GynecomastiaNCT04425447
Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block in Gynecomastia Surgery
A study testing Tumescent local anesthesia, Thoracic paravertebral block and Thoracic interfascial plane block in people with Gynecomastia and Thoracic Interfascial Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
The growing increase in the number of gynecomastia surgeries has resulted in an increased need for anesthetic techniques with improved pain reduction, safety, and fewer complications. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Gynecomastia, Thoracic Interfascial Plane Block, Thoracic Paravertebral Block
- What is being tested?
- Tumescent local anesthesia, Thoracic paravertebral block and Thoracic interfascial plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2020to 31 Dec 2021
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 up to 65 years
- Male gender only
- ASA physical status I and II
- Weight 75-100 kg
- Duration of surgery ≤ 2 hours
- Scheduled for elective idiopathic gynecomastia surgery
Who cannot join
- Patient refusal.
- Uncooperative patients.
- Known hypersensitivity to local anesthetic (LA) (bupivacaine).
- Local infection at the site of injection (TPVB or TIPB).
- Coagulopathy.
- History of opioid abuse or chronic analgesic use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block for Anesthesia in Gynecomastia Surgery: A Randomized Controlled Trial
The growing increase in the number of gynecomastia surgeries has resulted in an increased need for anesthetic techniques with improved pain reduction, safety, and fewer complications.
The aim of this work is to compare the efficacy of ultrasound guided thoracic interfascial plane block and ultrasound guided thoracic paravertebral block for anesthesia in gynecomastia surgery.
Read the detailed description
This prospective randomized open label clinical trial will be carried out on 90 male patients undergoing elective idiopathic gynecomastia surgery in Tanta University Hospitals.
Study design:
Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes:
Group C: 30 patients will receive bilateral tumescent local anesthesia as a control group.
Group TPVB: 30 patients will receive bilateral US guided thoracic paravertebral block.
Group TIPB: 30 patients will receive bilateral US guided thoracic interfascial plane block.
- Being tested
- Tumescent local anesthesia, Thoracic paravertebral block, Thoracic interfascial plane block
- Medical subject headings
- Gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumescent local anesthesiaDrug
Surgical disinfection of the area will be performed, skin infiltration with 2 mL of 1% lidocaine will be done, and wetting fluid will be used (1000 ml normal saline, 20 ml lidocaine 2%, and 1 mg epinephrine).
Infiltration will be initiated with a 25-gauge needle. The 25-gauge needles cause little discomfort and provide enough local anesthesia to allow painless, more complete infiltration using a 20-gauge spinal needle. After the glandular nipple tissue is made somewhat tumescent, a larger (20-gauge) spinal needle can be more easily passed through the otherwise dense and resistant tissue.
Thoracic paravertebral blockDrug
The paravertebral block (PVB) will be performed in the sitting position. Surgical disinfection of the thoracic paravertebral area will be done. A linear high-frequency transducer will be used. The scanning process (longitudinal out-of-plane technique) will be started at 5 to 10 cm lateral to the spinous process to identify the rounded ribs and parietal pleura underneath. The transducer is then moved progressively more medially until transverse processes are identified as more squared structure and deeper to the ribs. Once the transverse processes will be identified, skin infiltration with 2 mL of 1% lidocaine will be done. A 100-mm, 22 G needle will be inserted out of the plane to contact the transverse process and then walk off the transverse process 1 to 1.5 cm deeper searching for loss of resistance to inject 20 mL (5mL lidocaine 2% and 15 mL bupivacaine 0.25%) at each level of T4.
Thoracic interfascial plane blockDrug
Total LA injected was 80 mL (10 mL lidocaine 2% and 70 mL bupivacaine 0.25%) The linear probe will be placed below the outer third of the clavicle to detect anatomical landmarks, such as the serratus anterior muscle (SAM), external intercostal muscle (EIM), pectoralis muscles, thoracoacromial artery, and second rib. A test bolus of 1-2 ml of LA will be injected; upon confirmation of diffusion of the test dose between the external intercostal muscles and the SAM, a total of 20 ml of LA will be injected. The needle will be then carefully moved in the direction of the third and fourth ribs while confirming the expansion of the fascial plane.
In the performance of the pecto-intercostal fascial plane block (PIFB), a probe will be placed parallel to the long axis of the sternum at a distance greater than 2 cm from the attachment of the second rib and sternum to identify the pectoralis muscles, EIM, and second rib. A
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | 30 patients will receive bilateral tumescent local anesthesia as a control group Receives: Drug: Tumescent local anesthesia |
| Group TPVB | Experimental | 30 patients will receive bilateral US guided thoracic paravertebral block. Receives: Drug: Thoracic paravertebral block |
| Group TIPB | Experimental | 30 patients will receive bilateral US guided thoracic interfascial plane block Receives: Drug: Thoracic interfascial plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of intraoperative fentanyl requirement (mg)
If the patient complains from pain, fentanyl 25μg intravenously will be administrated.
