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Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ankle Block
Sciatic nerve block
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are going to undergo a unilateral forefoot surgery ;
  • ASA I-III ;
  • Aged 18 years or more;
  • Weighing at least 45 kg

Exclusion Criteria:

  • Patient refusal and/or language/cognitive barrier
  • Pregnancy
  • Contra-indication for regional anesthesia
  • Opiate or alcohol dependency
  • Concomitant oncological disease with chemotherapy
  • Patients suffering from neuropathic pain

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois and University of Lausanne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ankle Block

Popliteal sciatic nerve block (PSNB)

Arm Description

Ankle block will be performed under ultrasound guidance.

PSNB will be performed under ultrasound guidance, along with a saphenous nerve block at the ankle

Outcomes

Primary Outcome Measures

Duration of analgesia
Time elapsed between block procedure and first iv request of morphine from PCA

Secondary Outcome Measures

Total opioid consumption at 24h postoperatively
Total consumption of morphine from PCA at 24 postoperative hours
Pain score at rest at 4 postoperative hours
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Pain score on movement at 4 postoperative hours
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Pain score at rest at 12 postoperative hours
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Pain score on movement at 12 postoperative hours
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Pain score at rest at 24 postoperative hours
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Pain score on movement at 24 postoperative hours
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Block success rate
Success of block assessed by pinprick test
Global patient satisfaction 48h after surgery
Patient satisfaction score (visual analog scale, 0 = minimum; 10 = maximum)
Complications after block
Report of any intravascular injection or any sensory/motor anomalies
Rate of neuropathic pain
Rate of patients describing neuropathic pain 4-6 weeks postoperatively
Rate of paresthesia
Rate of patients complaining of paresthesia
Block procedure time
Time from first ultrasound image to needle withdrawal

Full Information

First Posted
September 20, 2018
Last Updated
August 2, 2023
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT03683342
Brief Title
Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery
Official Title
Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pain after forefoot surgery can be important and regional anesthesia plays a crucial role in post-operative pain control. Several techniques can be used to achieve surgical anesthesia as well as postoperative analgesia. Of those techniques the ankle block and sciatic nerve block at the popliteal fossa are the most common. The primary goal of this study is thus to compare the analgesic duration of these two types of blocks for patients undergoing forefoot surgery.
Detailed Description
Patients scheduled for unilateral forefoot surgery, aged over 18 years old and ASA status I-III without any contra-indications for regional anesthesia will be enrolled. After a standard randomisation, patients will be allocated in either of two groups : ankle block or sciatic nerve block at the popliteal fossa. In both groups the patients will have a multimodal analgesic regimen followed by a patient-controlled-analgesia (PCA) of morphine. The primary endpoint is the analgesic duration, defined by the time between the end of the block procedure and the first IV request of morphine from a PCA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ankle Block
Arm Type
Active Comparator
Arm Description
Ankle block will be performed under ultrasound guidance.
Arm Title
Popliteal sciatic nerve block (PSNB)
Arm Type
Active Comparator
Arm Description
PSNB will be performed under ultrasound guidance, along with a saphenous nerve block at the ankle
Intervention Type
Procedure
Intervention Name(s)
Ankle Block
Intervention Description
Ankle block will be performed prior to surgery under ultrasound guidance
Intervention Type
Procedure
Intervention Name(s)
Sciatic nerve block
Intervention Description
Sciatic nerve block will be performed prior to surgery under ultrasound guidance
Primary Outcome Measure Information:
Title
Duration of analgesia
Description
Time elapsed between block procedure and first iv request of morphine from PCA
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Total opioid consumption at 24h postoperatively
Description
Total consumption of morphine from PCA at 24 postoperative hours
Time Frame
24 hours after surgery
Title
Pain score at rest at 4 postoperative hours
Description
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Time Frame
4 hours after surgery
Title
Pain score on movement at 4 postoperative hours
Description
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Time Frame
4 hours after surgery
Title
Pain score at rest at 12 postoperative hours
Description
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Time Frame
12 hours after surgery
Title
Pain score on movement at 12 postoperative hours
Description
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Time Frame
12 hours after surgery
Title
Pain score at rest at 24 postoperative hours
Description
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Time Frame
24 hours after surgery
Title
Pain score on movement at 24 postoperative hours
Description
Pain score (visual analog scale, 0 = minimum; 10 = maximum)
Time Frame
24 hours after surgery
Title
Block success rate
Description
Success of block assessed by pinprick test
Time Frame
45 minutes after block procedure
Title
Global patient satisfaction 48h after surgery
Description
Patient satisfaction score (visual analog scale, 0 = minimum; 10 = maximum)
Time Frame
48 hours after surgery
Title
Complications after block
Description
Report of any intravascular injection or any sensory/motor anomalies
Time Frame
48 hours after surgery
Title
Rate of neuropathic pain
Description
Rate of patients describing neuropathic pain 4-6 weeks postoperatively
Time Frame
4-6 weeks postoperatively
Title
Rate of paresthesia
Description
Rate of patients complaining of paresthesia
Time Frame
Up to 24 hours after block procedure
Title
Block procedure time
Description
Time from first ultrasound image to needle withdrawal
Time Frame
Up to 10 minutes after ultrasound scanning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are going to undergo a unilateral forefoot surgery ; ASA I-III ; Aged 18 years or more; Weighing at least 45 kg Exclusion Criteria: Patient refusal and/or language/cognitive barrier Pregnancy Contra-indication for regional anesthesia Opiate or alcohol dependency Concomitant oncological disease with chemotherapy Patients suffering from neuropathic pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Albrecht, PD Dr
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois and University of Lausanne
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery

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