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Does buprenorphine 0.3 mg prolongs the analgesic effect of a blockade of the femoral nerve with ropivaciane 0.2% for patients with a total knee replacement. A prospective triple-blinded placebo-controlled RCT?

Does buprenorphine 0.3 mg prolongs the analgesic effect of a blockade of the femoral nerve with ropivaciane 0.2% for patients with a total knee replacement. A prospective triple-blinded placebo-controlled RCT? - what painperception temgesic ad femoral blockade with ropivacaine?

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37162
Enrollment
63
Registered
2012-07-09
Start date
2012-08-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anaesthesie, pijnbehandeling pain perception total knee replacement.

Interventions

It is in this research to an evaluation study assessing the effect of the intervention is viewed (buprenorphine as an additive in femoralisblokkade

Sponsors

Westfries Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18-80 years. Elective total knee replacement,

Exclusion criteria

Exclusion criteria: Fever, temperature higher than 37.5 degrees Celsius (orthopedic surgery don*t proceed) Allergy to local anesthetics Allergy to buprenorphine pregnancy Opiate use pre existent for surgery, Infection of the skin at the area of the needle insertion opening in favor of Vagus femoralisblokkade. Revision surgery of the knee. General anesthesia instead of spinal anesthesia. If patient is not under full anesthetic protocol policy for prosthetic hip and knee surgery. EGFR

Design outcomes

Primary

MeasureTime frame
Does 0.3 mg of buprenorphine as an additive in femoral nerve blockade prolongs analgesia?

Secondary

MeasureTime frame
1. Does buprenorphine 0.3 mg as an additive in nerve femoralisblokkade give a reduction of postoperative opiate use the first 24-48 hours postoperatively? 2. Does buprenorphine 0.3 mg subcutaneously given the same effect as if close to nerve femoralisblokkade administered? 3. Does buprenorphine 0.3 mg as an additive in nerve femoralisblokkade increase nausea during the first 24 hours postoperatively. 4. Does buprenorphine 0.3 mg as an additive in nerve femoralisblokkade give a reduction of VAS score postoperatively? 5. Does buprenorphine 0.3 mg as an additive in a patient with nervus femoralisblokkade the first 24 hours postoperatively better mobilization (definedd as 30mtr walking)? 6. Does buprenorphine 0.3 mg as an additive in nerve femoralisblokkade produce a higher quality of life (QOL) score the first 24 hours postoperatively? 7. Does buprenorphine 0.3 mg as an additive prolonged nerve femoralisblokkade analgesia compared with a nerve femoralisblokkade without buprenorphine 0.3 mg? 8. Does buprenorphine 0.3 mg as an additive in nerve femoralisblokkade immediately postoperatively improved sleep? 9. Does buprenorphine 0.3 mg as an additive in femoralisblokkade nerve in orthopedic follow-up after 8 weeks show of a difference in knee function? 10. subcutaneous administration of 0.3 mg of buprenorphine give the same results measured on the above variables, with respect to a dose of 0.3 mg of buprenorphine in the femoral nerve?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)