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

Completed

• Conditions: Pain, Postoperative

• Registration Number: NCT03396991
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2017-07-05
• Study Completion: 2017-10-01
• Study First Submitted: 2017-12-29
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• hallux valgus deformity
• pain
• walking difficulty with shoes

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain control measured by a visual analogue scale of Scott-Huskisson (VAS score)	One month	Pain control measured by a visual analogue scale of Scott-Huskisson (VAS, 0 lack of pain, 10 the worst pain).

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli; 🇮🇹 Rome, Italy