ERASNCT04586257
Effect of Regional Anesthesia on Enhanced Recovery After Spine Surgeries
A study testing Erector spinae plane block and Throacolumbar interfacial plane block in people with ERAS, run by Tanta University at 1 site in Egypt.
Trial summary
This study will be carried out on 80 patients who will be presented for different spine surgeries under general anesthesia and regional anesthesia technique in Tanta university hospitals. The study was approved by the research ethics committee of the faculty of medicine. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- ERAS
- What is being tested?
- Erector spinae plane block and Throacolumbar interfacial plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2020to 30 Mar 2024
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of both sexes aged (21-70 years) with ASA physical status I-III scheduled for spine surgeries.
Who cannot join
- Patient refusal
- Body mass index (BMI) less than 18 or higher than35 kg/m2
- Pregnant
- History of relevant allergy to related perioperative medications
- Previous lumbar spine surgery
- Existing contraindications to nerve block such as coagulopathy, local and systemic infection
- Hepatic or renal insufficiency
- Chronic opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Thoracolumbar Interfacial Plane Block or Erector Spinae Plane Block on the Enhanced Recovery After Spine Surgeries: Prospective Randomized Double-blind Study
This study will be carried out on 80 patients who will be presented for different spine surgeries under general anesthesia and regional anesthesia technique in Tanta university hospitals. The study was approved by the research ethics committee of the faculty of medicine.
Patients will be admitted to the OR where induction of general anesthesia was started and then, the patients will be randomly distributed into two equal groups; -
Read more
- Group I (40 patients) (ESP block): patients in this group will receive ESP block after induction of general anesthesia.
- Group II (40 patients) (TLIP block): patients in this group will receive TLIP block after induction of general anesthesia
Measurements; - The length of hospital stay as the primary outcome Postoperative pain scores and opioid consumption as the Secondary outcome
Read the detailed description
This prospective randomized double-blind study will be carried out on 80 adult patients who will be presented for different spine surgeries in Tanta university hospitals after obtaining the approval from the institutional Ethical Committee, informed written consent will be obtained from all the participants.
Patients will be randomly classified using a computer-generated software of randomization into 2 groups:
- Group I (40 patients) (ESP block): patients in this group will receive ESP block after induction of general anesthesia.
- Group II (40 patients) (TLIP block): patients in this group will receive TLIP block after induction of general anesthesia
Anesthetic technique
- The patients will be assessed preoperatively in the anesthesia clinic. On arrival of patients to the preparation room, an intravenous line will be established and the patient will be connected to a monitor. All the patients will receive pheniramine hydrogen maleate 45.5 mg intravenous as an antihistamine, Cefazolin30 mg/kg, and 40 mg pantoprazole.
- Induction of anesthesia will be carried out by fentanyl 1 ug/kg, propofol 1.5 mg/kg, and atracurium 0.5 mg/kg to facilitate tracheal intubation. After securing the airway through a suitable sized endotracheal tube, the patient was connected to a mechanical ventilator with its parameters adjusted to maintain the end-tidal carbon dioxide 34-38 mmHg.
- Maintenance of the anesthesia was performed by isoflurane 1.MAC and incremental doses of atracurium 0.1 mg/kg. A temperature probe was inserted in the nasopharynx for core temperature monitoring. The depth of anesthesia was monitored by the bispectral index (Covidien, Mansfield, MA, USA). The BIS values were kept 40-60. An additional bolus dose of fentanyl 0.5 ug/kg was used in case of increase BIS more than 60 or increase in the heart rate or mean arterial pressure by more than 15 % of the baseline values.
- All patients received tranexamic acid 30 mg/kg through intravenous infusion. Before skin incision, patients of group I will receive ultrasound-guided ESP block, while patients in group II will receive ultrasound guided TLIP block.
- At the end of the surgery, the isoflurane was switched off with reversal of muscle relaxation and awake tracheal extubation and transfer of the patient to the recovery room for postoperative monitoring and supplementation of oxygen through a nasal cannula (2-3 L/min). All the patients will receive 4 mg dexamethasone I .v after induction of anesthesia and 4 mg of ondansetron i.v at the end of the surgery to guard against postoperative nausea and vomiting. All the patients received routine postoperative analgesia in the form of paracetamol 1 gm i.v infusion every 6 hours and ketorolac 30 mg i.v every 12 hours. Rescue analgesia in the form of morphine 3 mg i.v was administrated when the pain score was more than 3.
