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Not yet recruitingNCT07896798Updated Nov 2, 2026

Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb

A Phase 4 interventional study of Bubpivacaine and Tramadol in Lower Limb Surgery, Pain and Phantom Limb Pain After Amputation, sponsored by Aga Khan University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Aga Khan University · Phase 4, Interventional, and Treatment

Updated Nov 2, 2026Primary outcomes revisedInterventions changed+1 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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?
02

Conditions studied

  • Lower Limb Surgery
  • Pain
  • Phantom Limb Pain After Amputation
  • Stump Pain
  • Amputation

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03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 96 is above the median of 66 across 8,493 interventional studies indexed under Pain.

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Lead sponsor

Aga Khan University is the lead sponsor of 294 studies on the registry; 43 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 and above
  • Patients undergoing lower limb amputation.
  • ASA status I to IV.
  • Patients under general or spinal anaesthesia

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    PBI Group

    Patients will be given bupivacaine infusion (0.125%) through perineural catheter postoperatively

    Drug: Bubpivacaine · Drug: Tramadol

  • Placebo comparator
    POI Group

    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.

    Drug: Tramadol · Drug: Saline

Interventions

  • DrugBubpivacaine

    Bupivacaine (0.125%) infusion will be stated Postoperatively

  • DrugTramadol

    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.

  • DrugSaline

    Saline will be started through the peri-neural catheter postoperatively

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. Opioid consumption

    opioid consumption ie Tramadol in mg/ 48hr and Morphine use in mg/48hr

    Time frame: 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/)

    Time frame: At 6 months Postoperatively

07

Study locations

No study locations are listed for this record.

08

References and documents

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 16320034 ↗
  • Merritt 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 24815966 ↗
  • von 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 31281981 ↗
  • Pinzur 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 8876577 ↗
  • von 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 29794290 ↗
  • Ayling 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 25139251 ↗
  • Bosanquet 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 26067167 ↗
  • Lambert 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 11464349 ↗
  • Nikolajsen L, Staehelin Jensen T. Phantom limb pain. Curr Rev Pain. 2000;4(2):166-70. doi: 10.1007/s11916-000-0052-0. PubMed 10998730 ↗
  • McQuay 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Nov 2027, 11 months later.

Of 280 non-industry phase 4 interventional studies under Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 11 months is below that.

Counting every sponsor, half of 295 studies reached it within 18 months; a quarter within 8 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2026
First posted
Oct 27, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Nov 30, 2027
CompletionEst.
Jul 2028
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Interventions
Changed Bupivacaine Infusion→Bubpivacaine. Added Drug: Tramadol; removed Drug: Opioid Infusion
Nov 2, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionOpioid consumption: how it is measured was reworded
Nov 2, 2026
Secondary outcomes
1 description edited
What changed in the outcomes
  • DescriptionIncidence of phantom limb pain: how it is measured was reworded
Nov 2, 2026
Registered
First appeared on the registry
Oct 27, 2026
Show all 2 updates
  1. Nov 2, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionOpioid consumption: how it is measured was reworded
    Secondary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionIncidence of phantom limb pain: how it is measured was reworded
    Interventions Changed Bupivacaine Infusion→Bubpivacaine. Added Drug: Tramadol; removed Drug: Opioid Infusion
    + 1 other change: index terms
  2. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07896798
Lead sponsor
Aga Khan University
Responsible party
Fareed Shaikh (Assistant Professor, Aga Khan University) — Principal investigator
First posted
Oct 27, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Nov 30, 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Fareed Shaikh, MBBS, MRCSEd, FCPS(Vascular)
Contact
fareed.shaikh@aku.edu
+923218110155 ext. 4708
Mohsin N Butt, MBBS, FCPS (Anesthesiology)
Contact
+923212227083

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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