Lower Limb SurgeryPhase 4NCT07896798
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
A Phase 4 study testing Bubpivacaine, Tramadol and Saline in people with Lower Limb Surgery and Pain, run by Aga Khan University.
Trial summary
The goal of this randomized controlled clinical trial is to evaluate the effectiveness of postoperative bupivacaine infusion through a perineural catheter in managing postoperative pain and to determine the opioid consumption among patients undergoing major lower-limb amputation surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lower Limb Surgery, Pain, Phantom Limb Pain After Amputation
- What is being tested?
- Bubpivacaine, Tramadol and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and above
- Patients undergoing lower limb amputation.
- ASA status I to IV.
- Patients under general or spinal anaesthesia
Who cannot join
- Patients with no allergies to study drugs (inje Bupivacaine 0.125%, Inje Tramadol, Inje Morphine)
- Pregnant and lactating patients
- Patients who require post-operative ventilatory support in ICU
- Those with open wound of amputation stump
- Procedures performed under peripheral nerve block
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohsin N Butt, MBBS, FCPS (Anesthesiology) contact
About this study
Official title: Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb: A Randomized Controlled Trial.
The goal of this randomized controlled clinical trial is to evaluate the effectiveness of postoperative bupivacaine infusion through a perineural catheter in managing postoperative pain and to determine the opioid consumption among patients undergoing major lower-limb amputation surgery.
The main questions it aims to answer are:
- Does postoperative bupivacaine infusion through a perineural catheter provide better postoperative pain control as compared to intravenous opioid analgesia alone?
- Does postoperative bupivacaine infusion through a perineural catheter reduce intravenous opioid consumption within the first 48 hours after surgery compared with intravenous opioid analgesia alone?
- Does the postoperative Bupivacaine infusion through perineural catheter help in reducing the phantom pain at 6 months follow-up?
- Being tested
- Bubpivacaine, Tramadol, Saline
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BubpivacaineDrug
Bupivacaine (0.125%) infusion will be stated Postoperatively
TramadolDrug
The opioid infusion will consist of the standard of care for pain control (Tramadol 10mg/ml ) after major amputation. Infusion rate and dosage will be determined as per the requirement for the individual patient and patient who will not respond to Tramadol infusion will receive Morphine 2mg IV stat as a rescue analgesia.
SalineDrug
Saline will be started through the peri-neural catheter postoperatively
| Study group | Role | What they receive |
|---|---|---|
| PBI Group | Experimental | Patients will be given bupivacaine infusion (0.125%) through perineural catheter postoperatively Receives: Drug: Bubpivacaine; Drug: Tramadol |
| POI Group | Placebo comparator | Placebo and opioid. The opioid infusion will consist of the standard of care for pain control (Tramadol 10mg/ml, morphine 2mg IV as rescue analgesia ) after major amputation. Infusion rate and dosage will be determined as per the requirement for the individual patient. Receives: Drug: Tramadol; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative pain will be measured at different timepoints through numerical rating scale (NRS). NRS is 10 points scale , where '0' represents 'no pain' and '10' represents the worst pain imaginable.
Measured: First pain assessment will be done after half hour of PACU stay. Subsequently pain will be assessed at six hours, 12 hours, 24 hours and 48 hours postoperatively.
Opioid consumption
opioid consumption ie Tramadol in mg/ 48hr and Morphine use in mg/48hr
Measured: Opioid consumption will be assessed 48 hours postoperatively
Secondary outcomes (1)
Incidence of phantom limb pain
Phantom limb pain: patient who develop this pain based on a set criteria for phantom pain ( ref: https://www.iasp-pain.org/current-understanding-of-phantom-pain-and-its-treatment/)
Measured: At 6 months Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Lower Limb SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fareed Shaikh, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896798
- Sponsor's protocol ID
- 2025-8029-38445
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
PubMed 16320034Merritt CK, Mariano ER, Kaye AD, Lissauer J, Mancuso K, Prabhakar A, Urman RD. Peripheral nerve catheters and local anesthetic infiltration in perioperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Mar;28(1):41-57. doi: 10.1016/j.bpa.2014.02.002. Epub 2014 Mar 18.
PubMed 24815966von Plato H, Peltoniemi M, Kauhanen P, Loyttyniemi E, Hamunen K, Kontinen V; FinAPain-1 study group. Combination of perineural and wound infusion after above knee amputation: A randomized, controlled multicenter study. Acta Anaesthesiol Scand. 2019 Nov;63(10):1406-1412. doi: 10.1111/aas.13440. Epub 2019 Jul 19.
