MastectomyNCT06410378
s Serratus Anterior Block for Perioperative Analgesia
A study testing Erector Spinae Plane Block and Serratus Anterior Plane Block in people with Mastectomy and Postoperative Pain, run by Zagazig University at 1 site in Egypt.
Trial summary
Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimised, as in a number of women it may chronically persist for months in the form of postmastectomy pain syndrome. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Mastectomy, Postoperative Pain
- What is being tested?
- Erector Spinae Plane Block and Serratus Anterior Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2024to 1 Aug 2024
- 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 21 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent from the patient.
- Age: 21 - 60 years old.
- Gender: female patients.
- Body mass index: < 35 kg/m2.
- Physical status: ASA grade I-II (American society of anesthiologists).
- Type of operation: unilateral modified radical mastectomy operation.
Who cannot join
- • Patient with known history of allergy to study drugs.
- Chronic use of analgesics or drug dependence.
- Patients not able to understand pain assessment test.
- Anatomical abnormalities.
- Neuropathic disease.
- Pregnancy or breast feeding.
- Other contraindication of regional anesthesia e.g. septic focus at site of injection.
- patient with coagulopathy or on anticoagulant therapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig
Zagazig, MD, 44519
Asmaa M Galal Eldin, MD, 01200726092 ext. 002, asmaa.galal79@gmail.com
sara H Yousif, master, 01015051856 ext. 002, Saraheikal10@gmail.com
About this study
Official title: Ultrasound-Guided Erector Spinae Block Versus Serratus Anterior Block for Perioperative Analgesia In Patients Undergoing Modified Radical Mastectomy Surgery
Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimised, as in a number of women it may chronically persist for months in the form of postmastectomy pain syndrome.
Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as paravertebral block and thoracic epidural anathesia has possible complications and technical difficulties.
The new alternative regional techniques such as erector spinae plane block and serratus anterior plane block are clinical trials for providing a safe, easy and painless anesthetic procedure with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opiods consumption and subsequently avoid opiod-related adverse effects.
Read the detailed description
Breast cancer is the most common malignancy of women all over the world. Unfortunately, two-thirds of women who undergo breast cancer surgery are reported to develop chronic pain in the postoperative period. Surgery type, radiation therapy, and clinically acute pain are the most important risk factors for the development of more intense chronic pain.
With improved diagnostic techniques and treatment regimens, prognosis in breast cancer is improving, with the 5-year survival of patients diagnosed with primary breast cancer having increased to approximately 85%. Persistent post-surgical pain states in this group is reported in 30-50% of patients, up to half of whom may have pain well beyond 5 years. Over one-third of patients who underwent breast cancer surgery have inadequately controlled acute post-operative pain.
There are several ways to manage pain after mastectomy. Common systemic medications, particularly opioids, have different side effects, such as itching, nausea, vomiting and respiratory depression. Non-steroidal anti-inflammatory drugs are associated with impaired renal function and hemorrhagic disorders.
Regional anesthesia has been believed as one of the formats for effective perioperative pain control. Regional blocks using ultrasound-guide has become a perfect supplement to general anesthesia for extending analgesia after modified radical mastectomy. The advantage includes post-operative pain relief prolongation, a decrease in analgesic requirement post-operatively, a reduction in nausea and vomiting scores and probability for ambulatory discharge and hospital stay.
The complex innervation of breast tissues poses a great challenge for the anesthesiologists to provide adequate perioperative analgesia by ultrasound guided regional blocks. Thoracic epidural, interscalene brachial plexus block, paravertebral block, pectoral nerve I and pectoral nerve II blocks have been used in different studies with good results. There are also technically simple regional blocks as ultrasound-guided Serratus anterior Plane (US-guided SAP) block and erector spinae plane (US-guided ESP) block which can be used effectively for this purpose.
Forero et al. described ultrasound-guided Erector Spinae Plane (US-ESP) block as a novel analgesic technique in which local anesthetic injection is done beneath the erector spinae muscle. Previous studies reported effective postoperative pain reduction with ESP block after radical mastectomy surgery. Nevertheless, few studies have compared the efficacy of ESP block with another block technique.
The Serratus Anterior Plane block (SAP) provides anterolateral and partial posterior thoracic wall analgesia, affecting dermatomes from T2 to T9. SAP is affecting predominantly the lateral cutaneous branches of the thoracic intercostal nerves, along with intercostobrachial, thoracodorsal and long thoracic nerves. The block is performed further posteriorly and caudally than Pectoral Nerve Block-2, where the target nerves are located between the serratus anterior and the latissimus dorsi muscles.
