Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-29 @ 9:51 PM
Study NCT ID:
NCT07131657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ropiclobet for Regional Anesthesia and Post-Operative Pain Control in Upper Extremity Surgery
Sponsor:
PHARMAFINA
Organization:
Study Overview
Official Title:
A Phase II, Single Arm, Open-label, Three-dose Group Study to Evaluate the Efficacy and Safety of Ropivacaine-betamethasone-clonidine (Ropiclobet) Injectable Solution for Regional Anesthesia and Post-operative Pain Control in Patients Undergoing Upper Extremity Surgery Below Shoulder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a national, single-center, single-arm, open-label Phase II clinical trial designed to evaluate the efficacy and safety of Ropiclobet, a fixed-dose injectable solution containing Ropivacaine HCl, Betamethasone Sodium Phosphate, and Clonidine HCl.
The study includes three non-randomized dose groups and will enroll a total of 60 adult volunteers undergoing upper extremity surgery (arm, elbow, forearm, or hand). All participants will receive a single administration of Ropiclobet via supraclavicular brachial plexus block (SCB) under ultrasound guidance. Sedation may be provided if necessary; however, participants requiring general anesthesia will be excluded from the study.
Postoperatively, volunteers will be monitored in the PACU for 2 hours, followed by transfer to a regular hospital ward under anesthesiology supervision. All participants will remain under clinical observation for 48 hours following the procedure. If the sensory or motor block persists beyond this period, monitoring will continue until full resolution and an additional 6 hours of observation will be provided. Follow-up visits are scheduled for Day 15 and Day 30 post-procedure.
The primary efficacy endpoint is the duration of analgesia and the primary safety endpoint is the incidence and characterization of all adverse events occurring during the procedure and within 30 days postoperatively.
The study includes three non-randomized dose groups and will enroll a total of 60 adult volunteers undergoing upper extremity surgery (arm, elbow, forearm, or hand). All participants will receive a single administration of Ropiclobet via supraclavicular brachial plexus block (SCB) under ultrasound guidance. Sedation may be provided if necessary; however, participants requiring general anesthesia will be excluded from the study.
Postoperatively, volunteers will be monitored in the PACU for 2 hours, followed by transfer to a regular hospital ward under anesthesiology supervision. All participants will remain under clinical observation for 48 hours following the procedure. If the sensory or motor block persists beyond this period, monitoring will continue until full resolution and an additional 6 hours of observation will be provided. Follow-up visits are scheduled for Day 15 and Day 30 post-procedure.
The primary efficacy endpoint is the duration of analgesia and the primary safety endpoint is the incidence and characterization of all adverse events occurring during the procedure and within 30 days postoperatively.
Detailed Description:
This national, single-center, single-arm, open-label Phase II clinical trial includes three dose groups and aims to evaluate the efficacy and safety of Ropiclobet. Ropiclobet Injectable Solution is a fixed-dose combination containing Ropivacaine HCl, Betamethasone Sodium Phosphate, and Clonidine HCl at concentrations of 5.0/0.4\*/0.015 mg/mL (\*the 10 mL ampoule contains 0.53 mg of betamethasone sodium phosphate, equivalent to 0.4 mg of betamethasone).
A total of 60 volunteers (Hospitalized patients in the orthopedic department or outpatients who are scheduled for surgery) undergoing upper extremity surgery (including arm, elbow, forearm, and hand surgeries) will receive a single administration of the Ropiclobet combination via supraclavicular brachial nerve blockade (SCB) under ultrasound guidance.
The study will include three dose groups:
* Group I: 10 mL Ropiclobet combination (1 ampoule) diluted with 10 mL of 0.9% isotonic saline
* Group II: 15 mL Ropiclobet combination (1.5 ampoules) diluted with 5 mL of 0.9% isotonic saline
* Group III: 20 mL Ropiclobet combination (2 ampoules), administered undiluted. There will be no randomization for dose groups. The first 20 participants will be assigned to Group I. The study team will assess safety and efficacy parameters in these participants. Following the completion of 20 participants in Group I, the study will proceed to Group II. Group III will follow in the same manner, with 20 participants planned per group.
Ropiclobet injection will be performed preoperatively under sterile conditions by an experienced anesthesiologist. Only sedation may be administered if needed, and volunteers requiring general anesthesia will be withdrawn from the study.
Standard monitoring will include ECG, non-invasive blood pressure measurement, and pulse oximetry. Postoperatively, volunteers will be monitored in the PACU for 2 hours, followed by observation in the hospital ward under an anesthesiologist's supervision. Volunteers will remain under clinical observation for 48 hours post-procedure. If motor or sensory blockade persists beyond this period, monitoring will continue until full resolution plus an additional 6 hours. Follow-up visits will be at Day 15 and Day 30.
A total of 60 volunteers (Hospitalized patients in the orthopedic department or outpatients who are scheduled for surgery) undergoing upper extremity surgery (including arm, elbow, forearm, and hand surgeries) will receive a single administration of the Ropiclobet combination via supraclavicular brachial nerve blockade (SCB) under ultrasound guidance.
The study will include three dose groups:
* Group I: 10 mL Ropiclobet combination (1 ampoule) diluted with 10 mL of 0.9% isotonic saline
* Group II: 15 mL Ropiclobet combination (1.5 ampoules) diluted with 5 mL of 0.9% isotonic saline
* Group III: 20 mL Ropiclobet combination (2 ampoules), administered undiluted. There will be no randomization for dose groups. The first 20 participants will be assigned to Group I. The study team will assess safety and efficacy parameters in these participants. Following the completion of 20 participants in Group I, the study will proceed to Group II. Group III will follow in the same manner, with 20 participants planned per group.
Ropiclobet injection will be performed preoperatively under sterile conditions by an experienced anesthesiologist. Only sedation may be administered if needed, and volunteers requiring general anesthesia will be withdrawn from the study.
Standard monitoring will include ECG, non-invasive blood pressure measurement, and pulse oximetry. Postoperatively, volunteers will be monitored in the PACU for 2 hours, followed by observation in the hospital ward under an anesthesiologist's supervision. Volunteers will remain under clinical observation for 48 hours post-procedure. If motor or sensory blockade persists beyond this period, monitoring will continue until full resolution plus an additional 6 hours. Follow-up visits will be at Day 15 and Day 30.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: