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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06086483
Other study ID # 495/2020
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 18, 2020
Est. completion date August 24, 2023

Study information

Verified date October 2023
Source Poznan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized, double-blinded, placebo-controlled trial sought to evaluate the efficacy of the iPACK block with Adductor Canal Block on postoperative pain, functional recovery and NLR and PLR levels.


Description:

The Interspace between the popliteal artery and capsule of the posterior knee, or iPACK block, together with the Adductor Canal block (ACB), has been described and shows promise in providing analgesia to the knee joint. However, the effect of these two blocks on postoperative pain levels, functional recovery, and stress response is uncertain. This study compares a preoperative iPACK and ACB block to Sham blocks before total knee arthroplasty under spinal anesthesia.


Recruitment information / eligibility

Status Completed
Enrollment 361
Est. completion date August 24, 2023
Est. primary completion date July 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Patients > 18 years old undergoing unilateral total knee arthroplasty Exclusion Criteria: - refusal to participate - < 18 yo - Chronic opioid use - localized infection

Study Design


Intervention

Drug:
Ropivacaine 0.2% Injectable Solution
20 mL 0.5% ropivacaine was injected into the PENG block 20 mL 0.5% ropivacaine was injected into the Adductor Canal block
0.9%sodium chloride
20 mL 0.9% sodium chloride was injected into the PENG block 20 mL 0.5% sodium chloride was injected into the Adductor Canal block

Locations

Country Name City State
Poland Poznan University of Medical Sciences Poznan Poznan

Sponsors (1)

Lead Sponsor Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative Numeric Pain Rating Scale Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") 24 hours after surgery
Primary postoperative Numeric Pain Rating Scale et rest Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") 48 hours after surgery
Primary postoperative Numeric Pain Rating Scale et rest Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") 72 hours after surgery
Primary postoperative Numeric Pain Rating Scale et rest Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") 96 hours after surgery
Primary postoperative Numeric Pain Rating Scale during active flexion Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") 48 hours after surgery
Primary postoperative Numeric Pain Rating Scale during active flexion Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") 72 hours after surgery
Primary postoperative Numeric Pain Rating Scale during active flexion Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") 96 hours after surgery
Secondary Postoperative opioid consumption milligrams of intravenous morphine equivalents 96 hours after surgery
Secondary Neutrophil-to-lymphocyte ratio Neutrophil-to-lymphocyte ratio 12 hours after surgery
Secondary Neutrophil-to-lymphocyte ratio Neutrophil-to-lymphocyte ratio 24 hours after surgery
Secondary Platelet-to-lymphocyte ratio Platelet-to-lymphocyte ratio 12 hours after surgery
Secondary Platelet-to-lymphocyte ratio Platelet-to-lymphocyte ratio 24 hours after surgery
Secondary Time to first opioid administration Hours to first administration of an intravenous opioid drug 96 hours postoperatively
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