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Erector Spinae Plane Block and Ankle and Foot Surgery

Primary Purpose

Pain, Ankle Injuries

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound
Bupivacaine Hydrochloride
saline solution
Needle
Sponsored by
Fayoum University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring Erector spinae block, Ankle and foot surgery, Postoperative analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 18 - 65 years, American Society of Anesthesiologists physical status classification Ι and ΙΙ; scheduled for ankle and foot surgery Exclusion Criteria: Major hepatic severe renal impairment (creatinine > 3 or on dialysis); severe cardiovascular disease (ejection fraction < 35%) local infection at site of injection Any contraindication for ESP Known allergy to any drug used in the study

Sites / Locations

  • Fayoum University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control group

ESP group

Arm Description

The control group underwent US-guided sham block at L4 vertebrae level with 20 ml of saline 0.9%. At the level of L4 and after skin sterilization, sham block was administered in a sitting position. Hydro dissection of the interfascial plane between the erector spinae muscle and TP was confirmed by visualizing the local anesthetic spreading in a linear pattern between the muscle and the bony acoustic shadows of the TP. Then, up to 20 ml Saline 0.9% was injected.

The ESP group underwent US-guided ESP block at L4 vertebrae level with 20 ml of bupivacaine 0.25%. After skin sterilization, ESP block was administered in a sitting position. A linear US transducer was placed vertically 3 cm lateral to the midline to visualize back muscles: the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, as well as the TPs with shimmering pleura in between. Next, 2-3 ml of 2% lidocaine was infiltrated. Hydro dissection of the interfascial plane between the erector spinae muscle and TP was confirmed by visualizing the local anesthetic spreading in a linear pattern between the muscle and the bony acoustic shadows of the TP.

Outcomes

Primary Outcome Measures

Visual Analog score
0 - 10 with 0: no pain and 10: worst pain

Secondary Outcome Measures

Total opioid consumption
in milligram
time to first analgesic request
from end of operation to request of analgesia due to pain
Incidence of nausea
yes or no
Incidence of vomiting
yes or no
patient satisfaction
1:3 with 1: very satisfied to 3: very unsatified
Incidence of local anesthetic toxicity
yes or no
Visual Analog score
0 - 10 with 0: no pain and 10: worst pain
Visual Analog score
0 - 10 with 0: no pain and 10: worst pain
Visual Analog score
0 - 10 with 0: no pain and 10: worst pain

