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Could a lower dose of spinal anesthetic protect elderly patients during surgery?

NCT ID NCT07684989

Symptom relief Sponsor: Mayo Hospital Lahore Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This trial compares a low dose versus a standard dose of the spinal anesthetic bupivacaine in adults aged 65 and older undergoing lower leg surgery. The goal is to see if the lower dose reduces dangerous drops in blood pressure and heart rate while still providing effective anesthesia and faster recovery. Participants are randomly assigned to receive either the low or standard dose, and their vital signs and recovery times are closely monitored.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bupivacaine
What this could lead to
If successful, this could lead to a safer spinal anesthesia method for elderly patients, reducing complications like dangerous drops in blood pressure and speeding up recovery after surgery.
What could go wrong
This is a single-center Phase 4 trial with 180 participants, so results may not apply broadly. The lower dose might not provide enough pain control during surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female patients aged 65 years and above. * Patients scheduled for elective lower limb orthopedic surgery under spinal anesthesia. * American Society of Anesthesiologists (ASA) physical status I-III. * Patients willing to participate and provide written informed consent. Exclusion Criteria: * Refusal to participate in the study. * Contraindications to spinal anesthesia (e.g., infection at puncture site, coagulopathy, severe hypovolemia, raised intracranial pressure). * Known hypersensitivity or allergy to bupivacaine. * Severe valvular heart disease. * Significant cardiac arrhythmias. * Uncontrolled hypertension. * Severe hepatic or renal impairment. * Pre-existing neurological disorders affecting lower limb motor or sensory function. * Severe spinal deformity or previous lumbar spine surgery interfering with spinal anesthesia. * Cognitive impairment or inability to provide informed consent. * Emergency orthopedic procedures.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia, spinal Bupivacaine Hemodynamics Orthopedic procedures Postoperative recovery in elderly patients

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Mayo Hospital, Lahore

    Lahore, Punjab Province, 54950, Pakistan

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