Regional Anesthesia MorbidityNCT04162951
Retrolaminar Thoracic Paravertebral Block
A study testing Ordinary approach paravertebral block and Retrolaminar paravertebral block in people with Regional Anesthesia Morbidity and Postoperative Pain, run by Tanta University at 1 site in Egypt.
Trial summary
This clinical study will be conducted on female patients admitted to The General Surgery Department of Tanta Faculty of Medicine for a period of 9 months. Patients will be randomly allocated into one of the following two groups;- • Ordinary approach group (30 patients): The patients in this group will receive ordinary… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Regional Anesthesia Morbidity, Postoperative Pain
- What is being tested?
- Ordinary approach paravertebral block and Retrolaminar paravertebral 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
- 10 Nov 2019to 19 Oct 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients
- Aged 40-60 years
- ASA class I-II.
- Presented for elective breast surgery.
Who cannot join
- Patients refused to participate
- Patients with known or suspected or known allergy to the used medication.
- Patients with spinal deformities.
- Patients with preoperative chronic pain,
- Patients received preoperative opioids or gabapentoids.
- Patients with major cardiac, renal, respiratory, or hepatic disease.
Show all 9Show fewer
- Patients with suspected or diagnosed coagulopathy
- Uncooperative patients.
- Obese patients with BMI >36
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Retrolaminar Thoracic Paravertebral Block on the Postoperative Analgesia of Patients Undergoing Breast Surgeries: Prospective Randomized Double Blinded Study
This clinical study will be conducted on female patients admitted to The General Surgery Department of Tanta Faculty of Medicine for a period of 9 months.
Patients will be randomly allocated into one of the following two groups;- • Ordinary approach group (30 patients): The patients in this group will receive ordinary ultrasound-guided thoracic paravertebral block.
- Retro-laminar approach group (30 patients): The patients in this group will be receive real ultrasound-guided Retrolaminar thoracic paravertebral block.
All the patients will receive general anesthesia with attachment to a monitor (5 ASA Monitoring) In addition to bispectral index.
Read the detailed description
This prospective randomized controlled study will be carried out on female patients who will be presented for breast surgery in the General Surgery Department in Tanta university hospitals over 3 month duration and 6 months follow up that starts immediately after obtaining ethical committee approval, an informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.
Any unexpected risks that will appear during the research will be announced to the participants and to the ethical committee at time and adequate measures will be taken to resolve and avoid these risks.
Expected risks to the patients: patients enrolled in this study will have a very minimal risk of pleural puncture that will be managed by adequate observation and chest tube insertion whenever indicated. They may have a minimal risk of hypotension that will be managed by intravenous fluids and intravenous ephedrine 10 mg.
There will be adequate supervision to maintain the privacy of patients and confidentiality of data that will be used in the current study only.
There will be no conflict of interest, nor conflict with religion, law, or society standards.
The research will be beneficial to the society and has no risk of environmental pollution.
Once the patients will arrive to the operating room, intravascular access will be established, fluid preload will be started, and basic monitor will be attached. After positioning and adequate sterilization of the back. The patients will be randomly allocated into two equal groups by the aid of computer-generated software of randomization; - • Ordinary approach group (30 patients): The patients in this group will receive ordinary ultrasound-guided thoracic paravertebral block.
- Retro-laminar approach group (30 patients): The patients in this group will be receive real ultrasound-guided Retrolaminar thoracic paravertebral block.
Anesthesia will be induced by fentanyl 1.5 ug/kg, propofol 1.5 mg/kg, and cis-atracurium 0.15 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to a mechanical ventilator with its parameters adjusted to maintain etCo2 34-38 mmhg. Anesthesia will be maintained by isoflurane 1.5% in mixture of oxygen:air 1:1 with the use of low flow (1 ml/min).
All the patients will be connected to a bispectral index monitor with maintaining its value ranging 40-60. Increase in the BIS value over 60 will be managed by additional dose of fentanyl 1ug/kg till decrease the BIS below 60. If the BIS is still over 60, increasing the isoflurane 0.2 % MAC till it decreased below 60.
At the end of the surgery, switching off the inhalational anesthetics, reversal of muscle relaxation, and awake tracheal extubation will be done with transporting the patients to the PACU for postoperative follow up and monitoring.
- Conditions
- Regional Anesthesia Morbidity, Postoperative Pain
- Being tested
- Ordinary approach paravertebral block, Retrolaminar paravertebral block
- Keywords
- Retrolaminar, Paravertebral, Breast surgery, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ordinary approach paravertebral blockProcedure or surgery
Also called thoracic paravvertebral blovk
Ultrasound guided thoracic paravertebral block. At the appropriate dermatome, the needle (22-gauge, 8-10-cm, short bevelled spinal needle, or a Touhy needle if a catheter is to be placed) is inserted 2.5-3 cm lateral to the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process at a variable depth (2-4 cm) depending on the build of the individual. The needle is then walked above the transverse process and gradually advanced until a loss of resistance to air or saline, or a subtle 'click' is felt as the superior costotransverse ligament is penetrated, usually within 1-1.5 cm from the superior edge of the transverse process.
Retrolaminar paravertebral blockProcedure or surgery
Also called Thoracic retrolaminar paravertebral block
In the retrolaminar approach to TPVB or retrolaminar block (RB), local anesthetic (LA) is injected into the retrolaminar plane to achieve a truncal sensory block like that of traditional TPVB. It has been postulated that during RB, LA spreads from the injection plane to the thoracic paravertebral space (TPVS) through the superior costotransverse ligament (SCTL). Retrolaminar block will be performed under ultrasound guidance, as a single injection.
| Study group | Role | What they receive |
|---|---|---|
| Ordinary approach group | Experimental | The patients in this group will receive ordinary ultrasound-guided thoracic paravertebral block. by local anesthetic mixture at a volume of 0.2 ml/kg composed of plain bupivacaine 0.25% and Fentanyl 2 ug/ml. Receives: Procedure: Ordinary approach paravertebral block |
| Retro-laminar approach group | Experimental | The patients in this group will be receive real ultrasound-guided Retrolaminar thoracic paravertebral block by local anesthetic mixture at a volume of 0.2 ml/kg composed of plain bupivacaine 0.25% and Fentanyl 2 ug/ml. Receives: Procedure: Retrolaminar paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The postoperative rescue analgesia consumption
Morphine consumption in the first 24 h postoperatively (3 mg morphine i.v will be given when the postoperative VAS score was 4 or more considering the total dose consumption in the first postoperative day not exceeding 15 mg.
Measured: The first 24 hours postoperatively
Secondary outcomes (1)
The incidence of complications
The incidence of complication pleural puncture, pneumothorax, hypotension, or intravascular injection .
Measured: up 24 hours from performing the technique
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start10 Nov 2019
- Primary completion19 Oct 2023
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective study
- 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 Ismaiel, M.D, Principal investigator, Lecturer of Anesthesia and Intensive Care, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162951
- Sponsor's protocol ID
- 33207/07/19
- Status last verified
- Oct 2023
- First submitted
- 9 Sep 2019
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the study had been successfully completed, the data will be shared for other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Retrolaminar Thoracic Paravertebral Block on the Postoperative Analgesia of Patients Undergoing Breast Surgeries: Prospective Randomized Double Blinded Study
- ClinicalTrials.gov ID
- NCT04162951
- Acronym / sponsor ID
- 33207/07/19
- Conditions
- Regional Anesthesia Morbidity, Postoperative Pain
- Keywords
- Retrolaminar, Paravertebral, Breast surgery, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 14 Nov 2019 (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 clinical study will be conducted on female patients admitted to The General Surgery Department of Tanta Faculty of Medicine for a period of 9 months.
Patients will be randomly allocated into one of the following two groups;- • Ordinary approach group (30 patients): The patients in this group will receive ordinary ultrasound-guided thoracic paravertebral block.
- Retro-laminar approach group (30 patients): The patients in this group will be receive real ultrasound-guided Retrolaminar thoracic paravertebral block.
All the patients will receive general anesthesia with attachment to a monitor (5 ASA Monitoring) In addition to bispectral index.
Detailed description
This prospective randomized controlled study will be carried out on female patients who will be presented for breast surgery in the General Surgery Department in Tanta university hospitals over 3 month duration and 6 months follow up that starts immediately after obtaining ethical committee approval, an informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.
Any unexpected risks that will appear during the research will be announced to the participants and to the ethical committee at time and adequate measures will be taken to resolve and avoid these risks.
Expected risks to the patients: patients enrolled in this study will have a very minimal risk of pleural puncture that will be managed by adequate observation and chest tube insertion whenever indicated. They may have a minimal risk of hypotension that will be managed by intravenous fluids and intravenous ephedrine 10 mg.
There will be adequate supervision to maintain the privacy of patients and confidentiality of data that will be used in the current study only.
There will be no conflict of interest, nor conflict with religion, law, or society standards.
The research will be beneficial to the society and has no risk of environmental pollution.
