Erector Spinae Plane Block and Ankle and Foot Surgery

NCT ID: NCT05708742

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-09-01

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).

Conditions

Pain; Ankle Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control group

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.

Group Type: SHAM_COMPARATOR

Ultrasound

Intervention Type: 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.

saline solution

Intervention Type: DRUG

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

Needle

Intervention Type: 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.

ESP group

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.

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: 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.

Bupivacaine Hydrochloride

Intervention Type: DRUG

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

Needle

Intervention Type: 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.

Interventions

Ultrasound

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: DEVICE

Bupivacaine Hydrochloride

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

Intervention Type: DRUG

saline solution

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

Intervention Type: DRUG

Needle

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.

Intervention Type: DEVICE

Other Intervention Names

Linear transducer; Local anesthetic; Saline isotonic 0.9%

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fayoum University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Hamed

Associate professor of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar S Fargahly, MD

Role: STUDY_CHAIR

Fayoum University

Rana A Abdel ghaffar, MD

Role: STUDY_DIRECTOR

Fayoum University

Mohamed F Algyar, MD

Role: STUDY_DIRECTOR

Kafr Elshiekh University

Locations

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 34188648 (View on PubMed)

Other Identifiers

D295

Identifier Type: -

Identifier Source: org_study_id