PubMed 31281981Pinzur MS, Garla PG, Pluth T, Vrbos L. Continuous postoperative infusion of a regional anesthetic after an amputation of the lower extremity. A randomized clinical trial. J Bone Joint Surg Am. 1996 Oct;78(10):1501-5. doi: 10.2106/00004623-199610000-00007.
PubMed 8876577von Plato H, Kontinen V, Hamunen K. Efficacy and safety of epidural, continuous perineural infusion and adjuvant analgesics for acute postoperative pain after major limb amputation - a systematic review. Scand J Pain. 2018 Jan 26;18(1):3-17. doi: 10.1515/sjpain-2017-0170.
PubMed 29794290Ayling OG, Montbriand J, Jiang J, Ladak S, Love L, Eisenberg N, Katz J, Clarke H, Roche-Nagle G. Continuous regional anaesthesia provides effective pain management and reduces opioid requirement following major lower limb amputation. Eur J Vasc Endovasc Surg. 2014 Nov;48(5):559-64. doi: 10.1016/j.ejvs.2014.07.002. Epub 2014 Aug 16.
PubMed 25139251Bosanquet DC, Glasbey JC, Stimpson A, Williams IM, Twine CP. Systematic review and meta-analysis of the efficacy of perineural local anaesthetic catheters after major lower limb amputation. Eur J Vasc Endovasc Surg. 2015 Aug;50(2):241-9. doi: 10.1016/j.ejvs.2015.04.030. Epub 2015 Jun 9.
PubMed 26067167Lambert Aw, Dashfield Ak, Cosgrove C, Wilkins Dc, Walker Aj, Ashley S. Randomized prospective study comparing preoperative epidural and intraoperative perineural analgesia for the prevention of postoperative stump and phantom limb pain following major amputation. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):316-21. doi: 10.1053/rapm.2001.23934.
PubMed 11464349Nikolajsen L, Staehelin Jensen T. Phantom limb pain. Curr Rev Pain. 2000;4(2):166-70. doi: 10.1007/s11916-000-0052-0.
PubMed 10998730McQuay HJ, Moore RA, Kalso E. Phantom-limb pain. Lancet. 1998 Feb 21;351(9102):595. doi: 10.1016/s0140-6736(98)26008-9. No abstract available.
PubMed 9492802
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07896798
- Acronym / sponsor ID
- 2025-8029-38445
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 27 Oct 2026 (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.
The goal of this randomized controlled clinical trial is to evaluate the effectiveness of postoperative bupivacaine infusion through a perineural catheter in managing postoperative pain and to determine the opioid consumption among patients undergoing major lower-limb amputation surgery.
The main questions it aims to answer are:
- Does postoperative bupivacaine infusion through a perineural catheter provide better postoperative pain control as compared to intravenous opioid analgesia alone?
- Does postoperative bupivacaine infusion through a perineural catheter reduce intravenous opioid consumption within the first 48 hours after surgery compared with intravenous opioid analgesia alone?
- Does the postoperative Bupivacaine infusion through perineural catheter help in reducing the phantom pain at 6 months follow-up?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBI Group | Experimental | Drug: Bubpivacaine, Drug: TramadolPatients will be given bupivacaine infusion (0.125%) through perineural catheter postoperatively |
| POI Group | Placebo comparator | Drug: Tramadol, Drug: SalinePlacebo and opioid. The opioid infusion will consist of the standard of care for pain control (Tramadol 10mg/ml, morphine 2mg IV as rescue analgesia ) after major amputation. Infusion rate and dosage will be determined as per the requirement for the individual patient. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 and above
- Patients undergoing lower limb amputation.
- ASA status I to IV.
- Patients under general or spinal anaesthesia
Key exclusion criteria (5 listed)
- Patients with no allergies to study drugs (inje Bupivacaine 0.125%, Inje Tramadol, Inje Morphine)
- Pregnant and lactating patients
- Patients who require post-operative ventilatory support in ICU
- Those with open wound of amputation stump
- Procedures performed under peripheral nerve block
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 |
|---|---|---|
| BubpivacaineBupivacaine (0.125%) infusion will be stated Postoperatively | Drug | PBI Group |
| TramadolThe opioid infusion will consist of the standard of care for pain control (Tramadol 10mg/ml ) after major amputation. Infusion rate and dosage will be determined as per the requirement for the individual patient and patient who will not respond to Tramadol infusion will receive Morphine 2mg IV stat as a rescue analgesia. | Drug | PBI Group, POI Group |
| SalineSaline will be started through the peri-neural catheter postoperatively | Drug | POI Group |
Primary outcome
Postoperative Pain
Time frame: First pain assessment will be done after half hour of PACU stay. Subsequently pain will be assessed at six hours, 12 hours, 24 hours and 48 hours postoperatively.
