NCT03239314

Brief 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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

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

October 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

July 24, 2017

Last Update Submit

August 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • duration of postoperative analgesia

    assessed by pain score

    One day postoperative

Secondary Outcomes (1)

  • postoperative analgesic consumption

    One day postoperative

Study Arms (2)

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.

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.

Drug: Dexamethasone

Interventions

Injected in the adductor canal

Also known as: Normal Saline Solution
group I

Injected in the adductor canal

Also known as: Decadron
group II

Eligibility Criteria

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

You may qualify if:

  • Adult ASA I-II Arthroscopic anterior cruciate ligament reconstruction

You may not qualify if:

  • patient refusal
  • drug allergy
  • failed procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • Ibrahim 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.

MeSH Terms

Interventions

Saline SolutionDexamethasoneCalcium Dobesilate

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Design

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

Study Record Dates

First Submitted

July 24, 2017

First Posted

August 4, 2017

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 22, 2017

Last Updated

August 4, 2017

Record last verified: 2017-08