Trial no.:	PACTR202306652234255	Date of Approval:	19/06/2023
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

A comparative study between combined adductor canal and infiltration of the interspace between popliteal artery and the capsule of posterior knee blocks versus combined adductor canal and periarticular injection blocks after total knee arthroplasty

Official scientific title

A comparative study between combined adductor canal and infiltration of the interspace between popliteal artery and the capsule of posterior knee blocks versus combined adductor canal and periarticular injection blocks after total knee arthroplasty

Brief summary describing the background and objectives of the trial

Appropriate perioperative pain management results in faster recovery and rehabilitation leading to better functional outcome in patients undergoing TKA. This has necessitated the development of multimodal analgesia regimens involving the use of both regional anesthesia and systemic analgesics. Postoperative pain management after total knee arthroplasty (TKA) continues to evolve with better treatment strategies being formulated to improve patient satisfaction, clinical outcomes and reduce opioid use in the immediate postoperative period. Peripheral nerve blockade has been reported to deliver optimal postoperative pain relief and is increasingly preferred in patients undergoing orthopedic procedures, and various different techniques such as sciatic nerve block, femoral nerve block and adductor canal block have been described Adductor canal block (ACB) and infiltration between the popliteal artery and the posterior capsule of the knee (IPACK) are considered motor sparing peripheral nerve blocks that can be suitable for multimodal analgesic pathways for knee arthroplasty. The objective of this study is to evaluate the efficacy of an IPACK block supplementing ACB block versus ACB and periarticular injection Blocks on postoperative pain scale scores, opioid consumption, performance during early physical therapy in patients undergoing total knee arthroplasty.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Anaesthesia

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

comparing different approaches

Anticipated trial start date

01/06/2023

Actual trial start date

01/06/2023

Anticipated date of last follow up

15/09/2023

Actual Last follow-up date

01/10/2023

Anticipated target sample size (number of participants)

40

Actual target sample size (number of participants)

40

Recruitment status

Completed

Publication URL

not available yet

Secondary Ids	Issuing authority/Trial register

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	Allocation was determined by the holder of the sequence who is situated off site	Masking/blinding used	Care giver/Provider,Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Group A	40 ml	48 hours postoperatively	After finishing the spinal anesthesia while the patient in supine position, ultrasound guided ACB will be performed at the mid-thigh level with high frequency transducer by injecting 20 ml of local anesthetic using 20 G sonoplex needle. After that, the IPACK block will be administered by injecting 20 ml of local anesthetic using the same needle by infiltrating local anesthetic between popliteal artery and posterior capsule of knee while the knee slightly flexed and externally rotated using curved array transducer.	20
Control Group	Group B	40 ml	48 hours	After finishing spinal anesthesia while the patient in supine position, ultrasound guided ACB will be performed at the mid-thigh level with high frequency transducer by injecting 20 ml of local anesthetic using 20 G sonoplex needle. At the end of the operation, PAI of the knee joint will be performed using 20 ml of local anesthetic.	20	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
o Age group: less than 75 years old. o Sex: both sexes. o ASA I, II, III. o Type of anesthesia: Single shot spinal anesthesia.	o Patients’ refusal. o Hypersensitivity to Local anesthetics. o Bleeding tendency. o Local infection at site if injection. o Type of anesthesia: General anesthesia. o ASA IV. o Previous neuropathy on the operative limb	Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	75 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

09/05/2023

Research Ethical Committee at Faculty of Medicine Ain Shams University

Ethics Committee Address
Street address	City	Postal code	Country
38 Abbassia Square, Next to Al-Nour Mosque	cairo	11591	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Pain scores using VAS will be monitored 2 hourly for 24 hours and then 4 hourly for next 24 hours.	post-operative period after total knee arthroplasty
Secondary Outcome	Time for first rescue analgesia and total dose of rescue analgesia during first 48 hours postoperatively.	post-operative period after finishing knee arthroplasty
Secondary Outcome	Assessment of quadriceps muscle weakness by assessing patient’s ability to actively extend the knee and flex the hip.	post-operative period after knee arthroplasty

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Ain Shams University Hospitals.	ELabbassiya	cairo	11591	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Hussein abdelnaser hassan	18 emtidiad ramses, Naser city	Cairo	11522	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	faculty of medicine Ain Shams university	38 Abbassia Square, next to Al Nour Mosque	Abbasya	11517	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Hussein Hassan	hussein.med1@gmail.com	+201011206329	18 Emtdiad Ramsis, Naser city
City	Postal code	Country	Position/Affiliation
cairo	11512	Egypt	Assistant Lecturer in Department of Anesthesia Faculty of Medicine Ain Shams University
Role	Name	Email	Phone	Street address
Public Enquiries	Hany ElZahaby	hanyzahaby@hotmail.com	+201227463000	Faculty of medicine Ain Shams University
City	Postal code	Country	Position/Affiliation
cairo		Egypt	Professor at Anesthesia Department Faculty of Medicine Ain Shams University
Role	Name	Email	Phone	Street address
Scientific Enquiries	Mohamed Awad	Mohsen.Mohamed1983@gmail.com	+201204227780	Fifth Settlement New Cairo
City	Postal code	Country	Position/Affiliation
cairo		Egypt	Lecturer at Anesthesia Department Faculty of Medicine Ain Shams University

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	All of the individual data collected during the trial after deidentification	Study Protocol	following publication	any purpose
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

Pan African Clinical Trials Registry