- Conditions
- ERAS
- Being tested
- Erector spinae plane block, Throacolumbar interfacial plane block
- Keywords
- Spine surgery, Length of hospital stay, ERAS, Regional analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
While patients in the prone position, 1.4-5.1 MHz low-frequency probe (C5-1s convex transducer) will be first placed in a longitudinal orientation in the midline to identify the spinous process of at the appropriate lumbar level, then it will be scanned laterally about 2-3 cm until visualization of the paraspinal muscles and the transverse process at the same time. After standard sterilization, a 21-G short bevel nerve block needle will be advanced in a cephalad-to-caudal direction, in-plane under real- time ultrasound guidance, through skin, subcutaneous tissue, and erector spinae muscles until reaching the transverse process. After negative aspiration of blood or cerebral spinal fluid, a small volume of local anesthetic was injected to confirm the position of the needle tip between the erector spinae muscles and the transverse process. A total of 20 ml of 0.0.25% plain bupivacaine will be incrementally injected with intermittent negative aspiration on each side.
Throacolumbar interfacial plane blockProcedure or surgery
USG-guided TLIP block will be performed using a high-frequency linear probe while the patient in prone position. The probe will be covered with sterile sheath positioned transversally in a midline position at approximately the level of the 3rd lumbar vertebra (L3). The corresponding spinous process and interspinal muscles will be identified, and the probe will be slid laterally to identify the multifidus (MF) muscle and longissimus (LG) muscle. Sliding the probe from midline to laterally helps in the correct identification of various muscles. After identifying the muscles, TLIP block will be performed aseptically on both sides of L3 vertebra. Under ultrasound guidance, an insulated echogenic needle will be inserted in-plane in a lateral to medial orientation in-plane USG guided through the belly of LG toward the MF. When needle reach deep to middle of MF/LG interface, 20 ml 0.25% bupivacaine will be injected after negative aspiration. The block will be administered bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | patients in this group will receive Erector spinae plane block after induction of general anesthesia. Receives: Procedure: Erector spinae plane block |
| Group II | Experimental | patients in this group will receive thoracolumbar interfascial plane block after induction of general anesthesia Receives: Procedure: Throacolumbar interfacial plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay
The time interval in days from the day of the surgery till discharge of the patient from the hospital.
Measured: Within 7 days of the surgery
Secondary outcomes (2)
postoperative pain scores
Postoperative Numerical rating score (NRS) every 2 hours in the first six hours, then every 4 h till 24 h. When NRS scores reach 4 or more, 3 mg of i.v morphine will be given and can be repeated if required with calculation of the total postoperative morphine consumption in mg in the first 24 hours after surgery and the time to the first request of rescue analgesia
Measured: Within the first 24 hours after surgery
The postoperative opioid consumption
The total dose of morphine consumed in the first 24 hours after surgery
Measured: Within the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start15 Oct 2020
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
- Investigators
- Sameh Abdelkhalik, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586257
- Sponsor's protocol ID
- 34142/9/20
- Status last verified
- Apr 2024
- First submitted
- 7 Oct 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracolumbar Interfacial Plane Block or Erector Spinae Plane Block on the Enhanced Recovery After Spine Surgeries: Prospective Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT04586257
- Acronym / sponsor ID
- 34142/9/20
- Conditions
- ERAS
- Keywords
- Spine surgery, Length of hospital stay, ERAS, Regional analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 14 Oct 2020 (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.
This study will be carried out on 80 patients who will be presented for different spine surgeries under general anesthesia and regional anesthesia technique in Tanta university hospitals. The study was approved by the research ethics committee of the faculty of medicine.
Patients will be admitted to the OR where induction of general anesthesia was started and then, the patients will be randomly distributed into two equal groups; -
- Group I (40 patients) (ESP block): patients in this group will receive ESP block after induction of general anesthesia.
- Group II (40 patients) (TLIP block): patients in this group will receive TLIP block after induction of general anesthesia
Measurements; - The length of hospital stay as the primary outcome Postoperative pain scores and opioid consumption as the Secondary outcome
Detailed description
This prospective randomized double-blind study will be carried out on 80 adult patients who will be presented for different spine surgeries in Tanta university hospitals after obtaining the approval from the institutional Ethical Committee, informed written consent will be obtained from all the participants.
Patients will be randomly classified using a computer-generated software of randomization into 2 groups:
- Group I (40 patients) (ESP block): patients in this group will receive ESP block after induction of general anesthesia.
- Group II (40 patients) (TLIP block): patients in this group will receive TLIP block after induction of general anesthesia
Anesthetic technique
- The patients will be assessed preoperatively in the anesthesia clinic. On arrival of patients to the preparation room, an intravenous line will be established and the patient will be connected to a monitor. All the patients will receive pheniramine hydrogen maleate 45.5 mg intravenous as an antihistamine, Cefazolin30 mg/kg, and 40 mg pantoprazole.
- Induction of anesthesia will be carried out by fentanyl 1 ug/kg, propofol 1.5 mg/kg, and atracurium 0.5 mg/kg to facilitate tracheal intubation. After securing the airway through a suitable sized endotracheal tube, the patient was connected to a mechanical ventilator with its parameters adjusted to maintain the end-tidal carbon dioxide 34-38 mmHg.
