Erector Spinae Plane Block and Ankle and Foot Surgery

NCT05708742 | Completed

• 1 other identifier: D295
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Ankle Injuries

Keywords

Erector spinae block; Ankle and foot surgery; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Visual Analog score

  0 - 10 with 0: no pain and 10: worst pain

  8 hours after operation

Secondary Outcomes (9)

• Total opioid consumption

  First 24 hours postoperatively.

• time to first analgesic request

  First 24 hours postoperatively.

• Incidence of nausea

  First 24 hours postoperatively.

• Incidence of vomiting

  First 24 hours postoperatively.

• patient satisfaction

  First 24 hours postoperatively.

Other Outcomes (4)

• Age

  1 hour preoperatively

• Height

  1 hour preoperatively

• weight

  1 hour preoperatively

Study Arms (2)

Control group

SHAM COMPARATOR

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.

Device: Ultrasound; Drug: saline solution; Device: Needle

ESP group

EXPERIMENTAL

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.

Device: Ultrasound; Drug: Bupivacaine Hydrochloride; Device: Needle

Interventions

Bupivacaine Hydrochloride DRUG

The ESP block group underwent US-guided ESP block at L4 vertebrae level with 20 ml of bupivacaine 0.25%.

Also known as: Local anesthetic

ESP group

saline solution DRUG

The control group underwent the same procedure but had a sham injection (20 ml of saline).

Also known as: Saline isotonic 0.9%

Control group

Needle DEVICE

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.

Control group; ESP group

Ultrasound DEVICE

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.

Also known as: Linear transducer

Control group; ESP group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 65 years, American Society of Anesthesiologists physical status classification Ι and ΙΙ; scheduled for ankle and foot surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34188648 BACKGROUND

MeSH Terms

Conditions

Pain; Ankle Injuries

Interventions

Ultrasonography; Bupivacaine; Anesthetics, Local; Saline Solution; Needles

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Equipment and Supplies

Study Officials

• Omar S Fargahly, MD

  Fayoum University

  STUDY CHAIR

• Rana A Abdel ghaffar, MD

  Fayoum University

  STUDY DIRECTOR

• Mohamed F Algyar, MD

  Kafr Elshiekh University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Apart from the anesthesiologists who performed the blocks, all patients, surgeons, and postoperative nurses remained blinded to randomization throughout the study period.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesia

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 1, 2023
• Study Start: January 1, 2023
• Primary Completion: August 15, 2023
• Study Completion: September 1, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)