Phantom Limb PainPhase 3AmpupainNCT05608733
Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Postoperative Pain
A Phase 3 study testing Epidural catheter and Continuous sciatic nerve block in people with Phantom Limb Pain and Pain, Chronic, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain, Pain, Chronic
- What is being tested?
- Epidural catheter and Continuous sciatic nerve block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteColombia
- Study dates
- Dec 2022to Jul 2025
- Phase
- Phase 3
- 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
- Age over 18 years
- Being scheduled for above or below knee amputation or for bone remodeling of lower limb amputees
- Acceptance of continuous regional analgesic technique as part of their multimodal analgesia
Who cannot join
- Traumatic cause of amputation
- Allergy to local anesthetics
- Contraindication for epidural technique or continuous blocks
- Stage 5 kidney disease
- Concomitant use of aspirin and clopidogrel
- Pregnancy status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Prevention of Acute Postoperative Pain and Phantom Limb Pain: A Triple-blind Randomized Controlled Non-inferiority Clinical Trial.
Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants
Read the detailed description
Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants Outcomes: Primary: Numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain) was used for pain assessments daily for 15 days and subsequently monthly until completing 3 months. Co-primary: Assessment of symptomatology related to phantom limb pain daily for 15 days POP and subsequently monthly until completing 3 months.
- Conditions
- Phantom Limb Pain, Pain, Chronic
- Being tested
- Epidural catheter, Continuous sciatic nerve block
- Medical subject headings
- Phantom Limb, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural catheterDrug
Also called Epidural Analgesia
Bony landmarks and the space between the lower lumbar vertebrae are identified. Subsequently, infiltration of the skin and subcutaneous cellular tissue with local anesthetic (Lidocaine 2% without epinephrine) is performed at the site to be punctured. A 17G Tuohy needle is inserted 2-4 cm through the skin, then the mandrel is removed, the low-resistance syringe is connected, and the loss of resistance is checked using the air or liquid technique, depending on the preference of the anesthesiologist. . Appreciating the loss of resistance in the embolus, the mandrel is then withdrawn and the epidural catheter is advanced to leave it an additional 5 cm inside the epidural space.
Continuous sciatic nerve blockDrug
Also called Periferical continuous block
The patient is placed in the prone or supine position with the limb to be blocked flexed at 90°. Using a high-frequency linear transducer and using sterile technique, the popliteal sciatic nerve is identified in an axial axis. A 17G Tuohy needle is inserted plane and medial. Saline solution (5 ml) is applied to open the perineural space. Adequate hydrodissection and donut sign in the nerve are observed..A perineural catheter is then advanced 5 cm beyond the tip of the needle. The catheter is fixed with stitches and a transparent sterile dressing is placed.
| Study group | Role | What they receive |
|---|---|---|
| Epidural catheter | Experimental | Epidural catheter infusion of bupivacaine 0.1% (4-6 cc/h) at level L3-L4 Receives: Drug: Epidural catheter |
| Continuous sciatic nerve block | Active comparator | Continuous sciatic catheter infusion of bupivacaine 0.1% (6-10 cc/h) Receives: Drug: Continuous sciatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posoperative Pain
Pain score according to the daily NRS scale (Numeric Pain Rating Scale), Numeric Pain Rating Scale, for 15 days POP and subsequently monthly until completing 3 months. is scores from 0 to 10, 10 being the worst value.
Measured: 3 months
Phantom Limp Pain
For this qualitative dichotomous outcome, you will ask about symptomatology referring to phantom limb pain for 15 days POP and subsequently monthly until completing 3 months, It will be qualified as positive if it presents any neuropathic symptom.
Measured: 3 months
Secondary outcomes (6)
Phantom Limp Pain first Year
Presence of phantom limb pain on a monthly basis until completing 12 month, The patient will be asked about the appearance of any painful sensation described as stabbing, shooting, electric shock, dull, tight pain and/or cramp in the anatomical site where the amputated limb would be, evaluating the presence or absence of the same (s). This will be questioned every day for 15 POPs days and monthly follow-up will continue via telephone until completing 3 months.
Measured: 1 year
Opioid Consumption
the total consumption in mg of morphine or its equivalent at 12, 24 and 36 h POP will be evaluated.
Measured: 36 hours
Incidence of nausea and vomiting POP
Incidence of nausea and vomiting POP in each group: the appearance of nausea or vomiting at 12, 24 and 36 h POP will be asked.
Measured: 36 hours
Incidence of adverse effects
any appearance of hematoma, hypotension (defined as SBP less than 90 mmHg or a 30% decrease in baseline MAP) or bradycardia (HR less than 60 bpm) is defined.
Measured: 1 year
Days of hospital stay
Days of hospital stay through study completion
Measured: during the time of hospitalization, on average 10 days
Mortality
Mortality in the first Year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Zamudio, Prof, Study director, IPS universitaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608733
- Sponsor's protocol ID
- IN-47-2021
- Acronym
- Ampupain
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: public bases of data
Publications
Edgley C, Hogg M, De Silva A, Braat S, Bucknill A, Leslie K. Severe acute pain and persistent post-surgical pain in orthopaedic trauma patients: a cohort study. Br J Anaesth. 2019 Sep;123(3):350-359. doi: 10.1016/j.bja.2019.05.030. Epub 2019 Jun 24.
