Adductor Canal Block and Arthroscopic Knee Surgery, High Pain Responders

Arthroscopic Knee Surgery Clinical Trial

Official title:

The Analgesic Efficacy of the Adductor Canal Blockade in High Pain Responders After Arthroscopic Knee Surgery - a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001662
• Other study ID #: SM3-ME-13
• Secondary ID: 2013-000663-83H-
• Status: Completed
• Phase: Phase 4
• First received: April 9, 2013
• Last updated: December 5, 2013
• Start date: May 2013
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The Committees on Biomedical Research Ethics for the Capital Region of Denmark
• Study type: Interventional

Clinical Trial Summary

The investigators want to explore the analgesic effect of Adductor Canal Blockade (a peripheral nerve block) in high pain responding patients after arthroscopic knee surgery. The investigators hypothesize that the nerve block will have an abrupt analgesic effect.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Arthroscopic knee surgery, if reconstruction of Anterior Cruciate Ligament only hamstring graft 18-80 years of age BMI 18-40 ASA I-III written Consent

Exclusion Criteria:

Unable to communicate in danish, allergic reactions toward any study medication pregnancy alcohol/drug abuse daily opioid consumption scin infection (injection site)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroscopic Knee Surgery

Intervention

Procedure:
• Intervention group, block no. 1 - Ropivacain
Intervention group: 1. block ropivacaine - 2. block saline
• Control group: 1. block - saline
Control group: 1. block saline - 2. block ropivacaine

Locations

Country	Name	City	State
Denmark	Amager Hospital, University of Copenhagen, Denmark	Copenhagen	Copenhagen, Amager

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score during 45 degree flexion of the knee	Pain score during flexion of the knee 45 min. after nerve block	45 minutes after nerve block	No
Secondary	Pain score	pain score at rest: time 0,15,30,45,60,75,90 min. after first nerve block pain score during flexion of the knee: time 0,15,30,45,60,75,90 min. after first nerve block pain score during mobilisation (5m walk): 45 and 90 min after nerve block	0-90 min. after first nerveblock	No
Secondary	muscle strength	patients accesses muscle strength during walk	45 and 90 min after nerve block	No
Secondary	Opioid consumption		0-90 min after nerve block	No