Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202509575366103 Date of Registration: 11/09/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title SPANK vs IPACK block
Official scientific title Comparison between ultrasound guided (SPANK) block and (IPACK) block adding to adductor canal block for postoperative analgesia after total knee replacement
Brief summary describing the background and objectives of the trial Background and aim: Total knee arthroplasty (TKA) is associated with severe postoperative pain, where adductor canal block (ACB) addresses anterior pain but spares the posterior knee, a significant pain source. The IPACK and SPANK blocks are two motor-sparing techniques designed to manage this posterior pain. We aimed to compare the analgesic efficacy of ultrasound-guided IPACK block versus SPANK block when combined with ACB after TKA.
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 Treatment: Drugs
Anticipated trial start date 09/01/2024
Actual trial start date 09/01/2024
Anticipated date of last follow up 09/01/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
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 Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group S SPANK Group For ACB: 15 ml of 0.25% plain bupivacaine (37.5 mg) + 100 mcg (2 ml) of dexmedetomidine. Total volume for ACB: 17 ml. For SPANK Block: 15 ml of 0.25% plain bupivacaine (37.5 mg). Each block is performed as a single injection. The analgesic effect is expected to last for several hours postoperatively. After the completion of total knee replacement surgery under spinal anesthesia, the following two nerve blocks will be performed under strict aseptic technique and ultrasound guidance (using a GE LOGIQ E series machine): Adductor Canal Block (ACB): A high-frequency linear ultrasound probe will be placed at the mid-thigh to identify the sartorius muscle and the underlying femoral artery within the adductor canal. A 25G echogenic needle will be advanced using an in-plane technique. Correct placement will be confirmed by hydrodissection with 3 ml of saline. The study drug solution (15 ml of 0.25% bupivacaine + 100 mcg dexmedetomidine) will be injected around the saphenous nerve and femoral artery within the canal. SPANK Block: The linear ultrasound probe will be placed sagittally over the junction of the femoral shaft and the medial femoral epicondyle to identify the adductor tubercle. The needle will be guided to position its tip at the bony cortex 1 cm anterior to the peak of the adductor tubercle, avoiding the periosteum and popliteal vessels. After negative aspiration, 15 ml of 0.25% bupivacaine will be injected. 45 Active-Treatment of Control Group
Experimental Group Group I IPACK Group For ACB: 15 ml of 0.25% plain bupivacaine (37.5 mg) + 100 mcg (2 ml) of dexmedetomidine. Total volume for ACB: 17 ml. For IPACK Block: 15 ml of 0.25% plain bupivacaine (37.5 mg). Each block is performed as a single injection. The analgesic effect is expected to last for several hours postoperatively. After the completion of total knee replacement surgery under spinal anesthesia, the following two nerve blocks will be performed under strict aseptic technique and ultrasound guidance (using a GE LOGIQ E series machine): Adductor Canal Block (ACB): (Identical to Group S) Performed as described above with the same drug solution. IPACK Block: A curvilinear ultrasound probe will be placed on the lower third of the medial thigh and moved caudally into the popliteal fossa to identify the popliteal artery. With the knee flexed to 90°, the needle will be advanced using a medial-to-lateral trajectory in-plane with the ultrasound beam. The needle tip will be positioned in the space between the popliteal artery and the posterior capsule of the knee, approximately 2 cm beyond the lateral border of the artery. After negative aspiration, 15 ml of 0.25% bupivacaine will be injected incrementally while withdrawing the needle to cover the target area. 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for elective unilateral total knee replacement surgery. American Society of Anesthesiologists (ASA) physical status I or II. Body Mass Index (BMI) less than 40 kg/m². Ability to understand and use the Visual Analogue Scale (VAS) for pain assessment. Patient provides informed written consent to participate in the study. Patient refusal to participate. Known hypersensitivity or allergy to any drug used in the study protocol (e.g., local anesthetics like bupivacaine, dexmedetomidine, nalbuphine, fentanyl, midazolam). Contraindications to regional anesthesia (spinal block or peripheral nerve blocks), such as: Coagulopathy or bleeding disorders. Infection at the proposed injection site. Severe underlying neurological disease. History of chronic pain disorder requiring regular daily use of narcotic (opioid) medications. Significant psychiatric or cognitive disorder that would impair the ability to participate or report pain scores. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 70 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 09/01/2024 The research ethics committee of faculty of medicine Al azhar university
Ethics Committee Address
Street address City Postal code Country
King Faisal St. Assiut 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of postoperative analgesia. Measured from the time of completion of local anesthetic injection for the nerve blocks until the first patient request for rescue analgesia
Secondary Outcome Postoperative pain intensity at rest. Assessed at arrival in the Post-Anesthesia Care Unit, and at 30 minutes, 1 hour, 4 hours, 8 hours, 12 hours, 18 hours, and 24 hours postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Azhar University Hospital King Faisal St, Assiut Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Eid Awamya, Luxor, Egypt. Luxor Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar University King Faisal St, Assiut Assiut Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Eid Abd Allah ahmedeeid86@gmail.com 201090671787 Awamya, Luxor, Egypt
City Postal code Country Position/Affiliation
Luxor Egypt Assistant lecturer in Anesthesia
Role Name Email Phone Street address
Public Enquiries Osama Helal Ahmed DOCTOR_OSAMA_HELAL@hotmail.com 201223460571 King Faisal St
City Postal code Country Position/Affiliation
Assiut Egypt Professor and head of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abo El enain aboelenainmohamed@gmail.com 201008121985 King Faisal St
City Postal code Country Position/Affiliation
Assiut Egypt Lecturer in Anesthesiology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Study Protocol Beginning 9 months and ending 36 months following article publication. open
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 11/09/2025 PACTR Admin 09 Jan 2024