--- title: Comparison Between Fentanyl and Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block for Postoperative Analgesia After Knee Surgeries nct_id: NCT06759116 overall_status: RECRUITING phase: NA sponsor: Zagazig University study_type: INTERVENTIONAL primary_condition: Analgesia, Postoperative countries: Egypt canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06759116.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06759116" ct_last_update_post_date: 2025-01-14 last_seen_at: "2026-05-12T06:40:11.384Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Comparison Between Fentanyl and Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block for Postoperative Analgesia After Knee Surgeries **Official Title:** Analgesic Effect of Fentanyl Vs Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block After Knee Surgeries **NCT ID:** [NCT06759116](https://clinicaltrials.gov/study/NCT06759116) ## Key Facts - **Status:** RECRUITING - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 111 - **Lead Sponsor:** Zagazig University - **Conditions:** Analgesia, Postoperative - **Start Date:** 2025-01-10 - **Completion Date:** 2025-08-10 - **CT.gov Last Update:** 2025-01-14 ## Brief Summary This study will be undertaken to compare the analgesic effects of of fentanyl versus dexmedetomidine as adjuvant to bupivacaine in combined IPACK and ACB for pain management after total knee arthroplasty. ## Detailed Description * To measure the total amount of rescue analgesic consumption in the first 48 hours post-operatively in each group * To assess pain score in each group by using Numerical Rating Scale (NRS) at rest (static) and during flexion or extension of knee (dynamic) at different time points: PACU, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs. * To measure the time of first request of rescue analgesia in each group * To record the incidence of adverse events (hematoma, local anesthetic toxicity, infection, nausea and vomiting) and length of hospital stay. * Over all patients' satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia). ## Eligibility - **Minimum age:** 21 Years - **Maximum age:** 85 Years - **Sex:** ALL - **Healthy Volunteers:** Yes ``` Inclusion Criteria: 1 - Patient acceptance 2. Cooperative patients 3. Age: ≥21 and 85\< years' old 4. Sex: both sexes (males or females). 5. Physical status: ASA Ι \& II\& Ш. 6. Body Mass Index (BMI): ≤ 35 kg/m2. 7. Type of operation: elective unilateral knee surgeries (TKA, ACL, knee arthroscopy) Exclusion Criteria: . Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site) 2. Patients with known history of allergy to the study drugs (bupivacaine, dexmedetomidine and fentanyl). 3\. Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases. 4.Chronic opioid use (more than 3 months or daily oral morphine \> 5 mg /day for 1 month) \- ``` ## Arms - **Control group (group C)** (ACTIVE_COMPARATOR) — The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ml saline) - **Fentanyl group (group F)** (ACTIVE_COMPARATOR) — The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 50 mcg fentanyl) - **Dexmedetomidine group (group D)** (ACTIVE_COMPARATOR) — The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ug/kg dexmedetomidine not exceeding 100 ug (to be completed to 1mL with normal saline if needed). ) ## Interventions - **Control group** (PROCEDURE) — The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ml saline) - **Fentanyl group** (PROCEDURE) — The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 50 mcg fentanyl) - **Dexmedetomidine group** (PROCEDURE) — The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ug/kg dexmedetomidine not exceeding 100 ug (to be completed to 1mL with normal saline if needed). ) ## Primary Outcomes - **● The total amount of rescue analgesic consumption (tramadol)** _(time frame: For 48 hrs)_ — ● The total amount of rescue analgesic consumption (tramadol) postoperatively in each group - **Pain intensity by using Numerical Rating Scale (NRS) at rest (static) and during flexion or extension of knee (dynamic) at different time points** _(time frame: 0 hours (basal) ( on arrival to PACU), 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs)_ — NRS is 10 cm line numbered from 0 to 10, patients instructed to circle the number that represents his/her pain intensity (0=no pain and 10=maximum pain) ## Secondary Outcomes - **The time to first request of rescue analgesia (tramadol)** _(time frame: 24 hours postoperative)_ - **The length of hospital stays** _(time frame: For 48-72 hrs)_ - **The incidence of adverse events** _(time frame: For 48 hrs)_ - **patient's satisfaction** _(time frame: For 48 hrs)_ ## Locations (1) - faculty of human medicine, Zagazig university hospitals, El Sharkia, Egypt — _RECRUITING_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.faculty of human medicine, zagazig university hospitals|el sharkia||egypt` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06759116.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06759116* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*