Full Information

First Posted
January 24, 2023
Last Updated
October 2, 2023
Sponsor
Fayoum University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05708742
Brief Title
Erector Spinae Plane Block and Ankle and Foot Surgery
Official Title
The Analgesic Efficacy of Erector Spinae Plane Block in Ankle and Foot Surgery: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Regional anesthesia is commonly used in orthopedic and surgical procedures in ankle and foot surgery to manage pain. The ultrasound-guided nerve block is a safe and effective regional anesthesia technique that provides effective pain management, decreasing opioid consumption. Postoperative pain management may be challenging and requires a multimodal approach. Regional anesthesia techniques in the pediatric ankle and foot surgery population are frequently used in postoperative pain management due to ultrasonography's increased experience and accessibility. Erector spinae plane block (ESP) is a relatively new regional anesthesia technique that provides analgesia covering spinal nerves' dorsal and ventral rami. There are few cases reports in the literature on the use of ESP block for lower limb surgery, for which it has a promising potential for future indication. The erector spinae plane block is a safe and effective regional anesthesia technique, which has earned new indications perioperatively since its description.
Detailed Description
This single-center study was a prospective randomized controlled trial, using parallel groups with a 1:1 allocation ratio. Eligible patients were identified by the surgeon and invited to participate in the study. If the patient wished to participate in the study, informed consent was obtained. The patient was informed of the study's nature, especially that the patient would be randomized to receive an ESPB or a sham block before the procedure. A computerized randomization program (permuted block randomization) was used to create the allocation before the beginning of the study. Research staff not involved in the recruitment process or the study's conduct randomized patients at the time of admission to the clinic. Randomization allocation was 1:1 between treatment and control groups. Apart from the anesthesiologists who performed the blocks, all patients, surgeons, and postoperative nurses remained blinded to randomization throughout the study period. The outcome parameters were recorded through a study nurse who was not involved in the patients' care. All patients received standardized anesthesia, and all blocks were performed by 2 anesthesiologists who were trained in this technique. A large-bore intravenous (IV) line was placed, and patients received midazolam 1 to 2 mg IV for anxiolysis. Anesthesia was induced with fentanyl 2 mcg.kg-1 and propofol 2 mg.kg-1 followed by atracurium 0.5 mg.kg-1 . After intubation, anesthesia was maintained with isoflurane (1 MAC) and atracurium 0.1mg.kg-1 as a maintenance dose every 30 min until the end of the procedure. After emerging from anesthesia, patients were transferred to the postanesthesia care unit (PACU) for a 2-h observation period. Patients were discharged from the PACU when they achieved a modified Aldrete score ≥ 9.10. Postoperative analgesia was provided in both groups immediately after surgery by PCA fentanyl pump, then oral acetaminophen 1 g four times a day. The criteria to stop the fentanyl titration protocol included satisfactory pain control, increased sedation (Ramsay sedation scale >2), decreased respiratory rate. Statistical Analyses The sample size was estimated to achieve a power of 0.8 to detect a supposed medium effect size of 0.7 in between the two groups regarding total morphine consumption, with a 2-sided significance level of .05 and allocation ratio of 1. Thirty patients in each group were required. Allowing for a 10% loss, 34 patients were recruited in each group, for a total of 68 patients. The sample size was determined using G*Power software (version 3.1.9.7). Descriptive statistics, including age, sex, body mass index, baseline pain scores, procedure type, traction time, and procedure time, were comparatively analyzed between the groups. Categorical data were compared with chi-squared and Fisher's exact tests as appropriate. Continuous data were compared with a 2-sided t test (for normally distributed data) and Wilcoxon rank-sum test (for non normally distributed data). For all analyses (primary and secondary measures), a P value of .05 was used to determine statistical significance. Statistical analyses were conducted using SPSS version 28 (Addinsoft, Paris, France).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Ankle Injuries
Keywords
Erector spinae block, Ankle and foot surgery, Postoperative analgesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Apart from the anesthesiologists who performed the blocks, all patients, surgeons, and postoperative nurses remained blinded to randomization throughout the study period.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
The control group underwent US-guided sham block at L4 vertebrae level with 20 ml of saline 0.9%. At the level of L4 and after skin sterilization, sham block was administered in a sitting position. Hydro dissection of the interfascial plane between the erector spinae muscle and TP was confirmed by visualizing the local anesthetic spreading in a linear pattern between the muscle and the bony acoustic shadows of the TP. Then, up to 20 ml Saline 0.9% was injected.
Arm Title
ESP group
Arm Type
Experimental
Arm Description
The ESP group underwent US-guided ESP block at L4 vertebrae level with 20 ml of bupivacaine 0.25%. After skin sterilization, ESP block was administered in a sitting position. A linear US transducer was placed vertically 3 cm lateral to the midline to visualize back muscles: the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, as well as the TPs with shimmering pleura in between. Next, 2-3 ml of 2% lidocaine was infiltrated. Hydro dissection of the interfascial plane between the erector spinae muscle and TP was confirmed by visualizing the local anesthetic spreading in a linear pattern between the muscle and the bony acoustic shadows of the TP.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Other Intervention Name(s)
Linear transducer
Intervention Description
A linear US transducer (Phillips-Saronno Italy) was placed vertically 3 cm lateral to the midline to visualize back muscles: the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, as well as the TPs with shimmering pleura in between.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
Local anesthetic
Intervention Description
The ESP block group underwent US-guided ESP block at L4 vertebrae level with 20 ml of bupivacaine 0.25%.
Intervention Type
Drug
Intervention Name(s)
saline solution
Other Intervention Name(s)
Saline isotonic 0.9%
Intervention Description
The control group underwent the same procedure but had a sham injection (20 ml of saline).
Intervention Type
Device
Intervention Name(s)
Needle
Intervention Description
A 22-gauge short bevel needle (Spinocan, B. Braun Melsungen AG, Germany) was inserted in the cranial-caudal direction towards the TP in-plane with the US transducer until the needle touched the TP crossing all three muscles.
Primary Outcome Measure Information:
Title
Visual Analog score
Description
0 - 10 with 0: no pain and 10: worst pain
Time Frame
8 hours after operation
Secondary Outcome Measure Information:
Title
Total opioid consumption
Description
in milligram
Time Frame
First 24 hours postoperatively.
Title
time to first analgesic request
Description
from end of operation to request of analgesia due to pain
Time Frame
First 24 hours postoperatively.
Title
Incidence of nausea
Description
yes or no
Time Frame
First 24 hours postoperatively.
Title
Incidence of vomiting
Description
yes or no
Time Frame
First 24 hours postoperatively.
Title
patient satisfaction
Description
1:3 with 1: very satisfied to 3: very unsatified
Time Frame
First 24 hours postoperatively.
Title
Incidence of local anesthetic toxicity
Description
yes or no
Time Frame
First 24 hours postoperatively.
Title
Visual Analog score
Description
0 - 10 with 0: no pain and 10: worst pain
Time Frame
4 hours after operation
Title
Visual Analog score
Description
0 - 10 with 0: no pain and 10: worst pain
Time Frame
12 hours after operation
Title
Visual Analog score
Description
0 - 10 with 0: no pain and 10: worst pain
Time Frame
24 hours after operation
Other Pre-specified Outcome Measures:
Title
Age
Description
in years
Time Frame
1 hour preoperatively
Title
Height
Description
in centimeter
Time Frame
1 hour preoperatively
Title
weight
Description
in kilogram
Time Frame
1 hour preoperatively
Title
Sex
Description
Female or Male
Time Frame
1 hour postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 - 65 years, American Society of Anesthesiologists physical status classification Ι and ΙΙ; scheduled for ankle and foot surgery Exclusion Criteria: Major hepatic severe renal impairment (creatinine > 3 or on dialysis); severe cardiovascular disease (ejection fraction < 35%) local infection at site of injection Any contraindication for ESP Known allergy to any drug used in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar S Fargahly, MD
Organizational Affiliation
Fayoum University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rana A Abdel ghaffar, MD
Organizational Affiliation
Fayoum University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed F Algyar, MD
Organizational Affiliation
Kafr Elshiekh University
Official's Role
Study Director
Facility Information:
Facility Name
Fayoum University hospital
City
Madīnat al Fayyūm
State/Province
Faiyum Governorate
ZIP/Postal Code
63514
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34188648
Citation
Diwan S, Nair A. Lumbar erector spinae plane block obtunding knee and ankle reflexes. Saudi J Anaesth. 2021 Apr-Jun;15(2):222-224. doi: 10.4103/sja.SJA_79_20. Epub 2021 Apr 1.
Results Reference
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Erector Spinae Plane Block and Ankle and Foot Surgery

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