- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07470021
Preop US-Guided Nerve Blocks for Pain & Recovery After Ankle Arthroscopy
Effects of Preoperative Ultrasound-Guided Popliteal Sciatic and Saphenous Nerve Blocks on Early Pain and Functional Recovery After Ankle Arthroscopy: A Randomized, Double-Blind, Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Background
Ankle arthroscopy is often performed in day-case or short-stay settings. Despite the minimally invasive incisions, patients frequently experience significant early postoperative ankle pain, often requiring substantial opioid analgesia, which can lead to notable opioid-related side effects. Currently, there is no standardized perioperative analgesic protocol for this procedure, and high-quality evidence is lacking on whether nerve blocks offer a meaningful net benefit in this context.
This study evaluates the net clinical benefit of preoperative popliteal sciatic and saphenous nerve blocks in ankle arthroscopy by assessing their effect on early postoperative pain control and functional mobility. Outcomes are measured through the highest pain scores within 24 hours and assessments of ambulation ability, aiming to inform clinical decision-making regarding perioperative analgesia strategies.
Hypothesis
Compared to sham blocks, preoperative popliteal sciatic and saphenous nerve blocks significantly reduce the highest postoperative pain scores (NRS 0-10) in the recovery room after ankle arthroscopy, but may also result in reduced ankle motor strength and decreased early ambulation ability.
Surgical and Anesthetic Protocol
All patients receive general anesthesia, maintained with propofol and remifentanil according to body weight. Anesthetic depth is titrated to maintain a BIS value between 40-60 while ensuring hemodynamic stability. A standardized dose of 5 mg of tropisetron is administered postoperatively to prevent PONV.
Postoperative analgesia includes celecoxib 200 mg BID and acetaminophen 500 mg every 6 hours, with oxycodone-acetaminophen (325 mg/5 mg) available as rescue analgesia if needed.
Outcome Measures
Highest NRS pain score within 24 hours postoperatively
Total opioid consumption in the first 24 hours
Average pain score at 24 hours post-op
Patient-reported ankle weakness (NRS 1-10)
Patient satisfaction with postoperative analgesia (4-point Likert scale)
Degrees of ankle plantarflexion and dorsiflexion, and MRC muscle strength grading (0-5), assessed pre-block and at discharge
Total hospital stay duration
Total costs related to anesthesia and analgesia
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: zongyou Pan, Doctoral degree
- Phone Number: 86-19857004757
- Email: panzongyou@gmail.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Recruiting
- The Second Affiliated Hospital Zhejiang University School of Medicine
-
Contact:
- zongyou pan, Doctoral degree
- Phone Number: 0571-87783777
- Email: panzongyou@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age between 18 and 65 years
ASA physical status classification I-II
Scheduled to undergo ankle arthroscopy under general anesthesia
Expected to be available for follow-up on the day of surgery (day-case or short-stay surgery)
Able to understand the procedures and methods of the clinical trial and voluntarily provide written informed consent
Body mass index (BMI) between 16 and 32 kg/m²
Exclusion Criteria:
History of severe ankle nerve injury or peripheral neuropathy
Severe cardiac, pulmonary, hepatic, or renal dysfunction
Chronic pain or regular use of opioid analgesics for more than 3 months
History of extensive ankle or lower leg surgery that may affect nerve localization
Psychiatric disorders or cognitive impairment that preclude accurate NRS pain scoring
Pregnancy or breastfeeding
Known allergy or contraindication to any of the study drugs
Any other condition deemed unsuitable for inclusion by the investigators
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PNB group
Prior to anesthesia induction, patients received nerve blocks in the anesthesia preparation room.
In the prone position, under ultrasound guidance, the anesthesiologist performed a sciatic nerve block with 20 mL and a saphenous nerve block with 10 mL of 0.25% ropivacaine, for a total volume of 30 mL.
The success of the block was assessed by the anesthesiologist based on circumferential spread of the local anesthetic around the target nerves under ultrasound, along with sensory reduction over the dorsum and plantar surface of the foot, the lateral foot, and the area around the Achilles tendon.
|
Ultrasound-guided sciatic (20 mL) and saphenous (10 mL) nerve blocks using 0.25% ropivacaine were administered in the prone position before induction.
