Dexmedetomidine-Enhanced PENB Plus SCPB vs Interscalene Block for Arthroscopic Shoulder Surgery
NCT07926295, Not applicable, Not yet recruiting, Beni-Suef University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Dexmedetomidine-Enhanced PENB Plus SCPB vs Interscalene Block for Arthroscopic Shoulder Surgery | ClinicalTrials.gov |
| NCT number | NCT07926295 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beni-Suef University | ClinicalTrials.gov |
| Conditions | Postoperative Pain, Diaphragmatic Paralysis, Shoulder Arthroscopic Surgery | ClinicalTrials.gov |
| Interventions | Bupivacaine, Dexmedetomidine, Interscalene Brachial Plexus Block, Pericapsular Nerve Block plus Superficial Cervical Plexus Block | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cumulative Fentanyl Consumption at 24 Hours | 24 hours postoperatively | Cumulative dose of intravenous rescue fentanyl (in micrograms) administered over the first 24 postoperative hours for pain scores (Numerical Rating Scale \> 3). Non-inferiority margin is pre-specified at 45 µg. A lower value indicates a better outcome (less pain/reduced opioid requirement). | ClinicalTrials.gov |
| Primary | Incidence of Hemidiaphragmatic Paralysis at 2 Hours | 2 hours postoperatively | Percentage of participants with diaphragmatic paralysis assessed via ultrasound M-mode excursion during deep inspiration (sniff/sigh maneuvers). Complete paralysis is defined as \>75% reduction in excursion, paradoxical movement, or immobility; partial paralysis is 25-75% reduction. Reported as the percentage of patients with partial or complete paralysis. A lower percentage indicates a better outcome (greater diaphragm preservation). | ClinicalTrials.gov |
| Secondary | Postoperative Pain Intensity Scores From 0 to 72 Hours | Post-anesthesia care unit (PACU) arrival, and at 2, 4, 6, 12, 18, 24, 48, and 72 hours postoperatively | Pain intensity assessed using the 11-point Numerical Rating Scale (NRS), where 0 represents "no pain" and 10 represents "worst imaginable pain". Assessed at rest and movement across scheduled post-op time points. Lower scores indicate a better outcome (less pain). | ClinicalTrials.gov |
| Secondary | Time to First Request for Rescue Analgesia | Up to 72 hours postoperatively | Time elapsed (in minutes) from completion of block placement until the patient's first request for IV rescue fentanyl (NRS \> 3). A higher duration (longer time) indicates a better outcome (prolonged analgesic effect). | ClinicalTrials.gov |
| Secondary | Total 72-Hour Cumulative Opioid Consumption | 72 hours postoperatively | Total cumulative postoperative opioid consumption converted to oral Morphine Milligram Equivalents (MME) over 72 hours. A lower total value indicates a better outcome (reduced overall opioid exposure). | ClinicalTrials.gov |
| Secondary | Quality of Recovery Score (QoR-15) at 24, 48, and 72 Hours | Preoperatively (baseline), and at 24, 48, and 72 hours postoperatively | Validated 15-item patient-reported questionnaire evaluating health status after surgery. Total score ranges from 0 to 150, where higher scores indicate a better outcome (superior overall quality of recovery). | ClinicalTrials.gov |
| Secondary | Patient Satisfaction Score at 24 Hours | 24 hours postoperatively | Patient satisfaction measured on a 5-point Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied). Higher scores indicate a better outcome (greater patient satisfaction). | ClinicalTrials.gov |
| Secondary | Incidence of Block-Related and Anesthesia Complications | Up to 72 hours postoperatively | Number of participants experiencing adverse events including Horner syndrome, hoarseness, vascular puncture, nausea/vomiting, bradycardia (\<50 bpm), hypotension, or respiratory depression. A lower incidence/count indicates a better outcome (greater clinical safety). | ClinicalTrials.gov |
| Secondary | Length of PACU Stay and Time to Discharge Readiness | Up to 24 hours postoperatively | Duration of PACU stay (in minutes) and time to meeting standardized discharge criteria (modified Aldrete score ≥ 9). Lower time durations indicate a better outcome (faster recovery and earlier discharge readiness). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)