenaline in people with Knee Arthroscopy and Visualization, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
Trial summary
Arthroscopy has become one of the most commonly performed orthopedic surgeries in the world due to it being a minimally invasive technique. Clear visualization is crucial for both safe and efficient arthroscopic procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroscopy, Visualization, Adrenaline
- What is being tested?
- Tourniquet and Adrenaline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2023to 31 Jul 2024
- 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
- Patients who are skeletally matured (18 year and above) undergoing knee arthroscopic surgeries.
- The surgeries included are:
- Anterior Cruciate Ligament reconstruction
- Anterior Cruciate Ligament repair
- Anterior Cruciate Ligament decompression
- Meniscus repair surgeries
- Meniscus resection surgeries - Patients who provide consent for the study
Who cannot join
- The patient with following procedures are excluded:
- Posterior Cruciate Ligament (PCL) surgeries
- Multi-ligament surgeries
- Osteochondral or intra articular fractures
- Patients under 18 years of age
- Patients who do not provide consent
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Dhulikhel Hospital, Kathmandu University Hospital
Dhulikhel, Bagmati, 45200
About this study
Official title: Intra-Articular Adrenaline Versus Tourniquet in Knee Arthroscopy in a Tertiary Care Center: A Prospective Cohort Study
Arthroscopy has become one of the most commonly performed orthopedic surgeries in the world due to it being a minimally invasive technique. Clear visualization is crucial for both safe and efficient arthroscopic procedures. Pneumatic tourniquet has been widely used in knee arthroscopic surgeries to obtain bloodless surgical field, improve visualization, and thereby surgical time. However, complications from tourniquet use are not uncommon, particularly in patients whose procedure takes longer than 60 minutes. Using a tourniquet could increase problems, such as electromyographic alterations, nerve compressions, arterial occlusions, delayed muscle recovery, and muscle weakness.
Intra-articular adrenaline injection creates a bloodless field by reducing local perfusion through its vasoconstrictive properties, mimicking the effect of a tourniquet. It appeared to be a potentially effective and safe option. Therefore, this study aimed to evaluate intra-articular adrenaline infiltration as an alternative for achieving a bloodless field without tourniquet-related side effects, in terms of clinical efficacy, operative duration and safety. We would compare intra operative visibility and safety of intra articular adrenaline (1:200,000) injections with use of a tourniquet in arthroscopic knee surgeries. Comparison is made between one group that received standard tourniquet application and another group that received intra articular adrenaline injection. Then the intraoperative visibility in these two groups is compared using tools like surgeon visual analogue score and amount of irrigation fluid required. The effectiveness and safety of the method used is compared using appropriate statistical tools.
Read more
Null Hypothesis: There is no difference in intraoperative visibility and safety during knee arthroscopic surgeries with standard tourniquet application versus intraarticular adrenaline injection.
H0: outcome in Adrenaline group =< outcome in Tourniquet group
Alternative Hypothesis: Intra articular adrenaline injection is better than tourniquet use in arthroscopic knee surgeries with respect to operative field visibility and safety.
H1: outcome in Adrenaline group > or (not less than) outcome in Tourniquet group
- Conditions
- Knee Arthroscopy, Visualization, Adrenaline, Tourniquet, Outcome
- Being tested
- Tourniquet, Adrenaline
- Keywords
- Adrenaline, Arthroscopy, Intra-articular, Tourniquet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TourniquetProcedure or surgery
The tourniquet in all groups are applied over proximal thigh with well-padded cotton and inflated (only in Group A - Tourniquet Administration Group's) to 100 -150mm of Hg higher than systolic pressure of the patient. Other group - Group B, have no inflation of tourniquet, but only applied.
AdrenalineProcedure or surgery
Both groups will be injected at portal and intra-articular with an injection solution (Group A will be infiltrated with 60 ml of normal saline only and Group B will be injected with 60 ml of 1:200,000 adrenaline diluted in 100 ml of normal saline)
| Study group | Role | What they receive |
|---|---|---|
| Adrenaline Administration | Experimental | Not described Receives: Procedure: Adrenaline |
| Tourniquet Administration | Active comparator | Not described Receives: Procedure: Tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Visibility Assessed by Surgeon Visual Analogue Scale (VAS)
Intraoperative visibility during arthroscopic knee surgery will be assessed by the operating surgeon using a 10-point Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates excellent visibility and 10 indicates extremely poor visibility. Lower scores indicate better operative visibility.
Measured: 1.5 years
Intraoperative Irrigation Fluid Requirement
The total volume of irrigation fluid used during arthroscopic knee surgery will be recorded in milliliters (mL). Lower irrigation fluid requirement indicates better operative visibility and efficiency.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Jan 2023
- Primary completion30 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee ArthroscopyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohit Shrestha, Kathmandu University School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813715
- Sponsor's protocol ID
- 31/24
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karaoglu S, Dogru K, Kabak S, Inan M, Halici M. Effects of epinephrine in local anesthetic mixtures on hemodynamics and view quality during knee arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2002 Jul;10(4):226-8. doi: 10.1007/s00167-001-0257-8. Epub 2001 Nov 23.
PubMed 12172716Zhongyu X, Zhen Y, Bingqing G, Xintian K, Meifeng G, Jianda X. Intra-articular administration of adrenaline plus an irrigation pump system for visibility during the arthroscopic reconstruction of multiple knee ligaments without a tourniquet. Front Surg. 2023 Mar 17;10:1045839. doi: 10.3389/fsurg.2023.1045839. eCollection 2023.
PubMed 37009621Kirkley A, Rampersaud R, Griffin S, Amendola A, Litchfield R, Fowler P. Tourniquet versus no tourniquet use in routine knee arthroscopy: a prospective, double-blind, randomized clinical trial. Arthroscopy. 2000 Mar;16(2):121-6. doi: 10.1016/s0749-8063(00)90024-0.
