Analgesia in Total Knee Arthroplasty Clinical Trial
Official title:
A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
| Verified date | July 2015 |
| Source | Changi General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Total knee arthroplasty or replacement (TKA), a commonly performed surgery for
osteoarthritis of the knee, is a painful procedure and requires a multimodal analgesic
approach. A method for analgesia is local infiltration analgesia (LIA), where a mixture of
drugs is injected around the knee joint.
Adductor canal block (ACB) is an alternative regional anaesthesia technique which has been
shown to result in minimal thigh weakness.
The investigators aim to study if the analgesia provided by ACB is superior to LIA while
preserving quadriceps strength.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | March 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 45 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Patients scheduled for primary TKA under single shot spinal anaesthesia, between ages 45-85 years old, American Society of Anesthesiologists (ASA) physical status 1 to 3 and BMI 18-35 kg/m2 Exclusion Criteria: - Patients unable to give consent, inability to communicate/ cooperate, patients with regular consumption of strong opioids (morphine, oxycodone) or steroids, allergy to local anaesthetics or any drugs included in the study, patients with lower limb surgery in the preceding year, patients with pre-existing neurological deficits and patients who have contraindications for spinal anaesthesia. |
| Country | Name | City | State |
|---|---|---|---|
| Singapore | Changi General Hospital | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| Changi General Hospital |
Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Presence of Complications | Hematoma, wound infection, neurological deficits, any incidence of fall | up to 48 hours | |
| Other | Length of Hospital Stay | Number of days till discharge | Up to 30 days | |
| Primary | Morphine consumption in the first 24 hours | morphine consumption in the first 24 hours (including morphine administered in recovery and via PCA). | 24 hours | |
| Secondary | Pain Scores | Pain scores are recorded at 1, 6, 12, 24 and 48 hours post-operatively, assessed using a visual analog scale (0-100mm) at rest and during 45 degree passive flexion of knee. | 1, 6, 12, 24 hours; up to 48 hours postoperative | |
| Secondary | Morphine Consumption | The balance usage after primary outcome | At 48 hours | |
| Secondary | Postoperative Nausea and Vomiting | Presence/absence of nausea and vomiting, and total number of episodes of vomiting | Up to 48 hours | |
| Secondary | Sedation Scores | Up to 48 hours | ||
| Secondary | Quadriceps Strength | at 24 and 48 hours |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01680692 -
Continuous Femoral and Tibial Nerve Blocks in TKA Patients
|
Early Phase 1 |