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NCT02805920

Comparison Between 3 Solutions of Bupivacaine of Adductor Canal Block for Anterior Cruciate Ligament Reconstruction

Completed NA Last updated 14 August 2018
What this trial tests

NA trial testing Bupivacaine in Postoperative Pain in 90 participants. Completed in 30 June 2017.

Timeline
30 August 2016
Primary endpoint
30 April 2017
30 June 2017

Quick facts

Lead sponsorProcare Riaya Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingtriple
Primary purposetreatment
Enrollment90
Start date30 August 2016
Primary completion30 April 2017
Estimated completion30 June 2017
Sites2 locations across Saudi Arabia

Drugs / interventions tested

Conditions studied

Sponsor

Procare Riaya Hospital

Who can join

Adults 18 to 50, male only, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Adductor canal block (ACB) is a new technique gaining acceptance as an alternative analgesic method of femoral nerve block (FNB) following knee surgery. The advantage of ACB is its dominant sensory nerve block effect. It preserves quadriceps muscle strength compared with the FNB. This will serve as potential gain for early rehabilitation and thereby functional outcome. Adequate direct injection of local anesthetic into the canal will block four nerves: the saphenous nerve, the nerve to the vastus medialis, the medial femoral cutaneous nerve, and the terminal end of the posterior division of the obturator nerve. Anterior cruciate ligament reconstruction (ACLR) is often associated with postoperative severe pain. Postoperative early rehabilitation is the primary focus to restore pre-injury status and is an essential part of the full recovery, especially that this rehabilitation extents over a 6 month period. Early elimination of pain is necessary to achieve this goal. However, there are no clear conclusive clinical reports defining the adequate analgesic volume-dosage of local anesthetic for ACB for postoperative ACL pain management. The investigators speculated that volume-dosage manipulation play key role in the effective of ACB for postoperative pain. The investigators conducted this prospective, randomized, observer-blinded trial to compare 3 combinations of volume and dosage of 0.25 % bupivacaine for US-guided ACB. The first aim of the investigation is to compare the analgesic effect of ACB 0.25% bupivacaine of the 3 doses as assessed by the visual analog scale (VAS) pain scores. The second aim were duration of analgesia, as defined by first demand for analgesia, and subsequent 24-h consumption. Physiotherapy tolerance and time to discharge were evaluated. Side effects were also assessed.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Bupivacaine

Trials testing the same drug.

Other recruiting trials for Postoperative Pain

Currently open trials in the same condition.

Other Procare Riaya Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing