Trial no.:	PACTR202607476059769	Date of Registration:	22/07/2026
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Dexamethasone vs. Dexmedetomidine in Nerve Blocks for Femoral-Popliteal Bypass Pain Management

Official scientific title

Motor-Sparing Regional Anesthesia for Femoral-Popliteal Bypass Surgery: A Randomized Controlled Trial Comparing Adductor Canal Block combined with Infiltration between the Popliteal Artery and Capsule of the Knee Using Dexamethasone versus Dexmedetomidine as Perineural Adjuvants

Brief summary describing the background and objectives of the trial

Femoral-popliteal bypass surgery for peripheral arterial disease requires effective postoperative pain control. Traditional femoral nerve blocks provide good analgesia but cause quadriceps muscle weakness, delaying ambulation and increasing fall risk. The combination of Adductor Canal Block (ACB) and IPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block offers motor-sparing analgesia, preserving the ability to walk while providing complete lower limb pain coverage. Perineural adjuvants such as dexamethasone and dexmedetomidine can prolong the duration of nerve blocks, but no direct comparison has been made between these two adjuvants in the context of femoral-popliteal bypass surgery, which has different pain characteristics and higher bleeding risk than knee arthroplasty. Primary Objective: To compare total postoperative opioid consumption (intravenous nalbuphine) among three groups. Secondary Objectives: Compare pain intensity at rest and during mobilization (Numeric Rating Scale 0–10) Compare time from block completion to first rescue analgesia request Compare motor-sparing effect (quadriceps strength and ambulation distance) Compare block duration (time to first NRS > 3) Compare safety profiles (bradycardia, hypotension, sedation, PONV, LAST, falls) This randomized, double-blind, controlled trial will enroll 75 patients (25 per group) undergoing elective unilateral femoral-popliteal bypass surgery under spinal anesthesia. Participants will receive either bupivacaine alone (control), bupivacaine with dexamethasone 8 mg total, or bupivacaine with dexmedetomidine 25 μg total, administered via both ACB and IPACK blocks. Outcomes will be assessed throughout hospital stay and at 30-day telephone follow-up.

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

09/07/2026

Actual trial start date

11/07/2026

Anticipated date of last follow up

30/12/2026

Actual Last follow-up date

31/12/2026

Anticipated target sample size (number of participants)

75

Actual target sample size (number of participants)

75

Recruitment status

Active, not recruiting

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	Sealed opaque envelopes	Masking/blinding used	Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Dexmedetomidine	Bupivacaine 0.25% + Dexmedetomidine 12.5 μg per block in both ACB and IPACK blocks	pain level for 24 hour postoperative	participants receive both peripheral nerve blocks (ACB + IPACK) with a total volume of 20 mL per block (40 mL total) with Bupivacaine 0.25% + Dexmedetomidine per block in both ACB and IPACK blocks	25
Experimental Group	Dexamethasone	Bupivacaine 0.25% + Dexamethasone in both ACB and IPACK blocks	pain level for 24 hour postoperative	participants receive both peripheral nerve blocks (ACB + IPACK) with a total volume of 20 mL per block (40 mL total) with Bupivacaine 0.25% + Dexamethasone 4 mg per block in both ACB and IPACK blocks	25
Control Group	No Adjuvant	Bupivacaine 0.25% alone in both ACB and IPACK blocks (20 mL each)	pain level for 24 hour postoperative	participants receive both peripheral nerve blocks (ACB + IPACK) with a total volume of 20 mL per block (40 mL total)	25	Uncontrolled

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Age: Adults aged 40 to 85 years Surgery: Scheduled for elective unilateral femoral-popliteal bypass surgery (either above-knee or below-knee) ASA Status: American Society of Anesthesiologists (ASA) physical status class II or III Consent: Able to provide written informed consent	Contraindications to spinal anesthesia (including coagulopathy, infection at the puncture site, or increased intracranial pressure) Contraindications to peripheral nerve blocks (including infection at the injection site) Known allergy to local anesthetics (bupivacaine), dexamethasone, or dexmedetomidine Chronic opioid use defined as more than 30 mg of oral nalbuphine equivalents daily for more than 3 months Pre-existing quadriceps weakness or peripheral neuropathy Severe hepatic impairment or severe renal impairment Pregnancy or breastfeeding Body mass index (BMI) greater than 40 kg/m²	80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	40 Year(s)	85 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