- Maintenance of the anesthesia was performed by isoflurane 1.MAC and incremental doses of atracurium 0.1 mg/kg. A temperature probe was inserted in the nasopharynx for core temperature monitoring. The depth of anesthesia was monitored by the bispectral index (Covidien, Mansfield, MA, USA). The BIS values were kept 40-60. An additional bolus dose of fentanyl 0.5 ug/kg was used in case of increase BIS more than 60 or increase in the heart rate or mean arterial pressure by more than 15 % of the baseline values.
- All patients received tranexamic acid 30 mg/kg through intravenous infusion. Before skin incision, patients of group I will receive ultrasound-guided ESP block, while patients in group II will receive ultrasound guided TLIP block.
- At the end of the surgery, the isoflurane was switched off with reversal of muscle relaxation and awake tracheal extubation and transfer of the patient to the recovery room for postoperative monitoring and supplementation of oxygen through a nasal cannula (2-3 L/min). All the patients will receive 4 mg dexamethasone I .v after induction of anesthesia and 4 mg of ondansetron i.v at the end of the surgery to guard against postoperative nausea and vomiting. All the patients received routine postoperative analgesia in the form of paracetamol 1 gm i.v infusion every 6 hours and ketorolac 30 mg i.v every 12 hours. Rescue analgesia in the form of morphine 3 mg i.v was administrated when the pain score was more than 3.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: Erector spinae plane blockpatients in this group will receive Erector spinae plane block after induction of general anesthesia. |
| Group II | Experimental | Procedure: Throacolumbar interfacial plane blockpatients in this group will receive thoracolumbar interfascial plane block after induction of general anesthesia |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients of both sexes aged (21-70 years) with ASA physical status I-III scheduled for spine surgeries.
Key exclusion criteria (8 listed)
- Patient refusal
- Body mass index (BMI) less than 18 or higher than35 kg/m2
- Pregnant
- History of relevant allergy to related perioperative medications
- Previous lumbar spine surgery
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 |
|---|---|---|
| Erector spinae plane blockWhile patients in the prone position, 1.4-5.1 MHz low-frequency probe (C5-1s convex transducer) will be first placed in a longitudinal orientation in the midline to identify the spinous process of at the appropriate lumbar level, then it will be scanned laterally about 2-3 cm until visualization of the paraspinal muscles and the transverse process at the same time. After standard sterilization, a 21-G short bevel nerve block needle will be advanced in a cephalad-to-caudal direction, in-plane under real- time ultrasound guidance, through skin, subcutaneous tissue, and erector spinae muscles until reaching the transverse process. After negative aspiration of blood or cerebral spinal fluid, a small volume of local anesthetic was injected to confirm the position of the needle tip between the erector spinae muscles and the transverse process. A total of 20 ml of 0.0.25% plain bupivacaine will be incrementally injected with intermittent negative aspiration on each side. | Procedure or surgery | Group I |
| Throacolumbar interfacial plane blockUSG-guided TLIP block will be performed using a high-frequency linear probe while the patient in prone position. The probe will be covered with sterile sheath positioned transversally in a midline position at approximately the level of the 3rd lumbar vertebra (L3). The corresponding spinous process and interspinal muscles will be identified, and the probe will be slid laterally to identify the multifidus (MF) muscle and longissimus (LG) muscle. Sliding the probe from midline to laterally helps in the correct identification of various muscles. After identifying the muscles, TLIP block will be performed aseptically on both sides of L3 vertebra. Under ultrasound guidance, an insulated echogenic needle will be inserted in-plane in a lateral to medial orientation in-plane USG guided through the belly of LG toward the MF. When needle reach deep to middle of MF/LG interface, 20 ml 0.25% bupivacaine will be injected after negative aspiration. The block will be administered bilaterally. | Procedure or surgery | Group II |
Primary outcome
length of hospital stay
Time frame: Within 7 days of the surgery
The time interval in days from the day of the surgery till discharge of the patient from the hospital.
2 secondary outcomes
postoperative pain scores
Time frame: Within the first 24 hours after surgery
The postoperative opioid consumption
Time frame: Within the first 24 hours after surgery
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 16 Apr 2024.
- Individual participant dataSharing planned: Yes. The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
Related trials for ERAS
Recruiting
Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy
Thyroid Diseases, Ambulation Time
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
RecruitingPhase 4
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Pain, Post Operative Analgesia
RecruitingPhase 3
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Gynecologic Cancer, Anemia
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.
Sameh Abdelkhalik principal investigator
Tanta 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 Erector spinae plane block and Throacolumbar interfacial plane block in people with ERAS, run by Tanta University 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 8 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 16 Apr 2024. 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. 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?
length of hospital stay (time frame: Within 7 days of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2024.