Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07550348

Bupivacaine-Lidocaine Combination Versus Bupivacaine Alone for Ultrasound-Guided Popliteal Sciatic Nerve Block in Elective Lower Extremity Surgery: A Prospective Randomized Double-Blind Trial

Led by Ataturk University · Updated on 2026-05-12

60

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two local anesthetic methods for ultrasound-guided popliteal sciatic nerve block in adults aged 18 to 65 undergoing elective distal lower leg surgery. This study focuses on how quickly sensory and motor blockades begin and evaluates several postoperative outcomes such as pain levels, opioid use, and recovery quality. The trial is conducted at Ataturk University Research Hospital in Turkey with 60 participants divided into two groups. Participants will receive one of two treatments before surgery: one group gets a combination of lidocaine and bupivacaine, while the other group receives bupivacaine alone. Both treatments involve 20 mL total volume administered via ultrasound guidance to the popliteal sciatic nerve. Some patients may also receive an additional adductor canal block. During surgery, sedation and vital signs are carefully monitored, and standardized postoperative pain relief is provided. Throughout the study, researchers will assess block onset time, success rates, duration of sensory and motor block, and pain scores at multiple time points up to 24 hours after surgery. They will also monitor opioid use, quality of recovery, and any rebound pain. Neurological assessments are performed one week after surgery to check for any nerve issues. The study uses a double-blind design, with patients and outcome assessors unaware of the treatment group.

CONDITIONS

Brief Title

Bupivacaine-Lidocaine vs Bupivacaine for Ultrasound-Guided Popliteal Sciatic Nerve Block

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • ASA physical status classification I, II, or III
  • Scheduled for elective distal lower extremity surgery below the knee
  • Body mass index (BMI) between 18 and 35 kg/m8
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study
  • Morbid obesity (BMI 6 or greater)
  • Known allergy or hypersensitivity to any local anesthetic agent
  • Severe cardiac, hepatic, or renal disease
  • Pre-existing neurological deficits or peripheral neuropathy
  • Use of anticoagulant therapy
  • History of prior surgery or significant scar tissue in the popliteal fossa
  • Pregnancy
  • Chronic opioid use at home

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day

Participants receive an ultrasound-guided popliteal sciatic nerve block with either a bupivacaine-lidocaine combination or bupivacaine alone before elective lower extremity surgery.

1 visit (in-person) for block administration and surgery

Post-operative Follow-up

Duration - Up to 7 days postoperatively

Participants are monitored for pain levels, opioid consumption, block duration, and neurological status following the nerve block and surgery.

Multiple visits including assessments at 2, 4, 8, 12, and 24 hours postoperatively and a neurological assessment at postoperative day 7

Trial Site Locations

Total: 1 location

1

Ataturk University

Erzurum, Turkey (Türkiye)

Actively Recruiting

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Research Team

A

AHMET MURAT YAYIK, MD, PhD

A

ASLIHAN BOROGLU, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial