To assess whether patients receiving simple hallux valgus surgery ambulate independently earlier after spinal anesthesia combined with LIA, compared to popliteal blocks. We hypothesize that both groups will demonstrate sufficient pain relief.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to ambulate independently after surgery. Independent ambulation is defined
by the ability to walk without the assistance of another person or crutches.
Secondary outcome
1. Post-operative pain as indicated by the patient. NRS pain was collected at
standard times: return to ward, and at 7.00, 12.00, 17.00, 22.00.
2. Patient satisfaction was surveyed using a paper questionnaire prior to
discharge the next day.
Background summary
Hallux valgus correction is a common orthopaedic procedure and suitable for day
surgery (Maher 2009, Mouton 2015). Adequate pain relief and early mobilization
are important, but the optimal peri- and postoperative anesthesia technique to
accommodate outpatient hallux valgus surgery remains a challenge (Adam 2012).
Locoregional blocks have proven to cause durable anesthesia, depending on type
of anesthetic used (Grosser 2007, Kullenberg 2006). However, a prolonged time
of analgesia also results in prolonged absence of motor control impeding
independent ambulation (Adam 2012). Spinal anesthesia is quick and reliable,
but may not give enough pain relief in the first 24 hrs post-surgery (Clough
2003). Local infiltration anesthesia (LIA) has successfully decreased
post-operative pain in total knee arthroplasty, facilitating early mobilization
and reducing the need for additional oral analgesics. In hallux valgus surgery,
the local field block has shown to be an efficacious LIA technique (Gerbert
1996, Adam 2012). It involves infiltration of local anesthetic through all
tissues proximal to the surgical site in a ring block fashion. There is limited
evidence that shows that LIA can cause durable anesthesia and facilitate safe
early mobilization in day care percutaneous hallux valgus surgery (Adam 2012).
Although prolonging the time to first perceived pain, local foot blocks do not
necessarily improve patient satisfaction in the outpatient setting (Clough
2003).
Here, we compare the popliteal nerve block versus combined spinal and local
infiltration anesthesia in a prospective randomized controlled trial. Early
mobility, pain relief and patient satisfaction after hallux valgus surgery were
assessed in a short stay clinicial setting.
Study objective
To assess whether patients receiving simple hallux valgus surgery ambulate
independently earlier after spinal anesthesia combined with LIA, compared to
popliteal blocks. We hypothesize that both groups will demonstrate sufficient
pain relief.
Study design
Clinical randomized controlled prospective trial in a short-stay setting
Intervention
Popliteal anesthesia versus a combination of spinal anesthesia and local
infiltration anesthesia.
Study burden and risks
Patient burden is limited to a paper questionnaire.
There are no benefits for participating patients.
Risks are limited to standard procedure related risks depending on anesthesia
technique in both groups.
Weg door Jonkerbosch 100
Nijmegen 6532SZ
NL
Weg door Jonkerbosch 100
Nijmegen 6532SZ
NL
Listed location countries
Age
Inclusion criteria
- Indication for Chevron ± Akin technique
- Age 18 * 75 yr
- ASA I * II
Exclusion criteria
- Standard contraindications for hallux valgus surgery
- Impaired mobility due to other causes than hallux valgus.
- Previous surgery on the ipsilateral foot.
- Spinal malformation.
- Patients demanding general anesthesia or day care surgery
- Patients using pain medication prior to surgery.
- Inability to understand or correctly interpret the questionnaire (mental retardation, language barrier)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2017-001441-27-NL |
CCMO | NL61454.091.17 |