Post Operative PainNCT05771116
Erector Spinae Catheter Versus Paravertebral Catheter for Postoperative Analgesia in Cancer Patients Post Mastectomies
A study testing ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK: and PARAVERTEBRAL BLOCK: in people with Post Operative Pain, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
All patients admitted in National Cancer institute, Cairo University for breast surgeries will be investigated for inclusion criteria in the current study. And will be enrolled if fulfilled the criteria into 2 groups .70 patients will be included in this prospective randomized study. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK: and PARAVERTEBRAL BLOCK:
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 15 Jul 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .Physical status ASA II.
- . Patients (age 20-70yrs) scheduled for breast surgeries for breast cancer under general anesthesia
Who cannot join
- .History of psychological disorders.
- Known sensitivity or contraindication to local anesthetics.
- Localized infection at the site of block.
- patients with coagulopathy or an (INR ≥ 2)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
NCIEgypt
Cairo, 11796
suzan adlan, lecturer, 01111068300, dr_s.adlan@hotmail.com
About this study
Official title: Erector Spinae Catheter Versus Paravertebral Catheter for Pain Management in Modified Radical Mastectomy for Cancer Patients: A Randomized Double-Blind Non-inferiority Trial
All patients admitted in National Cancer institute, Cairo University for breast surgeries will be investigated for inclusion criteria in the current study. And will be enrolled if fulfilled the criteria into 2 groups
.70 patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)
- All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving general anesthesia
- Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic
Read the detailed description
- 70patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)
- All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving GA
- Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic.
- Random numbers were generated using a computer-generated randomization code and were sealed in an opaque envelope. Randomization was conducted by a person who was not involved in the study.
- An independent observer who was blind to the group assignment checked the intraoperative and postoperative data.
- VAS pain score immediately postoperative and at 2,4,6, 8,12,18,24,36 ,48hrs.postoperative.
- Conditions
- Post Operative Pain
- Being tested
- ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:, PARAVERTEBRAL BLOCK:
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:Procedure or surgery
catheter will be placed for ERECTOR SPINAE PLANE BLOCK
PARAVERTEBRAL BLOCK:Procedure or surgery
catheter will be placed for PARAVERTEBRAL BLOCK
| Study group | Role | What they receive |
|---|---|---|
| Erecto Spinae Plane Block group | Active comparator | a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The skin will be anaesthetized using 3ml of 2% Lidocaine. A 20-gauge block needle will be inserted in-plane in a cephalad-to-caudad direction to place the tip into the fascial plane on the deep (anterior) aspect of erector spinaemuscle;20ml bupivacaine 0.25% will be injected. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process The needle will be removed and the catheter secured with adhesive. Receives: Procedure: ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:; Procedure: PARAVERTEBRAL BLOCK: |
| the paravertebral group | Active comparator | After identification of the transverse process, internal intercostal membrane (IIM), and pleura at the T3 and T6 levels, an out-of-plane needle guidance technique was used to perform the PVB.The success of both blocks will be confirmed by loss of pinprick sensation on the dermatomal site of the block
•blocks will be activated ,After negative aspiration, 0.5 ml/kg 0.25% bupivacaine (max 20 ml) will be injected. Afterwards, a 20 gauge peripheral nerve catheter will be easily threaded into the space. The needle will be removed and the catheter secured with adhesive. Receives: Procedure: ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:; Procedure: PARAVERTEBRAL BLOCK: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 48 hours Post-operative opioid consumption to keep VAS score ≤4.
the VAS score rating, in which 0 = "no pain" and 10 = "worst possible pain". both during rest and movement
Measured: 48 hours postoperative
Secondary outcomes (1)
1st request of analgesia
1st request of analgesia , any hemodynamic instability and complications
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Jan 2023
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- suzan adlan, lecturer, Principal investigator, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771116
- Sponsor's protocol ID
- AP2212-501-034
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Catheter Versus Paravertebral Catheter for Pain Management in Modified Radical Mastectomy for Cancer Patients: A Randomized Double-Blind Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05771116
- Acronym / sponsor ID
- AP2212-501-034
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 16 Mar 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.
All patients admitted in National Cancer institute, Cairo University for breast surgeries will be investigated for inclusion criteria in the current study. And will be enrolled if fulfilled the criteria into 2 groups
.70 patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)
- All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving general anesthesia
- Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic
Detailed description
- 70patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)
- All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving GA
- Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic.
- Random numbers were generated using a computer-generated randomization code and were sealed in an opaque envelope. Randomization was conducted by a person who was not involved in the study.
- An independent observer who was blind to the group assignment checked the intraoperative and postoperative data.
- VAS pain score immediately postoperative and at 2,4,6, 8,12,18,24,36 ,48hrs.postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erecto Spinae Plane Block group | Active comparator | Procedure: ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:, Procedure: PARAVERTEBRAL BLOCK:a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The skin will be anaesthetized using 3ml of 2% Lidocaine. A 20-gauge block needle will be inserted in-plane in a cephalad-to-caudad direction to place the tip into the fascial plane on the deep (anterior) aspect of erector spinaemuscle;20ml bupivacaine 0.25% will be injected. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process The needle will be removed and the catheter secured with adhesive. |
| the paravertebral group | Active comparator | Procedure: ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:, Procedure: PARAVERTEBRAL BLOCK:After identification of the transverse process, internal intercostal membrane (IIM), and pleura at the T3 and T6 levels, an out-of-plane needle guidance technique was used to perform the PVB.The success of both blocks will be confirmed by loss of pinprick sensation on the dermatomal site of the block •blocks will be activated ,After negative aspiration, 0.5 ml/kg 0.25% bupivacaine (max 20 ml) will be injected. Afterwards, a 20 gauge peripheral nerve catheter will be easily threaded into the space. The needle will be removed and the catheter secured with adhesive. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- .Physical status ASA II.
- . Patients (age 20-70yrs) scheduled for breast surgeries for breast cancer under general anesthesia
Key exclusion criteria (4 listed)
- .History of psychological disorders.
- Known sensitivity or contraindication to local anesthetics.
- Localized infection at the site of block.
- patients with coagulopathy or an (INR ≥ 2)
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 BLOCK and PARAVERTEBRAL BLOCK:catheter will be placed for ERECTOR SPINAE PLANE BLOCK | Procedure or surgery | Erecto Spinae Plane Block group, the paravertebral group |
| PARAVERTEBRAL BLOCK:catheter will be placed for PARAVERTEBRAL BLOCK | Procedure or surgery | Erecto Spinae Plane Block group, the paravertebral group |
Primary outcome
Total 48 hours Post-operative opioid consumption to keep VAS score ≤4.
Time frame: 48 hours postoperative
the VAS score rating, in which 0 = "no pain" and 10 = "worst possible pain". both during rest and movement
1 secondary outcome
1st request of analgesia
Time frame: 48 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- 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.
suzan adlan, lecturer principal investigator
National Cancer Institute, Egypt
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 PARAVERTEBRAL BLOCK: and PARAVERTEBRAL BLOCK: in people with Post Operative Pain, run by National Cancer Institute, Egypt 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 2 inclusion and 4 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 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact suzan adlan, lecturer (01111068300, dr_s.adlan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total 48 hours Post-operative opioid consumption to keep VAS score ≤4. (time frame: 48 hours postoperative). 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 Jul 2023.