Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201812776434860 Date of Approval: 12/12/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The interspace between the popliteal artery and the posterior capsule of the knee (IPACK) block
Official scientific title The interspace between the popliteal artery and the posterior capsule of the knee (IPACK) block as a supplement to adductor canal block for postoperative analgesia in total knee arthroplasty; a prospective randomized trial
Brief summary describing the background and objectives of the trial Optimal pain control after total knee arthroplasty (TKA) is important to decrease complications and enable patient to participate in physical therapy and facilitate rapid recovery.1,2 Multimodal analgesia, including regional anesthesia, has attracted significant focus for its ability to improve pain control and reduce opioid-related side effects after TKA.3 Effective pain control after TKA is challenging, as the operative procedure often affects 2 main innervations to the knee: (1) the femoral nerve, which innervates the anterior and, to a lesser degree, the medial aspects of the knee and (2) the sciatic nerve, which innervates the posterior aspects of the knee.4,5 Despite continuous femoral nerve catheter (FNC) block revealed excellent postoperative analgesia and decreased opioid consumption,3,6 patients often encounter a significant degree of quadriceps weakness that limits their participation in early physical rehabilitation.7-9 The adductor canal block (ACB) has been reported to provide similar analgesia to a single-shot FNC block and to allow improved postoperative physical therapy.10 However, patients who undergo TKA and receive an FNC block or ACB frequently encounter postoperative posterior knee pain requiring supplemental opioid medications.11,12 The sciatic nerve block has been shown to improve analgesia and reduce opioid consumption when combined with the FNC block,13 but a sciatic nerve block can lead to sensory and motor deficits below the knee and may increase the risk of falls.3 Therefore, an ideal regional anesthetic technique would include a regional block that provides analgesia to the posterior knee but does not cause distal neurologic deficits. An ultrasound guided local anesthetic infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) 14 provides effective posterior knee analgesia by targeting only the terminal branches of the sciatic nerve without affecting the motor function including common
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative analgesia in total knee arthroplasty
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/12/2018
Actual trial start date 08/01/2019
Anticipated date of last follow up 15/06/2019
Actual Last follow-up date 07/05/2020
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
32653 Tanta University Faculty of Medicine Research Ethics Committee Quality Assurance Unit
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Adductor canal block 20 ml 0.25% plain bupivacaine single shot adductor canal block 40 Active-Treatment of Control Group
Experimental Group IPACK block IPACK block using 15 ml 0.25% plain bupivacaine plus adductor canal block using 20 ml 0.25% plain bupivacaine single shot combined IPACK block and adductor canal block 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
50-80 years either gender ASA I-III undergoing unilateral primary TKA body mass index (BMI) more than 40 renal or hepatic insufficiency localized infection at the site of regional anesthetic intervention allergy to local anesthetic chronic opioid use pre-existing lower extremity neurological deficit patient refusal 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/10/2018 Tanta University Faculty of Medicine Research Ethics Committee Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
Algeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome total 24 h postoperative rescue morphine consumption. once at 24 h postoperative
Secondary Outcome Resting and Motion (knee flexion to 45°) VAS score 4, 6, 12, and 24 hours postoperatively.
Secondary Outcome Time to the 1st rescue administration. at time of 1st request of rescue analgesia
Secondary Outcome The quadriceps muscle power at 12h and 24 h after performing the block
Secondary Outcome • Mobilization ability using the Timed-Up-and-Go (TUG) test. at 12 h and 24 h after performing the block.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Algeish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of anesthesia and surgical ICU Tanta University Hospital Algeish street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Faculty of Medicine Algeish street Tanta Egypt University
Secondary Sponsor Department of anesthesia and surgical ICU Tanta University Hospital Algeish street Tanta Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohammed Ali Abdullah 20 Stad street Tanta Egypt
Mohamed Mohye Eldin Abu Elyazed 55 Stad street Tanta Egypt
Shaimaa Farouk 1 Moheb street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Abdullah moh_aly_2005@hotmail.com +201099957971 20 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of anesthesia and surgical ICU Tanta University Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk shaimaafarouk7777@yahoo.com +201270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and surgical ICU Tanta University Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin mohd_yazed75@yahoo.com +201099707168 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of anesthesia and surgical ICU Tanta University Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information