Unilateral Spinal Anesthesia vs Popliteal-Adductor Canal Block for Below-knee Amputation

NCT07854158 | Not Yet Recruiting

• 1 other identifier: SMC-ANS-2025-0014
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Postoperative analgesia

  This will be assessed by visual analogue scale

  24 hours

• Total analgesic consumption

  24 hours

Secondary Outcomes (2)

• Complication

  With in 24 hours

• Hemodynamics variable

  With in 24 hours

Study Arms (2)

Unilateral spinal anesthesia

OTHER

Drug: 0.5 % hyperbaric Bupvicaine

Combination popliteal and adductor canal nerve block

OTHER

Drug: 15 ml of 0.5 bupvicaine

Interventions

0.5 % hyperbaric Bupvicaine DRUG

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

Unilateral spinal anesthesia

15 ml of 0.5 bupvicaine DRUG

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

Combination popliteal and adductor canal nerve block

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sargodha Medical College: lead

Study Sites (1)

Dr Faisal Masood teaching Hospital Sargodha

Sargodha, Punjab Province, 40100, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Saba Akram, MBBS, FCPS Anesthesia

CONTACT

+92 309 2592868; Usama7140@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 2, 2026
• Study Start: September 5, 2026
• Primary Completion (Estimated): August 14, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)