PubMed 10705321Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.
PubMed 19952261
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Articular Adrenaline Versus Tourniquet in Knee Arthroscopy in a Tertiary Care Center: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07813715
- Acronym / sponsor ID
- 31/24
- Conditions
- Knee Arthroscopy, Visualization, Adrenaline, Tourniquet, Outcome
- Keywords
- Adrenaline, Arthroscopy, Intra-articular, Tourniquet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 10 Sep 2026 (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.
Arthroscopy has become one of the most commonly performed orthopedic surgeries in the world due to it being a minimally invasive technique. Clear visualization is crucial for both safe and efficient arthroscopic procedures. Pneumatic tourniquet has been widely used in knee arthroscopic surgeries to obtain bloodless surgical field, improve visualization, and thereby surgical time. However, complications from tourniquet use are not uncommon, particularly in patients whose procedure takes longer than 60 minutes. Using a tourniquet could increase problems, such as electromyographic alterations, nerve compressions, arterial occlusions, delayed muscle recovery, and muscle weakness.
Intra-articular adrenaline injection creates a bloodless field by reducing local perfusion through its vasoconstrictive properties, mimicking the effect of a tourniquet. It appeared to be a potentially effective and safe option. Therefore, this study aimed to evaluate intra-articular adrenaline infiltration as an alternative for achieving a bloodless field without tourniquet-related side effects, in terms of clinical efficacy, operative duration and safety. We would compare intra operative visibility and safety of intra articular adrenaline (1:200,000) injections with use of a tourniquet in arthroscopic knee surgeries. Comparison is made between one group that received standard tourniquet application and another group that received intra articular adrenaline injection. Then the intraoperative visibility in these two groups is compared using tools like surgeon visual analogue score and amount of irrigation fluid required. The effectiveness and safety of the method used is compared using appropriate statistical tools.
Null Hypothesis: There is no difference in intraoperative visibility and safety during knee arthroscopic surgeries with standard tourniquet application versus intraarticular adrenaline injection.
H0: outcome in Adrenaline group =< outcome in Tourniquet group
Alternative Hypothesis: Intra articular adrenaline injection is better than tourniquet use in arthroscopic knee surgeries with respect to operative field visibility and safety.
H1: outcome in Adrenaline group > or (not less than) outcome in Tourniquet group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adrenaline Administration | Experimental | Procedure: Adrenaline |
| Tourniquet Administration | Active comparator | Procedure: Tourniquet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who are skeletally matured (18 year and above) undergoing knee arthroscopic surgeries.
- Anterior Cruciate Ligament reconstruction
- Anterior Cruciate Ligament repair
- Anterior Cruciate Ligament decompression
- Meniscus repair surgeries
Key exclusion criteria (6 listed)
- The patient with following procedures are excluded:
- Patients under 18 years of age
- Patients who do not provide consent
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 |
|---|---|---|
| TourniquetThe tourniquet in all groups are applied over proximal thigh with well-padded cotton and inflated (only in Group A - Tourniquet Administration Group's) to 100 -150mm of Hg higher than systolic pressure of the patient. Other group - Group B, have no inflation of tourniquet, but only applied. | Procedure or surgery | Tourniquet Administration |
| AdrenalineBoth groups will be injected at portal and intra-articular with an injection solution (Group A will be infiltrated with 60 ml of normal saline only and Group B will be injected with 60 ml of 1:200,000 adrenaline diluted in 100 ml of normal saline) | Procedure or surgery | Adrenaline Administration |
Primary outcome
Intraoperative Visibility Assessed by Surgeon Visual Analogue Scale (VAS)
Time frame: 1.5 years
Intraoperative visibility during arthroscopic knee surgery will be assessed by the operating surgeon using a 10-point Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates excellent visibility and 10 indicates extremely poor visibility. Lower scores indicate better operative visibility.
Intraoperative Irrigation Fluid Requirement
Time frame: 1.5 years
The total volume of irrigation fluid used during arthroscopic knee surgery will be recorded in milliliters (mL). Lower irrigation fluid requirement indicates better operative visibility and efficiency.
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 22 Sep 2026.
- Background: PubMed 12172716Karaoglu S, Dogru K, Kabak S, Inan M, Halici M. Effects of epinephrine in local anesthetic mixtures on hemodynamics and view quality during knee arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2002 Jul;10(4):226-8. doi: 10.1007/s00167-001-0257-8. Epub 2001 Nov 23.
- Background: PubMed 37009621Zhongyu X, Zhen Y, Bingqing G, Xintian K, Meifeng G, Jianda X. Intra-articular administration of adrenaline plus an irrigation pump system for visibility during the arthroscopic reconstruction of multiple knee ligaments without a tourniquet. Front Surg. 2023 Mar 17;10:1045839. doi: 10.3389/fsurg.2023.1045839. eCollection 2023.
- Background: PubMed 10705321Kirkley A, Rampersaud R, Griffin S, Amendola A, Litchfield R, Fowler P. Tourniquet versus no tourniquet use in routine knee arthroscopy: a prospective, double-blind, randomized clinical trial. Arthroscopy. 2000 Mar;16(2):121-6. doi: 10.1016/s0749-8063(00)90024-0.
- Background: PubMed 19952261Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet and Adrenaline in people with Knee Arthroscopy and Visualization, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
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 7 inclusion and 6 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 22 Sep 2026. 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 Nepal. 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.
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?
Intraoperative Visibility Assessed by Surgeon Visual Analogue Scale (VAS) (time frame: 1.5 years). The study lists 2 primary outcomes in all. 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 NCT07813715, which also lists 4 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 22 Sep 2026.