Once the patients will arrive to the operating room, intravascular access will be established, fluid preload will be started, and basic monitor will be attached. After positioning and adequate sterilization of the back. The patients will be randomly allocated into two equal groups by the aid of computer-generated software of randomization; - • Ordinary approach group (30 patients): The patients in this group will receive ordinary ultrasound-guided thoracic paravertebral block.
- Retro-laminar approach group (30 patients): The patients in this group will be receive real ultrasound-guided Retrolaminar thoracic paravertebral block.
Anesthesia will be induced by fentanyl 1.5 ug/kg, propofol 1.5 mg/kg, and cis-atracurium 0.15 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to a mechanical ventilator with its parameters adjusted to maintain etCo2 34-38 mmhg. Anesthesia will be maintained by isoflurane 1.5% in mixture of oxygen:air 1:1 with the use of low flow (1 ml/min).
All the patients will be connected to a bispectral index monitor with maintaining its value ranging 40-60. Increase in the BIS value over 60 will be managed by additional dose of fentanyl 1ug/kg till decrease the BIS below 60. If the BIS is still over 60, increasing the isoflurane 0.2 % MAC till it decreased below 60.
At the end of the surgery, switching off the inhalational anesthetics, reversal of muscle relaxation, and awake tracheal extubation will be done with transporting the patients to the PACU for postoperative follow up and monitoring.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective study
| Arm | Type | Receives |
|---|---|---|
| Ordinary approach group | Experimental | Procedure: Ordinary approach paravertebral blockThe patients in this group will receive ordinary ultrasound-guided thoracic paravertebral block. by local anesthetic mixture at a volume of 0.2 ml/kg composed of plain bupivacaine 0.25% and Fentanyl 2 ug/ml. |
| Retro-laminar approach group | Experimental | Procedure: Retrolaminar paravertebral blockThe patients in this group will be receive real ultrasound-guided Retrolaminar thoracic paravertebral block by local anesthetic mixture at a volume of 0.2 ml/kg composed of plain bupivacaine 0.25% and Fentanyl 2 ug/ml. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients
- Aged 40-60 years
- ASA class I-II.
- Presented for elective breast surgery.
Key exclusion criteria (9 listed)
- Patients refused to participate
- Patients with known or suspected or known allergy to the used medication.
- Patients with spinal deformities.
- Patients with preoperative chronic pain,
- Patients received preoperative opioids or gabapentoids.
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 |
|---|---|---|
| Ordinary approach paravertebral blockAlso: thoracic paravvertebral blovkUltrasound guided thoracic paravertebral block. At the appropriate dermatome, the needle (22-gauge, 8-10-cm, short bevelled spinal needle, or a Touhy needle if a catheter is to be placed) is inserted 2.5-3 cm lateral to the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process at a variable depth (2-4 cm) depending on the build of the individual. The needle is then walked above the transverse process and gradually advanced until a loss of resistance to air or saline, or a subtle 'click' is felt as the superior costotransverse ligament is penetrated, usually within 1-1.5 cm from the superior edge of the transverse process. | Procedure or surgery | Ordinary approach group |
| Retrolaminar paravertebral blockAlso: Thoracic retrolaminar paravertebral blockIn the retrolaminar approach to TPVB or retrolaminar block (RB), local anesthetic (LA) is injected into the retrolaminar plane to achieve a truncal sensory block like that of traditional TPVB. It has been postulated that during RB, LA spreads from the injection plane to the thoracic paravertebral space (TPVS) through the superior costotransverse ligament (SCTL). Retrolaminar block will be performed under ultrasound guidance, as a single injection. | Procedure or surgery | Retro-laminar approach group |
Primary outcome
The postoperative rescue analgesia consumption
Time frame: The first 24 hours postoperatively
Morphine consumption in the first 24 h postoperatively (3 mg morphine i.v will be given when the postoperative VAS score was 4 or more considering the total dose consumption in the first postoperative day not exceeding 15 mg.
1 secondary outcome
The incidence of complications
Time frame: up 24 hours from performing the technique
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 24 Oct 2023.
- Individual participant dataSharing planned: No. Once the study had been successfully completed, the data will be shared for other researchers.
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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.
Sameh Ismaiel, M.D principal investigator
Lecturer of Anesthesia and Intensive Care, 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 Ordinary approach paravertebral block and Retrolaminar paravertebral block in people with Regional Anesthesia Morbidity and Postoperative Pain, 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 4 inclusion and 9 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 24 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. 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?
The postoperative rescue analgesia consumption (time frame: The first 24 hours postoperatively). 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 24 Oct 2023.