PubMed 31248645De Jong R, Shysh AJ. Development of a Multimodal Analgesia Protocol for Perioperative Acute Pain Management for Lower Limb Amputation. Pain Res Manag. 2018 Jun 3;2018:5237040. doi: 10.1155/2018/5237040. eCollection 2018.
PubMed 29973967Gehling M, Tryba M. [Prophylaxis of phantom pain: is regional analgesia ineffective?]. Schmerz. 2003 Jan;17(1):11-9. doi: 10.1007/s00482-002-0198-2. German.
PubMed 12579385
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Prevention of Acute Postoperative Pain and Phantom Limb Pain: A Triple-blind Randomized Controlled Non-inferiority Clinical Trial.
- ClinicalTrials.gov ID
- NCT05608733
- Acronym / sponsor ID
- Ampupain / IN-47-2021
- Conditions
- Phantom Limb Pain, Pain, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 8 Nov 2022 (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.
Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants
Detailed description
Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants Outcomes: Primary: Numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain) was used for pain assessments daily for 15 days and subsequently monthly until completing 3 months. Co-primary: Assessment of symptomatology related to phantom limb pain daily for 15 days POP and subsequently monthly until completing 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural catheter | Experimental | Drug: Epidural catheterEpidural catheter infusion of bupivacaine 0.1% (4-6 cc/h) at level L3-L4 |
| Continuous sciatic nerve block | Active comparator | Drug: Continuous sciatic nerve blockContinuous sciatic catheter infusion of bupivacaine 0.1% (6-10 cc/h) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years
- Being scheduled for above or below knee amputation or for bone remodeling of lower limb amputees
- Acceptance of continuous regional analgesic technique as part of their multimodal analgesia
Key exclusion criteria (6 listed)
- Traumatic cause of amputation
- Allergy to local anesthetics
- Contraindication for epidural technique or continuous blocks
- Stage 5 kidney disease
- Concomitant use of aspirin and clopidogrel
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 |
|---|---|---|
| Epidural catheterAlso: Epidural AnalgesiaBony landmarks and the space between the lower lumbar vertebrae are identified. Subsequently, infiltration of the skin and subcutaneous cellular tissue with local anesthetic (Lidocaine 2% without epinephrine) is performed at the site to be punctured. A 17G Tuohy needle is inserted 2-4 cm through the skin, then the mandrel is removed, the low-resistance syringe is connected, and the loss of resistance is checked using the air or liquid technique, depending on the preference of the anesthesiologist. . Appreciating the loss of resistance in the embolus, the mandrel is then withdrawn and the epidural catheter is advanced to leave it an additional 5 cm inside the epidural space. | Drug | Epidural catheter |
| Continuous sciatic nerve blockAlso: Periferical continuous blockThe patient is placed in the prone or supine position with the limb to be blocked flexed at 90°. Using a high-frequency linear transducer and using sterile technique, the popliteal sciatic nerve is identified in an axial axis. A 17G Tuohy needle is inserted plane and medial. Saline solution (5 ml) is applied to open the perineural space. Adequate hydrodissection and donut sign in the nerve are observed..A perineural catheter is then advanced 5 cm beyond the tip of the needle. The catheter is fixed with stitches and a transparent sterile dressing is placed. | Drug | Continuous sciatic nerve block |
Primary outcome
Posoperative Pain
Time frame: 3 months
Pain score according to the daily NRS scale (Numeric Pain Rating Scale), Numeric Pain Rating Scale, for 15 days POP and subsequently monthly until completing 3 months. is scores from 0 to 10, 10 being the worst value.
Phantom Limp Pain
Time frame: 3 months
For this qualitative dichotomous outcome, you will ask about symptomatology referring to phantom limb pain for 15 days POP and subsequently monthly until completing 3 months, It will be qualified as positive if it presents any neuropathic symptom.
6 secondary outcomes
Phantom Limp Pain first Year
Time frame: 1 year
Opioid Consumption
Time frame: 36 hours
Incidence of nausea and vomiting POP
Time frame: 36 hours
Incidence of adverse effects
Time frame: 1 year
Days of hospital stay
Time frame: during the time of hospitalization, on average 10 days
Mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 31248645Edgley C, Hogg M, De Silva A, Braat S, Bucknill A, Leslie K. Severe acute pain and persistent post-surgical pain in orthopaedic trauma patients: a cohort study. Br J Anaesth. 2019 Sep;123(3):350-359. doi: 10.1016/j.bja.2019.05.030. Epub 2019 Jun 24.
- Background: PubMed 29973967De Jong R, Shysh AJ. Development of a Multimodal Analgesia Protocol for Perioperative Acute Pain Management for Lower Limb Amputation. Pain Res Manag. 2018 Jun 3;2018:5237040. doi: 10.1155/2018/5237040. eCollection 2018.
- Background: PubMed 12579385Gehling M, Tryba M. [Prophylaxis of phantom pain: is regional analgesia ineffective?]. Schmerz. 2003 Jan;17(1):11-9. doi: 10.1007/s00482-002-0198-2. German.
- Individual participant dataSharing planned: No. public bases of data
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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.
Mario Zamudio, Prof study director
IPS universitaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epidural catheter and Continuous sciatic nerve block in people with Phantom Limb Pain and Pain, Chronic, run by Universidad de Antioquia at 1 site in Colombia.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Nov 2022. 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 Colombia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela González, Md (3122690961, daniela.gonzalezg@udea.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posoperative Pain (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT05608733, which also lists 3 linked publications.
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 8 Nov 2022.