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Clinical Trials/NCT02436694
NCT02436694UnknownNot Applicable

Can the Association of Dexamethasone and Local Anaesthetic in a Single-shot Femoral and Sciatic Nerve Block Improve Analgesia Postoperatively in Patients Submitted to Total Knee Arthroplasty

Centro Hospitalar do Porto1 site in 1 country56 target enrollmentStarted: April 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
56
Locations
1
Primary Endpoint
Quantification of Pain by VAS

Study Overview

Brief Summary

Can the association of dexamethasone to the local anaesthetic in a single-shot femoral and sciatic nerve block improve analgesia postoperatively in patients submitted to total knee arthroplasty? Primary aim: Evaluate the efficacy of the association of dexamethasone to the local anaesthetic in a SSFNB and SSSNB in reducing pain scores, assessed by VAS.

Outcome measures: Mean pain scores in both groups. Secondary aims: Evaluate opioid consumption in the postoperative period (8- 12h, 24h, 48h) and assess incidence of side effects and complications (numbness, paraesthesias, weakness, site infection, haematoma and falls).

Detailed Description

All blocks are performed using nerve stimulation technique. For the SSFNB, the paravascular approach will be used to identify the femoral nerve.15 A positive location is considered when quadriceps contraction (patellar elevation) is elicited with a current of 0.4 mA or less, and 30mL of ropivacaine 0.375%, with or without 4mg of dexamethasone are injected, according to the randomization.

For the SSSNB the anterior approach will be chosen.16 The common peroneal or the tibial nerves are identified, respectively by dorsiflexion or plantar flexion of the foot, with a current of 0.4 mA or less. Depending on the allocated group, 20mL of ropivacaine 0.2%, with or without 4mg of dexamethasone are then injected. Blocks success should be assessed by the absence of thermal sensitivity on the anterior region of the thigh and the dorsum of the foot 10 minutes after the block.

The participating anaesthesiologists may use the ultrasound for visual guidance but should also use the nerve stimulator in order to maintain the homogeneity of the procedure.

Patients will then have an intravenous induction to general anesthesia, being the maintenance assured with either Desflurane or Sevoflurane. Thirty minutes before the end of the procedure all patients are given paracetamol 1000mg and ketorolac 30mg. Total doses of intraoperative analgesics are recorded.

Before surgery all patients will be explained how to use the PCA, which is connected after arrival to the post-anesthesia unit (PACU). The PCA is programmed for 1mg bolus as required by the patient, with a lockout period of 7 minutes. In what concerns the remaining post-operative analgesia, both groups are prescribed paracetamol 1000mg q8h, diclofenac 50mg q12h, and as rescue strategy, tramadol 100mg q6h.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult patients admitted foi unilaterla total knee arthroplasty

Exclusion Criteria

  • Refusal/Incapacity to give informed consent
  • Contra-indication to general anesthesia
  • Infection at needle insertion site
  • Coagulation disorders
  • Pre-existing neurologic disorders
  • Known allergy to any of the drugs from the protocol
  • ASA status >3
  • Weight<50kg
  • Inability to understand or use VAS pain score

Arms & Interventions

Local Anesthetic ropivacaíne

Active Comparator

Femoral nerve block with ropivacaine 0.375% and sciatic nerve block with ropivacaine 0.2%

Intervention: Local Anesthetic ropivacaíne (Drug)

Perineural Dexamethasone

Experimental

Femoral nerve block with ropivacaine 0.375% and perineural dexamethasone and sciatic nerve block with ropivacaine 0.2% and perineural dexamethasone

Intervention: Local Anesthetic ropivacaíne (Drug)

Perineural Dexamethasone

Experimental

Femoral nerve block with ropivacaine 0.375% and perineural dexamethasone and sciatic nerve block with ropivacaine 0.2% and perineural dexamethasone

Intervention: Perineural Dexamethasone (Drug)

Outcomes

Primary Outcomes

Quantification of Pain by VAS

Time Frame: 48 hours

Pain assessed by VAS

Secondary Outcomes

  • Morphine consumption in mg(48 hours)
  • Side-effects (numbness, paraesthesias, weakness, site infection, haematoma and falls)(48 hours)
  • Complications from technique (Motor ou sensitive changes, infection, nausea)(48 hours)

Investigators

Sponsor
Centro Hospitalar do Porto
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marta Carvalho

MD

Centro Hospitalar do Porto

Study Sites (1)

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