Rebound pain after volar plate surgery in infraclavicular brachial plexus block with ropivacaine 3.75 mg/ml compared with 7.5 mg/ml. A prospective, triple blinded randomised controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo University Hospital HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

14 Feb 2025 → 8 Apr 2026

Decision date (initial)

2025-01-15

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Oslo University Hospital · University of Oslo

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response

To investigate if severity of postoperative pain may be related to the concentration of ropivacaine.

Secondary objectives 11

1. To clarify if a higher concentration of ropivacaine reduces the incidence of rebound pain.
2. to clarify if ropivacaine concentration have an impact of pain at different time points.
3. To clarify if the concetration of ropivacaine has an impact on the duration of moderate and strong pain.
4. To clarify if ropivacaine concentration influence the worst pain and avarage pain experience at different time points and intervals for the patients.
5. To find out if ropivacaine concentration has an impact on more long-lasting pain.
6. To clarify if ropivacaine concentration has an impact on analgesic consumption after surgery.
7. To clarify whether a higher concentration of ropivacaine results in prolonged sensory and motor block.
8. To try to estimate differences in pain burden with different quality of life measures at different time points.
9. Try to estimate differences in the quality of pain, if persistent pain, at 6 weeks after surgery.
10. Try to estimate differences in satisfaction with the pain treatment.
11. Is there a difference in block success rate between the two concentrations

Conditions and MedDRA coding

Radius fracture

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Adult patients with radius fracture, scheduled for volar plate surgery within 20 days after the fracture trauma
2. ASA I, II and stable ASA III patients
3. Body Mass Index (BMI) 18-40 kg/m2
4. Body weight 50 kg or above
5. Ability to understand and communicate sufficiently in a Scandinavian language
6. Capable of giving signed informed consent

Exclusion criteria 10

1. Progressive neurologic disease
2. Existing long-term pain
3. Peripheral nerve damage in the fractured arm
4. Breast-feeding women or women pregnant on the inclusion day
5. Contraindications for ropivacaine, etoricoxib, dexamethasone, paracetamol or oxycodone
6. Excessive intake of alcohol or illegal drugs
7. Use of opioids, psychotropic drugs or medication with sedative effect on a regular basis prior to fracture trauma.
8. Other painful injuries
9. Skin infection or other contraindications for brachial plexus nerve block
10. Previous allergic reaction to local anaesthetics or etoricoxib, dexamethasone, oxycodone or paracetamol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Worst pain score during the first 48 hours after surgery, as measured by Verbal Numeric Rating Score (VNRS) 0-10

Secondary endpoints 15

1. Rebound pain, defined as VNRS (0-10) equal or above 7 at block resolution
2. Difference in VNRS and Likert scale in the post anesthesia care unit (PACU) 8 hours, 24 hours, 48 hours, 3 days and 7 days after surgery.
3. Duration of moderate pain (VNRS 4 or above) and strong pain (VNRS 7 or above).
4. Average and worst pain score (VNRS) 8-24 hours, 24-48 hours, last 24 hours at 3 days and 7 days after surgery.
5. Pain at rest and with movement at 6 weeks after surgery (VNRS 0-10 and Likert scale)
6. Worst pain last week at 6 weeks after surgery and average pain last 24 hours at 6 weeks after surgery.
7. Total opioid and analgesic consumption first 24 hours, 24-48 hours, 48 hours to 1 week and last week at 6 weeks after surgery.
8. Duration of motoric and sensoric block from peripheral nerve block (needle out).
9. Time from needle out to first rescue analgesic
10. Quality of sleep, work ability, social life and cognitive function the first night, 48 hours, 3 days, 7 days and 6 weeks after surgery (Likert scale).
11. Number of patients answering yes to the question: Do you have bothersome pain?
12. The type of pain experienced 6 weeks after surgery, if persistens pain (heat, cold, burning, prickly, tingling, itchy, squeezing).
13. Satisfaction with pain treatment (yes/no)
14. Sensory and motor test of adequate nerves after peripheral nerve block before surgery and 1 hour after surgery.
15. Was the nerve block adequate for surgery (yes/no)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 8

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation

Oslo University Hospital HF

Address

Taarnbygget, Kirkeveien 166 Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo University Hospital HF

Contact name

Secretary of the Department of Anesthesia and Intensive Care Medicine, Ullevål

Public contact point

Organisation

Oslo University Hospital HF

Contact name

Secretary of the Department of Anesthesia and Intensive Care Medicine, Ullevål

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications