Erector Spinae Block AnalgesiaPhase 1NCT04315454
Aalgesic Efficacy of Erector -Spinae Technique With Levobupvicaine in Patients Undergoing Upper Abdominal Cancer Surgery
A Phase 1 study testing Levobupivacaine in people with Erector Spinae Block Analgesia, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
To study analgesic efficacy \&safety of bilateral erector spinae block for upper abdominal cancer surgery as apart of multimodal analgesia. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Erector Spinae Block Analgesia
- What is being tested?
- Levobupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to Apr 2021
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient subjected to major upper abdominal cancer surgery.
- The enrolled age will be from 18-70 years old.
- ASA: I-III, NYHA: I-III.
Who cannot join
- ASA \& physical status (NYHA) > III.
- Pregnant women.
- Body mass index >40 kg/m2.
- Pre-operative opioid consumption.
- Contraindication or patient's refusal of the procedure.
- Un co-operative patient.
- Coagulopathy, skin infection, significant organ dysfunction or drug allergy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt Cancer Institute
Asyut, 171516
Romany G. Rezk, MSc, 1094521156 ext. 0020, romanygamal1986@gmail.com
About this study
Official title: The Analgesic Efficacy of Erector -Spinae Technique With Levobupvicaine in Patients Undergoing Upper Abdominal Cancer Surgery
To study analgesic efficacy \&safety of bilateral erector spinae block for upper abdominal cancer surgery as apart of multimodal analgesia.
Read the detailed description
Patients will be randomly assigned using computer generated randomization program (http://www.randomizer.org) into two groups, each group of the them consist of 15 patients:
GROUP (A): {CONTROL GROUP} Patient will receive 20 ml of normal saline into interfascial plane between rhomboidus major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side .
Group (B):
Patient will receive 20 mg 0.25% Levobupivacaine bilaterally as above 10 mg each side.
Preoperatively \& post-operatively procedures:
Premedication will be given after complete fasting hours \&after applying standard monitors (non invasive blood pressure, pulse oximetery, ECG, temperature and capnography, an intra-venous 16 gauge cannula will be inserted and secured).
Ultrasound guided Erector spinae plane block with patient in the sitting position \& skin of the upper back is prepared with 2% chlorhexidine solution. Counting down from c7,the spine of T7 is identified it is corresponding to the tip the scapular spine ,a high frequency ultrasound probe is placed across T7 spine then probe move slowly laterally to identify transverse process of T7 ,So probe is moved to a vertical alignment and erector spinae muscle is visualized lying underneath the trapezius muscle.
Needle gauge will be inserted then 10 ml Levobupivacaine into interfascial plane between rhomboid major \& erector spinae muscle in each side.
General anesthesia will be induced with Fentanyl 0.5 μg/kg, Propofol 2mg/kg, muscle relaxant (Atracurium 0.5 mg /kg) , inhalational anesthesia ( Isoflurane 1-1.5 MAC-or-sevoflurane2-3MAC ) as maintenance of anesthesia with frequent muscle relaxant every 20 minutes to maintain heart rate (HR) and blood pressure within 20% of the basal value. Patients were mechanically ventilated to maintain end tidal (ETCO2) between 35-40 mmHg. The inspired oxygen fraction (FIO2) was 0.5 using oxygen-and-air mixtures with frequent monitoring intraoperatively every 30 minutes, IV fentanyl infusion at rate of 0.1 μg/kg/hr may be used if needed.
Non steroidal anti-inflammatory as ketobrufen will be given intraoperatively at dose of (0.5-0.75mg/kg)then postoperatively every eight hours at the same dose.
The reverse of muscle relaxant with safe extubation will be done at the end of surgery.
-PCA morphine 2mg within five minutes lock out interval will be given postoperatively when there is pain.
- Conditions
- Erector Spinae Block Analgesia
- Being tested
- Levobupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
A group of patients will receive 20 ml of normal saline into the interfascial plane between rhomboids major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side, the other group of patients will receive 20 mg 0.25% Levobupivacaine bilaterally as above 10 mg each side.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | patients will receive 20 ml of normal saline into interfascial plane between rhomboids major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side. Receives: Drug: Levobupivacaine |
| Group B | Experimental | Patients will receive 20 mg 0.25% Levobupivacaine into the interfascial plane between rhomboids major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side. Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
Decrease morphine consumption.
Measured: 24 hours
Secondary outcomes (4)
VAS score
Intensity of pain at rest and during pain-provoking movements (deep breathing,coughing, mobilization) measured by VAS pain score immediately postoperative then at 2, 4 ,6 ,12\& 24 hours after surgery}
Measured: 24 hours
patient satisfaction
patient satisfaction in the first 24 hour post operatively.
Measured: 24 hours
Hemodynamic
- Hemodynamic variables including (systolic and diastolic BP, heart rate, oxygen saturation \& respiratory rate) measured preoperatively (baseline measurement) then immediately postoperative and at 2, 4 ,6 ,12\& 24 hours after surgery.
