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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative

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 Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

twenty-six consecutive ASA physical status I or II ambulatory patients (study group, SG) scheduled for elective hallux valgus surgery were enrolled. All patients had unilateral procedures

Description

Inclusion Criteria:

• hallux valgus deformity
• pain
• walking difficulty with shoes

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Study Group; In the study Group the investigators enrolled 26 patients scheduled for hallux valgus surgery and treated with a new analgesici approach. After sub-gluteal sciatic nerve block with short acting local anesthetic (mepivacaine 2%, 15 ml), each patient received an ultrasound-guided Posterior Tibial Nerve Block (PTNB) with levobupivacaine 0,5% (7-8 ml). The investigators measured: the intensity of pain at the baseline (before the surgery) and at 3, 6, 12 and 24 hours (h) using a Visual Analogue Scale (VAS); the consumption of oxycodone in the first 24 hours after surgical treatment and the motor recovery using modified Bromage score.
Control group; The investigators compared the study group with a control group of 26 patients previously scheduled for the same surgery and treated with another post-operative analgesia technique more frequently used in our hospital: local infiltration (Local Infiltration Anesthesia, LIA) with levobupivacaine 0, 5% (15 ml) performed by the surgeon directly on the operative site.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Giuliano Ferrone, Fondazione Policlinico Gemelli

Publications and helpful links

General Publications

• Singelyn FJ. Single-injection applications for foot and ankle surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):247-54. doi: 10.1053/bean.2002.0236.
• Turan I, Assareh H, Rolf C, Jakobsson J. Multi-modal-analgesia for pain management after Hallux Valgus surgery: a prospective randomised study on the effect of ankle block. J Orthop Surg Res. 2007 Dec 18;2:26. doi: 10.1186/1749-799X-2-26.
• Samuel R, Sloan A, Patel K, Aglan M, Zubairy A. The efficacy of combined popliteal and ankle blocks in forefoot surgery. J Bone Joint Surg Am. 2008 Jul;90(7):1443-6. doi: 10.2106/JBJS.G.01133.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): July 5, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: December 29, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 11, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Analgesia technique; Pain control
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Foot Deformities; Pain, Postoperative; Hallux Valgus
• Other Study ID Numbers: 50990/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No