The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement (ILIACPCPTHR)

Parc de Salut Mar

Status and phase: Completed; Phase 4

Conditions: Hip Injuries; Musculoskeletal Pain

Treatments: Other: Physiological Saline; Drug: Bupivacaine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02630160

2013/5138/I

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary total Hip Replacement

Exclusion criteria

• Allergic to Bupivacaine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 4 patient groups, including a placebo group

Intraarticular Catheter with anesthesic

Active Comparator group

Description:

Intraarticular infusion with Bupivacaine Hydrochloride

Treatment:

Drug: Bupivacaine hydrochloride

Intraarticular Physiological Saline

Placebo Comparator group

Description:

Infusion of Physiological Saline \[Flebobag Salina Fisiologica Grifols 0.9%\] Sterile Solution by intraarticular catheter

Treatment:

Other: Physiological Saline

Perifascial Catheter with anesthesic

Active Comparator group

Description:

Perifascial infusion with Bupivacaine Hydrochloride

Treatment:

Drug: Bupivacaine hydrochloride

Perifascial Physiological Saline

Placebo Comparator group

Description:

Infusion of Physiological Saline \[Flebobag Salina Fisiologica Grifols 0.9%\] Sterile Solution by Perifascial catheter

Treatment:

Other: Physiological Saline