Pain, PostoperativeNCT03683342
Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery
A study testing Ankle Block and Sciatic nerve block in people with Pain, Postoperative, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Pain after forefoot surgery can be important and regional anesthesia plays a crucial role in post-operative pain control. Several techniques can be used to achieve surgical anesthesia as well as postoperative analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ankle Block and Sciatic nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Sep 2018to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are going to undergo a unilateral forefoot surgery ;
- ASA I-III ;
- Aged 18 years or more;
- Weighing at least 45 kg
Who cannot join
- Patient refusal and/or language/cognitive barrier
- Pregnancy
- Contra-indication for regional anesthesia
- Opiate or alcohol dependency
- Concomitant oncological disease with chemotherapy
- Patients suffering from neuropathic pain
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Canton of Vaud, 1011
About this study
Pain after forefoot surgery can be important and regional anesthesia plays a crucial role in post-operative pain control. Several techniques can be used to achieve surgical anesthesia as well as postoperative analgesia. Of those techniques the ankle block and sciatic nerve block at the popliteal fossa are the most common. The primary goal of this study is thus to compare the analgesic duration of these two types of blocks for patients undergoing forefoot surgery.
Read the detailed description
Patients scheduled for unilateral forefoot surgery, aged over 18 years old and ASA status I-III without any contra-indications for regional anesthesia will be enrolled.
After a standard randomisation, patients will be allocated in either of two groups : ankle block or sciatic nerve block at the popliteal fossa. In both groups the patients will have a multimodal analgesic regimen followed by a patient-controlled-analgesia (PCA) of morphine.
The primary endpoint is the analgesic duration, defined by the time between the end of the block procedure and the first IV request of morphine from a PCA.
- Conditions
- Pain, Postoperative
- Being tested
- Ankle Block, Sciatic nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle BlockProcedure or surgery
Ankle block will be performed prior to surgery under ultrasound guidance
Sciatic nerve blockProcedure or surgery
Sciatic nerve block will be performed prior to surgery under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Ankle Block | Active comparator | Ankle block will be performed under ultrasound guidance. Receives: Procedure: Ankle Block |
| Popliteal sciatic nerve block (PSNB) | Active comparator | PSNB will be performed under ultrasound guidance, along with a saphenous nerve block at the ankle Receives: Procedure: Sciatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
Time elapsed between block procedure and first iv request of morphine from PCA
Measured: 24 hours after surgery
Secondary outcomes (13)
Total opioid consumption at 24h postoperatively
Total consumption of morphine from PCA at 24 postoperative hours
Measured: 24 hours after surgery
Pain score at rest at 4 postoperative hours
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Measured: 4 hours after surgery
Pain score on movement at 4 postoperative hours
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Measured: 4 hours after surgery
Pain score at rest at 12 postoperative hours
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Measured: 12 hours after surgery
Pain score on movement at 12 postoperative hours
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Measured: 12 hours after surgery
Pain score at rest at 24 postoperative hours
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Measured: 24 hours after surgery
Pain score on movement at 24 postoperative hours
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Measured: 24 hours after surgery
Block success rate
Success of block assessed by pinprick test
Measured: 45 minutes after block procedure
Global patient satisfaction 48h after surgery
Patient satisfaction score (visual analog scale, 0 = minimum; 10 = maximum)
Measured: 48 hours after surgery
Complications after block
Report of any intravascular injection or any sensory/motor anomalies
Measured: 48 hours after surgery
Rate of neuropathic pain
Rate of patients describing neuropathic pain 4-6 weeks postoperatively
Measured: 4-6 weeks postoperatively
Rate of paresthesia
Rate of patients complaining of paresthesia
Measured: Up to 24 hours after block procedure
Block procedure time
Time from first ultrasound image to needle withdrawal
Measured: Up to 10 minutes after ultrasound scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start20 Sep 2018
- Primary completion1 Nov 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
- Investigators
- Eric Albrecht, PD Dr, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683342
- Sponsor's protocol ID
- CER-VD 2018-01090
- Status last verified
- Aug 2023
- First submitted
- 20 Sep 2018
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olofsson M, Nguyen A, Rossel JB, Albrecht E. Duration of analgesia after forefoot surgery compared between an ankle and a sciatic nerve block at the popliteal crease: A randomised controlled single-blinded trial. Eur J Anaesthesiol. 2024 Jan 1;41(1):55-60. doi: 10.1097/EJA.0000000000001929. Epub 2023 Nov 16.
