Postoperative PainNCT04085263
Rhomboid Intercostal and Subserratus Plane Block
A study testing Rhomboid intercostal and subserratus plane block group in people with Postoperative Pain and Regional Anesthesia Morbidity, run by Tanta University at 1 site in Egypt.
Trial summary
This clinical trial will be conducted at Tanta University Hospitals, General Surgery Hospitals on female patients undergoing radical mastectomy . All the patients will receive general anesthesia. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Postoperative Pain, Regional Anesthesia Morbidity
- What is being tested?
- Rhomboid intercostal and subserratus plane block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 6 Sep 2022
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients
- Aged 40-75 years
- ASA class I-II
- Presented for elective radical mastectomy.
Who cannot join
- Patients refused to participate.
- Patients with known or suspected allergy to the used medication.
- Patients with preoperative chronic pain
- Patients received preoperative opioids or gabapentoids.
- Patients with major cardiac, renal, respiratory, or hepatic disease.
- Patients with potential risk of 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 Rhomboid Intercostal and Subserratus Plane Block on the Postoperative Analgesia of Patients Undergoing Radical Mastectomy: Randomized Controlled Study
This clinical trial will be conducted at Tanta University Hospitals, General Surgery Hospitals on female patients undergoing radical mastectomy
. All the patients will receive general anesthesia.
Read more
The patients will be randomly allocated into one of the following two groups;- - Control group (30 patients): The patients in this group will receive sham rhomboid intercostal and subserratus plane.
- Rhomboid intercostal and subserratus plane block group (30 patients): The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
The primary outcome measure will be the total dose of morphine consumed in the first 24 h after surgery and the secondary outcome will be the postoperative pain score.
Read the detailed description
This prospective randomized controlled study will be carried out on female patients who will be presented for radical mastectomy in the general surgery department in Tanta university hospitals over three 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 minimal risk of local hematoma that which will be managed by adequate compression and minimal risk of infection that will be guarded against by adequate sterilization and prophylactic antibiotic.
There will be adequate supervision to maintain the privacy of patients and confidentiality of data.
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.
Upon arrival of the patient 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; - • Control group (30 patients): The patients in this group will receive sham rhomboid intercostal and subserratus plane.
- Rhomboid intercostal and subserratus plane block group (30 patients): The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
Anesthesia will be induced by fentanyl 1 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 32-36 mmhg. Anesthesia will be maintained by isoflurane 1% MAC 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
- Postoperative Pain, Regional Anesthesia Morbidity
- Being tested
- Control group, Rhomboid intercostal and subserratus plane block group
- Keywords
- Radical Mastectomy, Postoperative pain, Morphine consumption, subserratus plane 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.
Control groupProcedure or surgery
Also called Sham block group
The patients in this group will receive sham rhomboid intercostal and subserratus plane.
Rhomboid intercostal and subserratus plane block groupProcedure or surgery
Also called Experimental group
The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | The patients in this group will receive sham rhomboid intercostal and subserratus plane. Receives: Procedure: Control group |
| Rhomboid intercostal and subserratus plane block group | Experimental | The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane. Receives: Procedure: Rhomboid intercostal and subserratus plane block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The postoperative morphine consumprtion
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 postoperative pain score
The postoperative Visual analogue score
Measured: The first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Sep 2019
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Mohamed shebl Abdelghany
- 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
- NCT04085263
- Sponsor's protocol ID
- 33206/07/19
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2019
- Last updated
- 13 Sep 2022
- 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 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rhomboid Intercostal and Subserratus Plane Block on the Postoperative Analgesia of Patients Undergoing Radical Mastectomy: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04085263
- Acronym / sponsor ID
- 33206/07/19
- Conditions
- Postoperative Pain, Regional Anesthesia Morbidity
- Keywords
- Radical Mastectomy, Postoperative pain, Morphine consumption, subserratus plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Dr. Mohamed shebl Abdelghany
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 11 Sep 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 trial will be conducted at Tanta University Hospitals, General Surgery Hospitals on female patients undergoing radical mastectomy
. All the patients will receive general anesthesia.
The patients will be randomly allocated into one of the following two groups;- - Control group (30 patients): The patients in this group will receive sham rhomboid intercostal and subserratus plane.
- Rhomboid intercostal and subserratus plane block group (30 patients): The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
The primary outcome measure will be the total dose of morphine consumed in the first 24 h after surgery and the secondary outcome will be the postoperative pain score.
Detailed description
This prospective randomized controlled study will be carried out on female patients who will be presented for radical mastectomy in the general surgery department in Tanta university hospitals over three 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 minimal risk of local hematoma that which will be managed by adequate compression and minimal risk of infection that will be guarded against by adequate sterilization and prophylactic antibiotic.
There will be adequate supervision to maintain the privacy of patients and confidentiality of data.
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.
Upon arrival of the patient 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; - • Control group (30 patients): The patients in this group will receive sham rhomboid intercostal and subserratus plane.
- Rhomboid intercostal and subserratus plane block group (30 patients): The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
Anesthesia will be induced by fentanyl 1 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 32-36 mmhg. Anesthesia will be maintained by isoflurane 1% MAC 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 |
|---|---|---|
| Control group | Sham comparator | Procedure: Control groupThe patients in this group will receive sham rhomboid intercostal and subserratus plane. |
| Rhomboid intercostal and subserratus plane block group | Experimental | Procedure: Rhomboid intercostal and subserratus plane block groupThe patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients
- Aged 40-75 years
- ASA class I-II
- Presented for elective radical mastectomy.
Key exclusion criteria (8 listed)
- Patients refused to participate.
- Patients with known or suspected allergy to the used medication.
- Patients with preoperative chronic pain
- Patients received preoperative opioids or gabapentoids.
- Patients with major cardiac, renal, respiratory, or hepatic disease.
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 |
|---|---|---|
| Control groupAlso: Sham block groupThe patients in this group will receive sham rhomboid intercostal and subserratus plane. | Procedure or surgery | Control group |
| Rhomboid intercostal and subserratus plane block groupAlso: Experimental groupThe patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane. | Procedure or surgery | Rhomboid intercostal and subserratus plane block group |
Primary outcome
The postoperative morphine consumprtion
Time frame: The first 24 hours 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 postoperative pain score
Time frame: The first 24 hours postoperatively
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 13 Sep 2022.
- Individual participant dataSharing planned: No. Once the study had been successfully completed, the data will be shared for other researchers.
Related trials for Postoperative Pain
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Recruiting
Post Operative Pain and Vagal Stimulation
Rectal Surgery, Pain (Visceral, Somatic, or Neuropathic)
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 Rhomboid intercostal and subserratus plane block group in people with Postoperative Pain and Regional Anesthesia Morbidity, 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 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 13 Sep 2022. 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?
The postoperative morphine consumprtion (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 13 Sep 2022.