PainNCT05708742
Erector Spinae Plane Block and Ankle and Foot Surgery
A study testing Ultrasound, Bupivacaine Hydrochloride and saline solution in people with Pain and Ankle Injuries, run by Fayoum University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Ankle Injuries
- What is being tested?
- Ultrasound, Bupivacaine Hydrochloride and saline solution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years, American Society of Anesthesiologists physical status classification Ι and ΙΙ; scheduled for ankle and foot surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Fayoum University hospital
El Fayoum Qesm, Faiyum Governorate, 63514
About this study
Official title: The Analgesic Efficacy of Erector Spinae Plane Block in Ankle and Foot Surgery: A Randomized Controlled Study
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.
Read more
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.
Read the 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
- Being tested
- Ultrasound, Bupivacaine Hydrochloride, saline solution, Needle
- Keywords
- Erector spinae block, Ankle and foot surgery, Postoperative analgesia
- Medical subject headings
- Pain, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Also called Linear transducer
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 HydrochlorideDrug
Also called Local anesthetic
The ESP block group underwent US-guided ESP block at L4 vertebrae level with 20 ml of bupivacaine 0.25%.
saline solutionDrug
Also called Saline isotonic 0.9%
The control group underwent the same procedure but had a sham injection (20 ml of saline).
NeedleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Ultrasound; Drug: Bupivacaine Hydrochloride; Device: Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog score
0 - 10 with 0: no pain and 10: worst pain
Measured: 8 hours after operation
Secondary outcomes (9)
Total opioid consumption
in milligram
Measured: First 24 hours postoperatively.
time to first analgesic request
from end of operation to request of analgesia due to pain
Measured: First 24 hours postoperatively.
Incidence of nausea
yes or no
Measured: First 24 hours postoperatively.
Incidence of vomiting
yes or no
Measured: First 24 hours postoperatively.
patient satisfaction
1:3 with 1: very satisfied to 3: very unsatified
Measured: First 24 hours postoperatively.
Incidence of local anesthetic toxicity
yes or no
Measured: First 24 hours postoperatively.
Visual Analog score
0 - 10 with 0: no pain and 10: worst pain
Measured: 4 hours after operation
Visual Analog score
0 - 10 with 0: no pain and 10: worst pain
Measured: 12 hours after operation
Visual Analog score
0 - 10 with 0: no pain and 10: worst pain
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Jan 2023
- Primary completion15 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University Hospital
- Investigators
- Omar S Fargahly, MD, Study chair, Fayoum UniversityRana A Abdel ghaffar, MD, Study director, Fayoum UniversityMohamed F Algyar, MD, Study director, Kafr Elshiekh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708742
- Sponsor's protocol ID
- D295
- Status last verified
- Oct 2023
- First submitted
- 24 Jan 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34188648
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Erector Spinae Plane Block in Ankle and Foot Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05708742
- Acronym / sponsor ID
- D295
- Conditions
- Pain, Ankle Injuries
- Keywords
- Erector spinae block, Ankle and foot surgery, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Device: Ultrasound, Drug: saline solution, Device: NeedleThe 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. |
| ESP group | Experimental | Device: Ultrasound, Drug: Bupivacaine Hydrochloride, Device: NeedleThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 - 65 years, American Society of Anesthesiologists physical status classification Ι and ΙΙ; scheduled for ankle and foot surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundAlso: Linear transducerA 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. | Device | Control group, ESP group |
| Bupivacaine HydrochlorideAlso: Local anestheticThe ESP block group underwent US-guided ESP block at L4 vertebrae level with 20 ml of bupivacaine 0.25%. | Drug | ESP group |
| saline solutionAlso: Saline isotonic 0.9%The control group underwent the same procedure but had a sham injection (20 ml of saline). | Drug | Control group |
| NeedleA 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. | Device | Control group, ESP group |
Primary outcome
Visual Analog score
Time frame: 8 hours after operation
0 - 10 with 0: no pain and 10: worst pain
9 secondary outcomes
Total opioid consumption
Time frame: First 24 hours postoperatively.
time to first analgesic request
Time frame: First 24 hours postoperatively.
Incidence of nausea
Time frame: First 24 hours postoperatively.
Incidence of vomiting
Time frame: First 24 hours postoperatively.
patient satisfaction
Time frame: First 24 hours postoperatively.
Incidence of local anesthetic toxicity
Time frame: First 24 hours postoperatively.
Visual Analog score
Time frame: 4 hours after operation
Visual Analog score
Time frame: 12 hours after operation
Visual Analog score
Time frame: 24 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Background: PubMed 34188648Diwan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar S Fargahly, MD study chair
Fayoum University
Rana A Abdel ghaffar, MD study director
Fayoum University
Mohamed F Algyar, MD study director
Kafr Elshiekh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound, Bupivacaine Hydrochloride and saline solution in people with Pain and Ankle Injuries, run by Fayoum University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog score (time frame: 8 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.