A Phase 4 interventional study of Bupivacaine hydrochloride and Physiological Saline in Musculoskeletal Pain and Hip Injuries, sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-12.
Sponsored by Parc de Salut Mar · Phase 4, Interventional, and Treatment
A randomized double-blind clinical trial was performed. There were 4 groups according to catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2) Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial catheter + placebo. The anesthetics infusion contained bupivacaine (bolus + continuous perfusion up to 36 hours). The placebo solution consisted in physiological serum (bolus + continuous perfusion up to 36 hours). Randomization was performed in the hospital pharmacy and the surgeon kept out the surgical field when the resident placed the catheter. The same conventional analgesic schedule was prescribed to all patients: PCA (patient controlled analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. The pain was evaluated by means of PCA (patient controlled analgesia) shots and the VAS (visual analog scale). Side effects, time to start rehabilitation and time to discharge were also analyzed. A statistical analysis was performed to compare all this variables between the 4 groups (SPSS 18.0).
493 studies on the registry are indexed under Musculoskeletal Pain; 114 are open to participants now.
This study's enrollment of 100 is above the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →Parc de Salut Mar is the lead sponsor of 180 studies on the registry; 27 are open to participants now.
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Intraarticular infusion with Bupivacaine Hydrochloride
Drug: Bupivacaine hydrochloride
Infusion of Physiological Saline \[Flebobag Salina Fisiologica Grifols 0.9%\] Sterile Solution by intraarticular catheter
Other: Physiological Saline
Perifascial infusion with Bupivacaine Hydrochloride
Drug: Bupivacaine hydrochloride
Infusion of Physiological Saline \[Flebobag Salina Fisiologica Grifols 0.9%\] Sterile Solution by Perifascial catheter
Other: Physiological Saline
Intraarticular infusion with bupivacaine
Also known as: Bupivacaine / epinephrine, Vivacaine
Intraarticular infusion physiological serum
Also known as: Flebobag Salina Fisiologica Grifols 0.9%
Change in pain measured with a visual analog scale
Visual analog pain scale score every eight hours for 36 hours postoperatively
Time frame: 36 hours
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Parc de Salut Mar