22/06/2026

Mansoura university faculty of medicine MFM IRB

Ethics Committee Address
Street address	City	Postal code	Country
elgomhuria street	mansoura	7650001	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Total postoperative opioid consumption	Admission to PACU , 2 h , 4h , 6 h ,12, and 24 h postoperative
Secondary Outcome	Time to first rescue analgesia	during first 24 hour postoperative

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
faculty of medicine mansoura university	elgomhuria street	mansoura	7650001	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
faculty of medicine mansoura university	elgomhuria street	mansoura	7650001	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	faculty of medicine mansoura university	elgomhuria street	mansoura	7650001	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	mohamed salama	mohamed_615@mans.edu.eg	+201069940993	gehan street
City	Postal code	Country	Position/Affiliation
mansoura	7650001	Egypt	lecturer of anesthesia and surgical icu faculty of medicine mansoura university
Role	Name	Email	Phone	Street address
Public Enquiries	Amira barakat	amiy10102012@gmail.com	+201021632382	elgomhuria street
City	Postal code	Country	Position/Affiliation
mansoura	7650001	Egypt	lecturer of anesthesia and surgical icu faculty of medicine mansoura university
Role	Name	Email	Phone	Street address
Scientific Enquiries	Abdullah Aldhuwaihy	Dradhuwaihy@gmail.com	+966559948840	Alolaya
City	Postal code	Country	Position/Affiliation
riyadh	12271	Saudi Arabia	college of medicine king saud university

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	De- identified individual participant data for all primary and secondary outcome measures will be made available	Informed Consent Form,Statistical Analysis Plan,Study Protocol	will be available within 1 months of study completion	data access requests will be reviewed by an external independent review panel . requestors will be required to sign a data access agreement
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
Intervention	Intervention List	15/07/2026	As regard reviewer comment		Experimental Group, Dexmedetomidine , Bupivacaine 0.25% + Dexmedetomidine 12.5 μg per block in both ACB and IPACK blocks, pain level for 24 hour postoperative , participants receive both peripheral nerve blocks (ACB + IPACK) with a total volume of 20 mL per block (40 mL total) with Bupivacaine 0.25% + Dexmedetomidine per block in both ACB and IPACK blocks, 25,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	15/07/2026	As regard reviewer comment	Experimental Group, Dexamethasone group, Bupivacaine 0.25% + Dexamethasone in both ACB and IPACK blocks, pain level for 24 hour postoperative , participants receive both peripheral nerve blocks (ACB + IPACK) with a total volume of 20 mL per block (40 mL total) with Bupivacaine 0.25% + Dexamethasone 4 mg per block in both ACB and IPACK blocks, 25,	Experimental Group, Dexamethasone , Bupivacaine 0.25% + Dexamethasone in both ACB and IPACK blocks, pain level for 24 hour postoperative , participants receive both peripheral nerve blocks (ACB + IPACK) with a total volume of 20 mL per block (40 mL total) with Bupivacaine 0.25% + Dexamethasone 4 mg per block in both ACB and IPACK blocks, 25,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	15/07/2026	As regard reviewer comment	Control Group, No Adjuvant group , Bupivacaine 0.25% alone in both ACB and IPACK blocks (20 mL each), pain level for 24 hour postoperative , participants receive both peripheral nerve blocks (ACB + IPACK) with a total volume of 20 mL per block (40 mL total), 25, Uncontrolled	Control Group, No Adjuvant, Bupivacaine 0.25% alone in both ACB and IPACK blocks (20 mL each), pain level for 24 hour postoperative , participants receive both peripheral nerve blocks (ACB + IPACK) with a total volume of 20 mL per block (40 mL total), 25, Uncontrolled

Pan African Clinical Trials Registry