Block success was confirmed via ultrasound (circumferential spread) and sensory loss in relevant ankle dermatomes.
|
|
Placebo Comparator: placebo group
In the control group, the procedure was identical, except that an equal volume of 0.9% saline was administered in place of ropivacaine.
|
The control group underwent the same procedure, with an equivalent volume of 0.9% normal saline injected instead of local anesthetic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The patient's highest NRS pain score within 24 hours postoperatively
Time Frame: within 24 hours postoperatively
|
within 24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
NRS pain score at 24 hours postoperatively
Time Frame: at 24 hours postoperatively
|
at 24 hours postoperatively
|
|
Opioid consumption within 24 hours postoperatively (OME)
Time Frame: within 24 hours postoperatively
|
within 24 hours postoperatively
|
|
Patient-reported ankle weakness (0-10 NRS)
Time Frame: Within 24 hours after surgery
|
Within 24 hours after surgery
|
|
Ankle plantarflexion and dorsiflexion angles, as well as manual muscle strength graded by the MRC scale (0-5), were assessed before the nerve block and at the time of discharge.
Time Frame: Within 24 hours after surgery
|
Within 24 hours after surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2026-0051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankle Ligament Injury,Chronic Ankle Instability,Ankle Arthroscopy
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingChronic Ankle Instability | Ankle Ligament Injury | Ankle Arthroscopy
-
Chirurgie Du SportRecruitingSyndesmotic Injury | Ankle Instability | Ankle Ligament Rupture | Ankle (Ligaments); Instability (Old Injury)France
-
Peking University Third HospitalRecruitingChronic Instability of Ankle Joint | Lateral Ligament Complex Injury of AnkleChina
-
University of BolognaCompletedAnkle Injuries | Sport Injury | Ankle Sprains | Instability, Joint | Chronic Instability of Joint | Chronic Instability, Capsular Ligament | Ankle Inversion SprainItaly
-
Hancock OrthopedicsCONMED CorporationRecruitingLateral Ankle Instability | Ankle | Anterior Talofibular Ligament Injury | Anterior Talofibular Ligament | ATFL | Brostrom Procedure | BrostromUnited States
-
Federal University of São PauloRecruitingSurgery | Ligament Injury | Ankle Sprains | Instability, JointBrazil
-
University of SalamancaNot yet recruitingAnkle Equinus | Ankle (Ligaments); Instability (Old Injury) | Ankle DorsiflexionSpain
-
University of UtahBeijing Sport UniversityCompletedChronic Ankle Instability | Chronic Ankle Instability, CAIChina
-
Centre Hospitalier Universitaire de Saint EtienneCompletedAnkle Disease | Ankle (Ligaments); Instability (Old Injury)France
-
St. John's Research InstituteCompletedChronic Ankle Instability | Functional Ankle Instability | Lateral Ankle SprainIndia
Clinical Trials on Ultrasound-guided popliteal sciatic and saphenous nerve block
-
General Hospital of Ningxia Medical UniversityNot yet recruitingAdverse Effect | Safety and Effectiveness | Feasibility StudyChina
-
University of California, San DiegoTerminatedFoot SurgeryUnited States
-
Bispebjerg HospitalCompletedLower Leg Surgery, e.g. Ankle FracturesDenmark
-
General Hospital of Ningxia Medical UniversityRecruiting
-
Ain Shams UniversityCompletedPostoperative Pain | Knee Osteoarthritis | Total Knee ArthroplastyEgypt
-
Asan Medical CenterUnknownPain, Postoperative | Acute Pain | Preemptive Peripheral Nerve BlockKorea, Republic of
-
Ain Shams UniversityCompleted
-
Ain Shams UniversityCompletedSciatic Nerve Block
-
Nordsjaellands HospitalHvidovre University Hospital; Nordstar MedicalNot yet recruitingPrimary Condition: Nerve Block | Secondary Condition: Catheter Displacement | Focus of Study: Sciatic NerveDenmark
-
Gaziosmanpasa Research and Education HospitalCompletedPostoperative Pain | Analgesia | Postoperative Pain Management | Ankle Surgery | Nerve BlocksTurkey (Türkiye)