A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty

Sponsor
Changi General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02104934
Collaborator
(none)
40
1
2
24
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Adductor Canal Block
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Local Infiltration Analgesia

The Local Infiltration Analgesia group will receive local infiltration of ropivacaine 150mg, ketorolac 30mg, morphine 10mg, adrenaline 200mcg and vancomycin 500mg in a total volume of 75mls by the surgeon.

Active Comparator: Adductor Canal Block

The Adductor Canal Block group of patients will receive intravenous ketorolac 30mg intra-operatively and an adductor canal block at the end of surgery. The block will be performed under real time ultrasound guidance and 30mls of 0.5% ropivacaine (150mg) is injected with a Stimuplex A100, 21G needle.

Procedure: Adductor Canal Block

Outcome Measures

Primary Outcome Measures

  1. Morphine consumption in the first 24 hours [24 hours]

    morphine consumption in the first 24 hours (including morphine administered in recovery and via PCA).

Secondary Outcome Measures

  1. Pain Scores [1, 6, 12, 24 hours; up to 48 hours postoperative]

    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.

  2. Morphine Consumption [At 48 hours]

    The balance usage after primary outcome

  3. Postoperative Nausea and Vomiting [Up to 48 hours]

    Presence/absence of nausea and vomiting, and total number of episodes of vomiting

  4. Sedation Scores [Up to 48 hours]

  5. Quadriceps Strength [at 24 and 48 hours]

Other Outcome Measures

  1. Presence of Complications [up to 48 hours]

    Hematoma, wound infection, neurological deficits, any incidence of fall

  2. Length of Hospital Stay [Up to 30 days]

    Number of days till discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changi General Hospital Singapore Singapore

Sponsors and Collaborators

  • Changi General Hospital

Investigators

  • Principal Investigator: Yean Chin Lim, MBBS, Changi General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Changi General Hospital
ClinicalTrials.gov Identifier:
NCT02104934
Other Study ID Numbers:
  • CGHLIAACB2013
First Posted:
Apr 7, 2014
Last Update Posted:
Apr 25, 2017
Last Verified:
Jul 1, 2015
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2017