Measured: 3 hours
Secondary outcomes (1)
Degree of patient's satisfaction
Patient satisfaction before discharge using a 5- point score, with (0 = very dissatisfied, 1 = dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied).
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start20 Jun 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecomastiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taysser Mahmoud Abdalraheem, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425447
- Sponsor's protocol ID
- 33793/4/20
- Status last verified
- Apr 2023
- First submitted
- 8 Jun 2020
- Last updated
- 20 Apr 2023
- Results posted
- 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 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block for Anesthesia in Gynecomastia Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04425447
- Acronym / sponsor ID
- 33793/4/20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Jun 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.
The growing increase in the number of gynecomastia surgeries has resulted in an increased need for anesthetic techniques with improved pain reduction, safety, and fewer complications.
The aim of this work is to compare the efficacy of ultrasound guided thoracic interfascial plane block and ultrasound guided thoracic paravertebral block for anesthesia in gynecomastia surgery.
Detailed description
This prospective randomized open label clinical trial will be carried out on 90 male patients undergoing elective idiopathic gynecomastia surgery in Tanta University Hospitals.
Study design:
Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes:
Group C: 30 patients will receive bilateral tumescent local anesthesia as a control group.
Group TPVB: 30 patients will receive bilateral US guided thoracic paravertebral block.
Group TIPB: 30 patients will receive bilateral US guided thoracic interfascial plane block.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Drug: Tumescent local anesthesia30 patients will receive bilateral tumescent local anesthesia as a control group |
| Group TPVB | Experimental | Drug: Thoracic paravertebral block30 patients will receive bilateral US guided thoracic paravertebral block. |
| Group TIPB | Experimental | Drug: Thoracic interfascial plane block30 patients will receive bilateral US guided thoracic interfascial plane block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 up to 65 years
- Male gender only
- ASA physical status I and II
- Weight 75-100 kg
- Duration of surgery ≤ 2 hours
Key exclusion criteria (6 listed)
- Patient refusal.
- Uncooperative patients.
- Known hypersensitivity to local anesthetic (LA) (bupivacaine).
- Local infection at the site of injection (TPVB or TIPB).
- Coagulopathy.
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 |
|---|---|---|
| Tumescent local anesthesiaSurgical disinfection of the area will be performed, skin infiltration with 2 mL of 1% lidocaine will be done, and wetting fluid will be used (1000 ml normal saline, 20 ml lidocaine 2%, and 1 mg epinephrine). Infiltration will be initiated with a 25-gauge needle. The 25-gauge needles cause little discomfort and provide enough local anesthesia to allow painless, more complete infiltration using a 20-gauge spinal needle. After the glandular nipple tissue is made somewhat tumescent, a larger (20-gauge) spinal needle can be more easily passed through the otherwise dense and resistant tissue. | Drug | Group C |
| Thoracic paravertebral blockThe paravertebral block (PVB) will be performed in the sitting position. Surgical disinfection of the thoracic paravertebral area will be done. A linear high-frequency transducer will be used. The scanning process (longitudinal out-of-plane technique) will be started at 5 to 10 cm lateral to the spinous process to identify the rounded ribs and parietal pleura underneath. The transducer is then moved progressively more medially until transverse processes are identified as more squared structure and deeper to the ribs. Once the transverse processes will be identified, skin infiltration with 2 mL of 1% lidocaine will be done. A 100-mm, 22 G needle will be inserted out of the plane to contact the transverse process and then walk off the transverse process 1 to 1.5 cm deeper searching for loss of resistance to inject 20 mL (5mL lidocaine 2% and 15 mL bupivacaine 0.25%) at each level of T4. | Drug | Group TPVB |
| Thoracic interfascial plane blockTotal LA injected was 80 mL (10 mL lidocaine 2% and 70 mL bupivacaine 0.25%) The linear probe will be placed below the outer third of the clavicle to detect anatomical landmarks, such as the serratus anterior muscle (SAM), external intercostal muscle (EIM), pectoralis muscles, thoracoacromial artery, and second rib. A test bolus of 1-2 ml of LA will be injected; upon confirmation of diffusion of the test dose between the external intercostal muscles and the SAM, a total of 20 ml of LA will be injected. The needle will be then carefully moved in the direction of the third and fourth ribs while confirming the expansion of the fascial plane. In the performance of the pecto-intercostal fascial plane block (PIFB), a probe will be placed parallel to the long axis of the sternum at a distance greater than 2 cm from the attachment of the second rib and sternum to identify the pectoralis muscles, EIM, and second rib. A | Drug | Group TIPB |
Primary outcome
The amount of intraoperative fentanyl requirement (mg)
Time frame: 3 hours
If the patient complains from pain, fentanyl 25μg intravenously will be administrated.
1 secondary outcome
Degree of patient's satisfaction
Time frame: 6 hours
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 20 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumescent local anesthesia, Thoracic paravertebral block and Thoracic interfascial plane block in people with Gynecomastia and Thoracic Interfascial Plane Block, 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 6 inclusion and 6 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 20 Apr 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 amount of intraoperative fentanyl requirement (mg) (time frame: 3 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 20 Apr 2023.