Postoperative PainNCT07854158
Unilateral Spinal Anesthesia vs Popliteal-Adductor Canal Block for Below-knee Amputation
A study testing 0.5 % hyperbaric Bupvicaine and 15 ml of 0.5 bupvicaine in people with Postoperative Pain, run by Sargodha Medical College at 1 site in Pakistan.
Trial summary
To compare the mean duration of postoperative analgesia between unilateral spinal anaesthesia and combined popliteal sciatic nerve block with adductor canal block in diabetic patients undergoing below-knee amputation. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- 0.5 % hyperbaric Bupvicaine and 15 ml of 0.5 bupvicaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Sep 2026to 30 Aug 2027
- Phase
- Interventional
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 40 to 75 years, of either gender.
- Known type 2 diabetes mellitus scheduled for below-knee amputation.
- ASA physical status II or III.
Who cannot join
- Documented allergy to amide local anaesthetics.
- A bleeding tendency, or the use of anticoagulant or antiplatelet drugs, makes regional anaesthesia unsafe.
- Skin infection at the spinal or block puncture site.
- Pre-existing nerve disease of the same limb that would confuse block assessment.
- Severe uncontrolled cardiac disease, sepsis, or unstable circulation at presentation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Dr Faisal Masood teaching Hospital Sargodha
Sargodha, Punjab Province, 40100
About this study
Official title: Comparison of Unilateral Spinal Anaesthesia Versus Combined Popliteal and Adductor Canal Block for Below-knee Amputation in Diabetic Patients
To compare the mean duration of postoperative analgesia between unilateral spinal anaesthesia and combined popliteal sciatic nerve block with adductor canal block in diabetic patients undergoing below-knee amputation.
- Conditions
- Postoperative Pain
- Being tested
- 0.5 % hyperbaric Bupvicaine, 15 ml of 0.5 bupvicaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 % hyperbaric BupvicaineDrug
Patients in Group A will receive unilateral spinal anaesthesia. The anesthesiologist will inject a small dose of 0.5% hyperbaric bupivacaine through a pencil-point spinal needle, keep the limb to be operated on in the dependent position, and hold the lateral posture for about fifteen minutes so the block settles on one side. Patients in Group B will receive an ultrasound-guided popliteal sciatic nerve block together wi
15 ml of 0.5 bupvicaineDrug
Group B will receive 15 mL of 0.5% bupivacaine for the popliteal sciatic nerve block and 10 mL of 0.25% bupivacaine for the adductor canal block (total 25 mL), keeping the total dose within 2 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Unilateral spinal anesthesia | Other | Not described Receives: Drug: 0.5 % hyperbaric Bupvicaine |
| Combination popliteal and adductor canal nerve block | Other | Not described Receives: Drug: 15 ml of 0.5 bupvicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
This will be assessed by visual analogue scale
Measured: 24 hours
Total analgesic consumption
Measured: 24 hours
Secondary outcomes (2)
Complication
Complication such as vascular puncture and Local anesthetic systemic toxicity
Measured: With in 24 hours
Hemodynamics variable
Variable such as Heart rate, Blood pressure
Measured: With in 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start5 Sep 2026 (estimated)
- Primary completion14 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sargodha Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854158
- Sponsor's protocol ID
- SMC-ANS-2025-0014
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Unilateral Spinal Anaesthesia Versus Combined Popliteal and Adductor Canal Block for Below-knee Amputation in Diabetic Patients
- ClinicalTrials.gov ID
- NCT07854158
- Acronym / sponsor ID
- SMC-ANS-2025-0014
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Sargodha Medical CollegeUniversity, hospital or other
- Study start
- 5 Sep 2026 (estimated)
- Primary completion
- 14 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 2 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.
To compare the mean duration of postoperative analgesia between unilateral spinal anaesthesia and combined popliteal sciatic nerve block with adductor canal block in diabetic patients undergoing below-knee amputation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral spinal anesthesia | Other | Drug: 0.5 % hyperbaric Bupvicaine |
| Combination popliteal and adductor canal nerve block | Other | Drug: 15 ml of 0.5 bupvicaine |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 40 to 75 years, of either gender.
- Known type 2 diabetes mellitus scheduled for below-knee amputation.
- ASA physical status II or III.
Key exclusion criteria (5 listed)
- Documented allergy to amide local anaesthetics.
- A bleeding tendency, or the use of anticoagulant or antiplatelet drugs, makes regional anaesthesia unsafe.
- Skin infection at the spinal or block puncture site.
- Pre-existing nerve disease of the same limb that would confuse block assessment.
- Severe uncontrolled cardiac disease, sepsis, or unstable circulation at presentation.
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 |
|---|---|---|
| 0.5 % hyperbaric BupvicainePatients in Group A will receive unilateral spinal anaesthesia. The anesthesiologist will inject a small dose of 0.5% hyperbaric bupivacaine through a pencil-point spinal needle, keep the limb to be operated on in the dependent position, and hold the lateral posture for about fifteen minutes so the block settles on one side. Patients in Group B will receive an ultrasound-guided popliteal sciatic nerve block together wi | Drug | Unilateral spinal anesthesia |
| 15 ml of 0.5 bupvicaineGroup B will receive 15 mL of 0.5% bupivacaine for the popliteal sciatic nerve block and 10 mL of 0.25% bupivacaine for the adductor canal block (total 25 mL), keeping the total dose within 2 mg/kg | Drug | Combination popliteal and adductor canal nerve block |
Primary outcome
Postoperative analgesia
Time frame: 24 hours
This will be assessed by visual analogue scale
Total analgesic consumption
Time frame: 24 hours
2 secondary outcomes
Complication
Time frame: With in 24 hours
Hemodynamics variable
Time frame: With in 24 hours
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 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.5 % hyperbaric Bupvicaine and 15 ml of 0.5 bupvicaine in people with Postoperative Pain, run by Sargodha Medical College at 1 site in Pakistan.
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 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 Oct 2026. 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 Pakistan. 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?
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 Saba Akram, MBBS, FCPS Anesthesia (+92 309 2592868, Usama7140@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia (time frame: 24 hours). 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?
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 Oct 2026.