Postoperative pain will be measured at different timepoints through numerical rating scale (NRS). NRS is 10 points scale , where '0' represents 'no pain' and '10' represents the worst pain imaginable.
Opioid consumption
Time frame: Opioid consumption will be assessed 48 hours postoperatively
opioid consumption ie Tramadol in mg/ 48hr and Morphine use in mg/48hr
1 secondary outcome
Incidence of phantom limb pain
Time frame: At 6 months Postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 16320034Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
- Background: PubMed 24815966Merritt CK, Mariano ER, Kaye AD, Lissauer J, Mancuso K, Prabhakar A, Urman RD. Peripheral nerve catheters and local anesthetic infiltration in perioperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Mar;28(1):41-57. doi: 10.1016/j.bpa.2014.02.002. Epub 2014 Mar 18.
- Background: PubMed 31281981von Plato H, Peltoniemi M, Kauhanen P, Loyttyniemi E, Hamunen K, Kontinen V; FinAPain-1 study group. Combination of perineural and wound infusion after above knee amputation: A randomized, controlled multicenter study. Acta Anaesthesiol Scand. 2019 Nov;63(10):1406-1412. doi: 10.1111/aas.13440. Epub 2019 Jul 19.
- Background: PubMed 8876577Pinzur MS, Garla PG, Pluth T, Vrbos L. Continuous postoperative infusion of a regional anesthetic after an amputation of the lower extremity. A randomized clinical trial. J Bone Joint Surg Am. 1996 Oct;78(10):1501-5. doi: 10.2106/00004623-199610000-00007.
- Background: PubMed 29794290von Plato H, Kontinen V, Hamunen K. Efficacy and safety of epidural, continuous perineural infusion and adjuvant analgesics for acute postoperative pain after major limb amputation - a systematic review. Scand J Pain. 2018 Jan 26;18(1):3-17. doi: 10.1515/sjpain-2017-0170.
- Background: PubMed 25139251Ayling OG, Montbriand J, Jiang J, Ladak S, Love L, Eisenberg N, Katz J, Clarke H, Roche-Nagle G. Continuous regional anaesthesia provides effective pain management and reduces opioid requirement following major lower limb amputation. Eur J Vasc Endovasc Surg. 2014 Nov;48(5):559-64. doi: 10.1016/j.ejvs.2014.07.002. Epub 2014 Aug 16.
- Background: PubMed 26067167Bosanquet DC, Glasbey JC, Stimpson A, Williams IM, Twine CP. Systematic review and meta-analysis of the efficacy of perineural local anaesthetic catheters after major lower limb amputation. Eur J Vasc Endovasc Surg. 2015 Aug;50(2):241-9. doi: 10.1016/j.ejvs.2015.04.030. Epub 2015 Jun 9.
- Background: PubMed 11464349Lambert Aw, Dashfield Ak, Cosgrove C, Wilkins Dc, Walker Aj, Ashley S. Randomized prospective study comparing preoperative epidural and intraoperative perineural analgesia for the prevention of postoperative stump and phantom limb pain following major amputation. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):316-21. doi: 10.1053/rapm.2001.23934.
- Background: PubMed 10998730Nikolajsen L, Staehelin Jensen T. Phantom limb pain. Curr Rev Pain. 2000;4(2):166-70. doi: 10.1007/s11916-000-0052-0.
- Background: PubMed 9492802McQuay HJ, Moore RA, Kalso E. Phantom-limb pain. Lancet. 1998 Feb 21;351(9102):595. doi: 10.1016/s0140-6736(98)26008-9. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Mohsin N Butt, MBBS, FCPS (Anesthesiology) contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bubpivacaine, Tramadol and Saline in people with Lower Limb Surgery and Pain, run by Aga Khan University.
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 5 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fareed Shaikh, MBBS, MRCSEd, FCPS(Vascular) (+923218110155 ext. 4708, fareed.shaikh@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: First pain assessment will be done after half hour of PACU stay. Subsequently pain will be assessed at six hours, 12 hours, 24 hours and 48 hours postoperatively.). 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 NCT07896798, which also lists 10 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 2 Nov 2026.