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NCT Number: NCT03396991

Comparative Evaluation of Two Different Post-Operative Analgesia After Hallux Valgus Correction

Background: Recent studies showed the efficiency of several techniques of anesthesia in foot surgery. The new mini-invasive surgical approaches should require less analgesia and rapid motor recovery after surgery. The aim of this study was the evaluation of two different techniques on postoperative analgesia and motor recovery after hallux valgus correction in one-day surgery patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Gemelli

Rome, 00168, Italy

About this study

The hallux valgus surgery is often characterized by a significant post-operative pain difficult to control with oral analgesics. Consequently, large doses of parenteral opioids are often required Various nerve blocks (popliteal, saphenous, sciatic) can give excellent post-operative pain control. Among loco-regional anesthesia techniques, the sciatic nerve block provides good post-operative pain relief after foot surgery. Thus, sciatic nerve block with long-acting local anesthetics (with or without a peri-neural catheter) has been recommended as a primary option. This analgesic approach should cause a difficult discharge in ambulatory and one-day surgery patients, due to the prolonged motor recovery and loss of proprioception and protective pain reflexes. Therefore, it would be preferable to use the sciatic nerve block just for intra- operative anesthesia without affecting motor recovery, and to apply multimodal analgesia for post- operative pain management. Hallux valgus repair can now be done percutaneously, a minimally invasive technique called ''mini-invasive hallux valgus repair'', consisting in osteotomies through 3 to 5 mm incisions, without internal fixation. This approach requires less dissection and exposure, determining a smaller inflammatory response and theoretically causing less pain. Ideal anesthesia for these procedures should provide rapid patient recovery, minimal nursing care requirements in the post- anesthesia care unit and an earlier hospital discharge. It must provide effective analgesia, since the foot surgery is known to induce a moderate-to- severe post-operative pain, that represents one of the major limitations to hospital discharge on the day of surgery and is the main cause of re-admission.

The aim of this matched-control study was to evaluate two different techniques of post-operative analgesia after hallux valgus correction in one-day surgery patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hallux valgus deformity
  • pain
  • walking difficulty with shoes

Exclusion criteria

  • peripheral circulatory disorders
  • foot skin lesion
  • local anesthetic allergy

Treatment and study plan

Primary outcomes

  1. Pain control measured by a visual analogue scale of Scott-Huskisson (VAS score)

    Time frame: One month

    Pain control measured by a visual analogue scale of Scott-Huskisson (VAS, 0 lack of pain, 10 the worst pain).

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Comparative Evaluation of Two Different Post-Operative Analgesia After Hallux Valgus Correction in One-day Surgery Patients

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2018
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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