PubMed 37972929
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery
- ClinicalTrials.gov ID
- NCT03683342
- Acronym / sponsor ID
- CER-VD 2018-01090
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain after forefoot surgery can be important and regional anesthesia plays a crucial role in post-operative pain control. Several techniques can be used to achieve surgical anesthesia as well as postoperative analgesia. Of those techniques the ankle block and sciatic nerve block at the popliteal fossa are the most common. The primary goal of this study is thus to compare the analgesic duration of these two types of blocks for patients undergoing forefoot surgery.
Detailed description
Patients scheduled for unilateral forefoot surgery, aged over 18 years old and ASA status I-III without any contra-indications for regional anesthesia will be enrolled.
After a standard randomisation, patients will be allocated in either of two groups : ankle block or sciatic nerve block at the popliteal fossa. In both groups the patients will have a multimodal analgesic regimen followed by a patient-controlled-analgesia (PCA) of morphine.
The primary endpoint is the analgesic duration, defined by the time between the end of the block procedure and the first IV request of morphine from a PCA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankle Block | Active comparator | Procedure: Ankle BlockAnkle block will be performed under ultrasound guidance. |
| Popliteal sciatic nerve block (PSNB) | Active comparator | Procedure: Sciatic nerve blockPSNB will be performed under ultrasound guidance, along with a saphenous nerve block at the ankle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are going to undergo a unilateral forefoot surgery ;
- ASA I-III ;
- Aged 18 years or more;
- Weighing at least 45 kg
Key exclusion criteria (6 listed)
- Patient refusal and/or language/cognitive barrier
- Pregnancy
- Contra-indication for regional anesthesia
- Opiate or alcohol dependency
- Concomitant oncological disease with chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle BlockAnkle block will be performed prior to surgery under ultrasound guidance | Procedure or surgery | Ankle Block |
| Sciatic nerve blockSciatic nerve block will be performed prior to surgery under ultrasound guidance | Procedure or surgery | Popliteal sciatic nerve block (PSNB) |
Primary outcome
Duration of analgesia
Time frame: 24 hours after surgery
Time elapsed between block procedure and first iv request of morphine from PCA
13 secondary outcomes
Total opioid consumption at 24h postoperatively
Time frame: 24 hours after surgery
Pain score at rest at 4 postoperative hours
Time frame: 4 hours after surgery
Pain score on movement at 4 postoperative hours
Time frame: 4 hours after surgery
Pain score at rest at 12 postoperative hours
Time frame: 12 hours after surgery
Pain score on movement at 12 postoperative hours
Time frame: 12 hours after surgery
Pain score at rest at 24 postoperative hours
Time frame: 24 hours after surgery
Pain score on movement at 24 postoperative hours
Time frame: 24 hours after surgery
Block success rate
Time frame: 45 minutes after block procedure
Global patient satisfaction 48h after surgery
Time frame: 48 hours after surgery
Complications after block
Time frame: 48 hours after surgery
Rate of neuropathic pain
Time frame: 4-6 weeks postoperatively
Rate of paresthesia
Time frame: Up to 24 hours after block procedure
Block procedure time
Time frame: Up to 10 minutes after ultrasound scanning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Derived from this study: PubMed 37972929Olofsson M, Nguyen A, Rossel JB, Albrecht E. Duration of analgesia after forefoot surgery compared between an ankle and a sciatic nerve block at the popliteal crease: A randomised controlled single-blinded trial. Eur J Anaesthesiol. 2024 Jan 1;41(1):55-60. doi: 10.1097/EJA.0000000000001929. Epub 2023 Nov 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Albrecht, PD Dr principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Block and Sciatic nerve block in people with Pain, Postoperative, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesia (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.