NCT07813715

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 4, 2026

Last Update Submit

September 17, 2026

Conditions

Keywords

AdrenalineArthroscopyIntra-articularTourniquet

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1.5 years

Study Arms (2)

Adrenaline Administration

EXPERIMENTAL
Procedure: Adrenaline

Tourniquet Administration

ACTIVE COMPARATOR
Procedure: Tourniquet

Interventions

TourniquetPROCEDURE

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.

Tourniquet Administration
AdrenalinePROCEDURE

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)

Adrenaline Administration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, Bagmati, 45200, Nepal

Location

Related Publications (4)

  • 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.

    PMID: 12172716BACKGROUND
  • Zhongyu 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.

    PMID: 37009621BACKGROUND
  • Kirkley 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.

    PMID: 10705321BACKGROUND
  • Noordin 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.

    PMID: 19952261BACKGROUND

MeSH Terms

Interventions

TourniquetsEpinephrine

Intervention Hierarchy (Ancestors)

Equipment and SuppliesEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 10, 2026

Study Start

January 1, 2023

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

September 22, 2026

Record last verified: 2026-09

Locations