Clinical trial NCT06230081: Comparison Between Blocks or Not in Joint Arthroplasty
Official title: Postoperative Analgesia in Patients Undergoing Hip and Knee Replacement Surgery - a Study Comparing Ultrasound-guided Nerve Blocks With Intraoperative Local Anesthetic Infiltration or Opioids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis of the Knee or Hip
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients are randomized to either block or no block therapy
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect on postoperative pain, opioid consumption and function by adding a combination of regional blocks with local anaesthetic before total hip- and knee arthroplasty compared to standard pain management strategies.

Detailed description: 400 patients with osteoarthritis of the knee (200) or hip (200) necessitating total hip- or knee replacement are entered into the study. All patients are given a standard protocol of analgesics pre- and postoperatively. Patients are receiving general- or spinal anaesthesia during the surgery. General anaesthesia is conducted using Remifentanil 50ug/ml and Propofol 20 mg/ml utilizing a TCI protocol. The airway is managed by LMA or endotracheal tube. Spinal anaesthesia is conducted using isobaric Bupivacaine (hip) and hyperbaric bupivacaine (knee). Decision regarding type of anaesthesia is following guidelines of our department taking contraindications and patients preference into account.

Patients randomized to the block-group undergoing hip replacement surgery with posterior approach are given och combination of PENG block and Iliohypogastric block using Ropivacain 5 mg/ml with a total dose of 200 mg along with clonidine in a total dose of 75 micrograms. Patients undergoing hip replacement with lateral approach are given a combination of PENG block and LFCN block using Ropivacain 5 mg/ml with a total dose of 125 mg along with clonidine in a total dose of 56,25 micrograms. Patients randomized to the standard pain management strategy undergoing hip replacement surgery are given a combination of opioids, paracetamol and Cox-II inhibitors.

Patients randomized to the block-group undergoing knee replacement surgery are given a combination of iPACK-, genicular-, AFCN-, adductor canal and vastus intermedius block using Ropivacain 5 mg/ml with a total dose of 225 mg along with clonidine in a total dose of 75 micrograms. Patients randomized to the standard pain management strategy undergoing knee replacement surgery are given a perioperative periarticular LIA using Ropivacaine 300 mg along with 0,5 mg of adrenaline.

The randomization is executed on the day before surgery by opening of a closed numbered envelope giving information if the specific patient should have a block (intervention) or not (control). There are 200 prepared envelopes for the hip replacements and 200 for the knee replacements, with 100 blocks and 100 no blocks for each type. The envelopes are prepared by block randomization performed by computer software. Nurses and physiotherapists who evaluate postoperative pain are blinded from the intervention. The physician compiling the data from the study is also blinded to the intervention.

Preoperatively, information is collected regarding doses of analgesics and pain in everyday life is evaluated using the NRS scale. Preoperative pain is evaluated at rest and during mobilization.

Postoperatively, an evaluation of pain is made. After the operation the patients are monitored at the ward by the nurses and physiotherapists. The registration takes place using the subjective Numeric Rating Scale (NRS) and the objective Critical-Care Pain Observation Tool (CPOT). Pain is continuously evaluated during the hospital stay. The final registration takes place at the return visit 14 days after surgery. During the hospital stay, other parameters such as opioid consumption, requirement for urinary catheter, postoperative nausea and vomiting (PONV), time to mobilization and neurological complications are also registered. The number of extra opioid doses the patient requires are also registered. The number of days the patients need to stay in hospital after surgery are registered.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the knee- or hip necessitating total knee- or hip replacement
* Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

Exclusion Criteria:

* Known allergy to local anesthetics or other contraindication for the use of local anesthetics.
* Coagulopathy
* Bilateral operation
* Revision arthroplasty

Primary outcomes:
measure: Difference in Postoperative pain assessed by NRS
timeFrame: The day of surgery, postop day 1 and 14 days post-surgery
Secondary outcomes:
measure: Difference in analgesia consumption
timeFrame: The day of surgery, postop day 1 and 14 days post-surgery
measure: Time to mobilization
timeFrame: The day of surgery, postop day 1
measure: Incidence of postoperative nausea and vomiting
timeFrame: The day of surgery, postop day 1
measure: Difference in postoperative pain depending on method of anesthesia
timeFrame: The day of surgery, postop day 1 and 14 days post-surgery
measure: urine catheter usage
timeFrame: 1-5 days post-surgery
measure: neurological complications
timeFrame: The day of surgery, postop day 1 and 14 days post-surgery
measure: Days in hospital
timeFrame: 1-5 days post-surgery
measure: opioid consumption 14 days
timeFrame: 14 days post-surgery
Other outcomes:
Locations:
city: Trelleborg
country: Sweden
facility: Dept of Anaesthesiology, Trelleborg Hospital
Study officials:
affiliation: Department of Orthopedics, Skane Univ Hosp
name: Gunnar Flivik, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: