- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06230081
Comparison Between Blocks or Not in Joint Arthroplasty (BLAST)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Trelleborg, Sweden
- Dept of Anaesthesiology, Trelleborg Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Block
Hip Arthroplasty: Multimodal analgesic therapy + Ultrasound guided PENG block and Iliohypogastric block or LFCN-block. Knee arthroplasty: Multimodal analgesic therapy + Ultrasound guided iPACK block, triple Genicular blocks, Vastus intermedius block, Adductor canal block and AFCN-block. |
Drug used in the block
|
|
No Intervention: No block
Hip Arthroplasty: Multimodal analgesic therapy Knee Arthroplasty: Multimodal analgesic therapy + LIA |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in Postoperative pain assessed by NRS
Time Frame: The day of surgery, postop day 1 and 14 days post-surgery
|
Patient experienced postop pain assessed by NRS (0-10)
|
The day of surgery, postop day 1 and 14 days post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in analgesia consumption
Time Frame: The day of surgery, postop day 1 and 14 days post-surgery
|
Difference in extra oral- and intravenous analgesia consumption (tablets or injections - in mg)
|
The day of surgery, postop day 1 and 14 days post-surgery
|
|
Time to mobilization
Time Frame: The day of surgery, postop day 1
|
Difference in time mobilizing to standing after surgery
|
The day of surgery, postop day 1
|
|
Incidence of postoperative nausea and vomiting
Time Frame: The day of surgery, postop day 1
|
Difference in postoperative nausea and vomiting (reported frequency)
|
The day of surgery, postop day 1
|
|
Difference in postoperative pain depending on method of anesthesia
Time Frame: The day of surgery, postop day 1 and 14 days post-surgery
|
Difference in postoperative pain depending on method of anesthesia, i.e.
General- or Spinal anesthesia.
Assessed by NRS (0-10)
|
The day of surgery, postop day 1 and 14 days post-surgery
|
|
urine catheter usage
Time Frame: 1-5 days post-surgery
|
Difference in frequency of urine catheter usage
|
1-5 days post-surgery
|
|
neurological complications
Time Frame: The day of surgery, postop day 1 and 14 days post-surgery
|
Difference in frequency of neurological complications (reported to and assessed by physiotherapist)
|
The day of surgery, postop day 1 and 14 days post-surgery
|
|
Days in hospital
Time Frame: 1-5 days post-surgery
|
Number of postoperative days in hospital
|
1-5 days post-surgery
|
|
opioid consumption 14 days
Time Frame: 14 days post-surgery
|
Difference in opioid consumption 14 days after surgery
|
14 days post-surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gunnar Flivik, MD PhD, Department of Orthopedics, Skane Univ Hosp
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BLAST study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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