Measured: 24 hours
blood gas
-Blood gases will be drawn preoperatively and at 12 hour interval in the PACU for assessment of Oxygen tension (PO2) \& Co2 tension (PCO2).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Jun 2019
- Primary completionDec 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Block AnalgesiaStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romany Gamal Rezk Bakeet, South Egypt Cancer Institute
- Investigators
- Romany G. Rezk, MSc, Principal investigator, Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315454
- Sponsor's protocol ID
- southECI-1
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: as we should ask patients and take their consents to share these date
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Erector -Spinae Technique With Levobupvicaine in Patients Undergoing Upper Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT04315454
- Acronym / sponsor ID
- southECI-1
- Conditions
- Erector Spinae Block Analgesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 19 Mar 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.
To study analgesic efficacy \&safety of bilateral erector spinae block for upper abdominal cancer surgery as apart of multimodal analgesia.
Detailed description
Patients will be randomly assigned using computer generated randomization program (http://www.randomizer.org) into two groups, each group of the them consist of 15 patients:
GROUP (A): {CONTROL GROUP} Patient will receive 20 ml of normal saline into interfascial plane between rhomboidus major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side .
Group (B):
Patient will receive 20 mg 0.25% Levobupivacaine bilaterally as above 10 mg each side.
Preoperatively \& post-operatively procedures:
Premedication will be given after complete fasting hours \&after applying standard monitors (non invasive blood pressure, pulse oximetery, ECG, temperature and capnography, an intra-venous 16 gauge cannula will be inserted and secured).
Ultrasound guided Erector spinae plane block with patient in the sitting position \& skin of the upper back is prepared with 2% chlorhexidine solution. Counting down from c7,the spine of T7 is identified it is corresponding to the tip the scapular spine ,a high frequency ultrasound probe is placed across T7 spine then probe move slowly laterally to identify transverse process of T7 ,So probe is moved to a vertical alignment and erector spinae muscle is visualized lying underneath the trapezius muscle.
Needle gauge will be inserted then 10 ml Levobupivacaine into interfascial plane between rhomboid major \& erector spinae muscle in each side.
General anesthesia will be induced with Fentanyl 0.5 μg/kg, Propofol 2mg/kg, muscle relaxant (Atracurium 0.5 mg /kg) , inhalational anesthesia ( Isoflurane 1-1.5 MAC-or-sevoflurane2-3MAC ) as maintenance of anesthesia with frequent muscle relaxant every 20 minutes to maintain heart rate (HR) and blood pressure within 20% of the basal value. Patients were mechanically ventilated to maintain end tidal (ETCO2) between 35-40 mmHg. The inspired oxygen fraction (FIO2) was 0.5 using oxygen-and-air mixtures with frequent monitoring intraoperatively every 30 minutes, IV fentanyl infusion at rate of 0.1 μg/kg/hr may be used if needed.
Non steroidal anti-inflammatory as ketobrufen will be given intraoperatively at dose of (0.5-0.75mg/kg)then postoperatively every eight hours at the same dose.
The reverse of muscle relaxant with safe extubation will be done at the end of surgery.
-PCA morphine 2mg within five minutes lock out interval will be given postoperatively when there is pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: Levobupivacainepatients will receive 20 ml of normal saline into interfascial plane between rhomboids major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side. |
| Group B | Experimental | Drug: LevobupivacainePatients will receive 20 mg 0.25% Levobupivacaine into the interfascial plane between rhomboids major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient subjected to major upper abdominal cancer surgery.
- The enrolled age will be from 18-70 years old.
- ASA: I-III, NYHA: I-III.
Key exclusion criteria (7 listed)
- ASA \& physical status (NYHA) > III.
- Pregnant women.
- Body mass index >40 kg/m2.
- Pre-operative opioid consumption.
- Contraindication or patient's refusal of the procedure.
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 |
|---|---|---|
| LevobupivacaineA group of patients will receive 20 ml of normal saline into the interfascial plane between rhomboids major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side, the other group of patients will receive 20 mg 0.25% Levobupivacaine bilaterally as above 10 mg each side. | Drug | Group A, Group B |
Primary outcome
morphine consumption
Time frame: 24 hours
Decrease morphine consumption.
4 secondary outcomes
VAS score
Time frame: 24 hours
patient satisfaction
Time frame: 24 hours
Hemodynamic
Time frame: 24 hours
blood gas
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: Undecided. as we should ask patients and take their consents to share these date
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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.
Romany G. Rezk, MSc principal investigator
Specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levobupivacaine in people with Erector Spinae Block Analgesia, run by South Egypt Cancer Institute 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Mar 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romany G. Rezk, MSc (1094521156 ext. 0020, romanygamal1986@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine consumption (time frame: 24 hours). 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 19 Mar 2020.