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Comparison Between Blocks or Not in Joint Arthroplasty

Postoperative Analgesia in Patients Undergoing Hip and Knee Replacement Surgery - a Study Comparing Ultrasound-guided Nerve Blocks With Intraoperative Local Anesthetic Infiltration or Opioids

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06230081
Acronym
BLAST
Enrollment
400
Registered
2024-01-30
Start date
2024-02-01
Completion date
2026-04-26
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee or Hip

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.

Interventions

Drug used in the block

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Nurses and physiotherapists evaluating the patients are blinded as well as the physician compiling the data

Intervention model description

The patients are randomized to either block or no block therapy

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in Postoperative pain assessed by NRSThe day of surgery, postop day 1 and 14 days post-surgeryPatient experienced postop pain assessed by NRS (0-10)

Secondary

MeasureTime frameDescription
Difference in analgesia consumptionThe day of surgery, postop day 1 and 14 days post-surgeryDifference in extra oral- and intravenous analgesia consumption (tablets or injections - in mg)
Time to mobilizationThe day of surgery, postop day 1Difference in time mobilizing to standing after surgery
Incidence of postoperative nausea and vomitingThe day of surgery, postop day 1Difference in postoperative nausea and vomiting (reported frequency)
Difference in postoperative pain depending on method of anesthesiaThe day of surgery, postop day 1 and 14 days post-surgeryDifference in postoperative pain depending on method of anesthesia, i.e. General- or Spinal anesthesia. Assessed by NRS (0-10)
urine catheter usage1-5 days post-surgeryDifference in frequency of urine catheter usage
neurological complicationsThe day of surgery, postop day 1 and 14 days post-surgeryDifference in frequency of neurological complications (reported to and assessed by physiotherapist)
Days in hospital1-5 days post-surgeryNumber of postoperative days in hospital
opioid consumption 14 days14 days post-surgeryDifference in opioid consumption 14 days after surgery

Countries

Sweden

Contacts

PRINCIPAL_INVESTIGATORGunnar Flivik, MD PhD

Department of Orthopedics, Skane Univ Hosp

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026