Postoperative Pain Clinical Trial
Official title:
Post Operative Analgesia After Wrist Fracture Surgery Under Regional Anesthesia: Randomized Trial, Open Study, With Evaluation of the Endpoint and Patient Blind (PROBE Design), Evaluating the Equivalence Between Ultrasound-guided Nerve Bloc and Local Infiltration
Distal radial fracture reparations by volar plating are often managed under regional
anaesthesia, but are associated with severe pain when the block ends. Acute post-operative
pain may delay rehabilitation, and even be a risk factor for the development of chronic
pain. The use of opioids and the inevitable opioid-related side effects further decrease
patient satisfaction. A multimodal approach to pain management should include local or
regional analgesia technique when possible. In the case of wrist fractures, two methods are
available: peripheral nerve block by the anaesthesiologist or surgical site local
infiltration by the surgeon with a long-acting local aesthetic. Both techniques are commonly
used for the management of postoperative pain after diverse orthopaedic surgeries.
The purpose of this study was to determine the equivalence between ultrasound-guided
peripheral nerve block and local infiltration by the surgeon for short-term postoperative
analgesia after surgical reparation of isolated closed wrist fractures by volar plating
under regional anaesthesia. The quality of postoperative pain, patient satisfaction and
adverse events were recorded for the first 48 hours following surgery.
Patients were allocated to treatment group according to a computer-generated randomisation
sequence by blocs. Randomization was obtained and all data recorded through an electronic
report form (URC Robert Debre).
Demographic and medical information were obtained in a pre-operative anaesthesia
consultation kept with the rest of the patient's written file.
All interventions were carried out under regional anaesthesia consisting of an
ultrasound-guided axillary block with 25-35 mL of lidocaine 1,5% with epinephrine, targeting
the median, ulnar, radial, musculocutaneous and lateral cutaneous nerves. The analgesic
intervention was realised according to group allocation, at the end of surgery: after skin
closure and before making the cast. To ensure the blinding of the patient, the surgical
sterile drapes were kept until the end of the analgesic intervention
- In the peripheral nerve block group (BN), the anaesthesiologist performed an
ultrasound-guided block of the median and radial nerves at the lower third of the arm.
Each nerve was encircled with 10 mL of ropivacaine 0,475%.
- In the local infiltration group (INF), the surgeon injected 10mL of ropivacaine 0,75%
directly all peri-fracture tissues: fracture site, tendon synovial sheaths hypodermis
and dermis regarding surgical incision.
An operating room or aesthetic nurse timed the duration of realisation of the analgesic
intervention.
The intensity of proximal motor nerve block was recorded before patient discharge from the
post anaesthesia care unit, using a modified Bromage Scale.
In each group the pain management was standardised: in the post anaesthesia care unit (PACU)
the patients received 1g of acetaminophen and 550mg of naproxen (NSAID) as well as 20 mg
omeprazole given orally. This treatment was continued in the orthopaedic ward, every 6 hours
for acetaminophen, 12 hours for naproxen and every day for omeprazole. If the pain score
reached 3/10, rescue medication was given: 10 mg of oral morphine sulphate, available every
6 hours. Upon discharge, the patient was given a prescription with these same medications
for two days and clear instructions on the use of rescue opioids.
The patient was asked to record pain scores at 3, 6, 12, 24, 36 and 48 hours, opioid
consumption, opioid related adverse events, quality of sleep and satisfaction with pain
management on a document intended for this purpose.
The pain scores were recorded using a Numeric Rating scale for pain ranging from 0 (no pain)
to 10 (worst possible pain). Total opioid consumption was assessed in milligrams. Quality of
sleep as well as patient satisfaction with pain management were recorded using a numerical
rating scale ranging from 0 to 10.
Interns or medical practitioners unaware of patient allocation then collected the data. If
the patient was discharged within 2 days, data was recovered by telephone. The anonymized
data was then recorded in the electronic report form. All electronic data was declared to
the CNIL (French National Committee for Data protection and Liberties).
According to our preliminary data, the standard deviation of the mean duration of analgesia
for the first 48 postoperative hours was 108 minutes. We chose to set the equivalence margin
at 90 minutes, as it seemed clinically relevant to describe a difference in duration of
analgesia for the patient. With a risk alpha = 5% and beta = 10% and 10% of patients
expected not assessable, the estimated number of patients to include was 72 (36 in each
group).
As this study aims to show equivalence, a per-protocol analysis will be carried out in first
intention. An intention-to-treat analysis will follow to assess the results' reliability and
treatment's efficiency.
Patient characteristics will be described for the two groups.
The primary study endpoint was the delay between analgesic intervention and occurrence of a
pain score greater than 3/10 during the first 48 postoperative hours. The equivalence margin
of 90 minutes was considered clinically relevant, defining an equivalence interval between
-90 and + 90 minutes. If the confidence interval of the difference in analgesia duration
between the two techniques is included in this interval, the two techniques will be
considered equivalent. On the contrary if the confidence interval of the difference is only
partially included of not included in this interval, we will conclude to non-equivalence.
The secondary end-points will be included in a superiority analysis.
- The mean difference for the duration of realisation of analgesic intervention will be
compared using Student's t-test or a non-parametric test.
- The intensity of proximal motor block assessed by modified Bromage Scale will be
compared using a chi-squared test or Fischer's exact test.
- The number of patients with a numerical pain rating ≤ 3, the number of patients
requiring opioids, the frequency of opioid-related adverse events during the first 48
postoperative hours and the quality of sleep on the first night on a numeric scale from
0 to 10 will be compared using a chi-squared test or Fischer's exact test.
- Total opioid consumption (in milligrams) as well as patient satisfaction with pain
management during the first 48 postoperative hours will be compared using Student's
t-test or a non-parametric test.
- The pain scores recorded at 3, 6, 12, 24, 36 and 48 hours postoperatively will be
described with a graphic analysis and compared using a mixed model reflecting the
repeated measures.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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