- Conditions
- Mastectomy, Postoperative Pain
- Being tested
- Erector Spinae Plane Block, Serratus Anterior Plane Block, controll group
- Keywords
- Erector Spinae Block, Serratus anterior Block, Perioperative Analgesia
- 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 BlockProcedure or surgery
Also called Group E
Patient will receive 20 ml of bupivacaine 0.25 % through Erector Spinae Plane Block approach
Serratus Anterior Plane BlockProcedure or surgery
Also called Group S
Patient will receive 20 ml of bupivacaine 0.25 % through Serratus Anterior Plane Block approach.
controll groupProcedure or surgery
Also called Group C
patient will receive general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | patient place in sitting position. Type of needle Using 22-gauge spinal needle 10 cm Linear ultrasound probe is placed in a longitudinal parasagittal orientation 3 cm lateral to the T5 spinous process.
The erector spinae muscle is identified superficial to the tip of The T5 transverse process.
Needle insertion The needle is inserted in- plane superior to inferior approach. The tip of the needle is placed into the fascial plane on the deep aspect of erector spinae muscle.
The location of the needle tip is confirmed by visible normal saline fluid spread separating erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging .
Local anesthetic and volume Injection of 20 ml of bupivacaine 0.25 %. Receives: Procedure: Erector Spinae Plane Block |
| Serratus Anterior Plane Block: | Active comparator | The patient lies supine with placing the ipsi-lateral upper limb in abduction at 90° positio Using 22-gauge spinal needle 10 cm length. After skin sterilization, Ultrasound device with high frequency [9-12] and superficial linear probe that is first placed inferior to the middle of the clavicle and moved laterally and downward to locate the 1st rib where pectoralis major and pectoralis minor muscles are identified at this US window.
The US probe is moved toward axilla till serratus anterior muscle is identified above 2nd, 3rd and 4th ribs. The transducer is held at a slightly oblique angle at the level of the 4th and 5th rib, with the upper edge supero-anterior and the lower edge infero-anterior.
Needle insertion After infiltration of the skin at puncture site with 3 ml of lidocaine 1%, the needle is inserted inplane between the anterior serratus and the latissimus dorsi muscle on the mid-axillary line.
Injection of 20 mL of 0.25% bupivacaine. Receives: Procedure: Serratus Anterior Plane Block |
| control group | Active comparator | patients will receive only general anesthesia for Modified Radical Mastectomy. Receives: Procedure: controll group |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of first analgesia requirement
first time patient asks rescue analgesia and total morphine consumption post-operative.
Measured: during 24 hours postoperative
Secondary outcomes (2)
onset of Sensory block.
time needed for onset of sensory block.
Measured: within 20 minutes after block
assessment of sensory block
quality and duration of block
Measured: within 8 hours after giving block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start10 May 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be divided randomly by a computer-generated randomization table into three equal groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Asmaa Mohammed Galal El-Deen, Zagazig University
- Investigators
- Halah I Zanfaly, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410378
- Sponsor's protocol ID
- ZagazigS
- Status last verified
- May 2024
- First submitted
- 18 Mar 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after the completion of the study and publication
Publications
Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.
PubMed 30396100Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
PubMed 23923989Eldemrdash AM, Abdelzaam EM: By Ultrasonic-Guided Erector Spinae Block, Thoracic Paravertebral Block versus Serratus Anterior Plane Block by Articaine with Adrenaline during Breast Surgery with General Anesthesia: A Comparative Study of Analgesic Effect Post-Operatively: Double Blind Randomized, Controlled Trial, Open Journal of Anesthesiology 2019; 9: 68-82.
FitzGerald S, Odor PM, Barron A, Pawa A. Breast surgery and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):95-110. doi: 10.1016/j.bpa.2019.03.003. Epub 2019 Apr 6.
PubMed 31272657Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Gad M, Abdelwahab K, Abdallah A, Abdelkhalek M, Abdelaziz M. Ultrasound-Guided Erector Spinae Plane Block Compared to Modified Pectoral Plane Block for Modified Radical Mastectomy Operations. Anesth Essays Res. 2019 Apr-Jun;13(2):334-339. doi: 10.4103/aer.AER_77_19.
PubMed 31198256Khemka R, Chakraborty A. Ultrasound-guided modified serratus anterior plane block for perioperative analgesia in breast oncoplastic surgery: A case series. Indian J Anaesth. 2019 Mar;63(3):231-234. doi: 10.4103/ija.IJA_752_18.
PubMed 30988539Metwally AA, Elfeky EM, Abo Elenain KM, Yousef IM: Scoring systems in Anesthesia. Nature and Science 2016; 14: 47-48.
Rahimzadeh P, Imani F, Faiz SHR, Boroujeni BV. Impact of the Ultrasound-Guided Serratus Anterior Plane Block on Post-Mastectomy Pain: A Randomised Clinical Study. Turk J Anaesthesiol Reanim. 2018 Sep;46(5):388-392. doi: 10.5152/TJAR.2018.86719. Epub 2018 Sep 4.
PubMed 30263863Ross VH, Pan PH, Owen MD, Seid MH, Harris L, Clyne B, Voltaire M, Eisenach JC. Neostigmine decreases bupivacaine use by patient-controlled epidural analgesia during labor: a randomized controlled study. Anesth Analg. 2009 Aug;109(2):524-31. doi: 10.1213/ane.0b013e31819518e4. Epub 2009 Apr 17.
PubMed 19377050Singh S, Kumar G, Akhileshwar. Ultrasound-guided erector spinae plane block for postoperative analgesia in modified radical mastectomy: A randomised control study. Indian J Anaesth. 2019 Mar;63(3):200-204. doi: 10.4103/ija.IJA_758_18.
PubMed 30988534Swami SS, Keniya VM, Ladi SD, Rao R. Comparison of dexmedetomidine and clonidine (alpha2 agonist drugs) as an adjuvant to local anaesthesia in supraclavicular brachial plexus block: A randomised double-blind prospective study. Indian J Anaesth. 2012 May;56(3):243-9. doi: 10.4103/0019-5049.98767.
PubMed 22923822
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Erector Spinae Block Versus Serratus Anterior Block for Perioperative Analgesia In Patients Undergoing Modified Radical Mastectomy Surgery
- ClinicalTrials.gov ID
- NCT06410378
- Acronym / sponsor ID
- ZagazigS
- Conditions
- Mastectomy, Postoperative Pain
- Keywords
- Erector Spinae Block, Serratus anterior Block, Perioperative Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 13 May 2024 (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.
Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimised, as in a number of women it may chronically persist for months in the form of postmastectomy pain syndrome.
Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as paravertebral block and thoracic epidural anathesia has possible complications and technical difficulties.
The new alternative regional techniques such as erector spinae plane block and serratus anterior plane block are clinical trials for providing a safe, easy and painless anesthetic procedure with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opiods consumption and subsequently avoid opiod-related adverse effects.
Detailed description
Breast cancer is the most common malignancy of women all over the world. Unfortunately, two-thirds of women who undergo breast cancer surgery are reported to develop chronic pain in the postoperative period. Surgery type, radiation therapy, and clinically acute pain are the most important risk factors for the development of more intense chronic pain.
With improved diagnostic techniques and treatment regimens, prognosis in breast cancer is improving, with the 5-year survival of patients diagnosed with primary breast cancer having increased to approximately 85%. Persistent post-surgical pain states in this group is reported in 30-50% of patients, up to half of whom may have pain well beyond 5 years. Over one-third of patients who underwent breast cancer surgery have inadequately controlled acute post-operative pain.
There are several ways to manage pain after mastectomy. Common systemic medications, particularly opioids, have different side effects, such as itching, nausea, vomiting and respiratory depression. Non-steroidal anti-inflammatory drugs are associated with impaired renal function and hemorrhagic disorders.
Regional anesthesia has been believed as one of the formats for effective perioperative pain control. Regional blocks using ultrasound-guide has become a perfect supplement to general anesthesia for extending analgesia after modified radical mastectomy. The advantage includes post-operative pain relief prolongation, a decrease in analgesic requirement post-operatively, a reduction in nausea and vomiting scores and probability for ambulatory discharge and hospital stay.
The complex innervation of breast tissues poses a great challenge for the anesthesiologists to provide adequate perioperative analgesia by ultrasound guided regional blocks. Thoracic epidural, interscalene brachial plexus block, paravertebral block, pectoral nerve I and pectoral nerve II blocks have been used in different studies with good results. There are also technically simple regional blocks as ultrasound-guided Serratus anterior Plane (US-guided SAP) block and erector spinae plane (US-guided ESP) block which can be used effectively for this purpose.
Forero et al. described ultrasound-guided Erector Spinae Plane (US-ESP) block as a novel analgesic technique in which local anesthetic injection is done beneath the erector spinae muscle. Previous studies reported effective postoperative pain reduction with ESP block after radical mastectomy surgery. Nevertheless, few studies have compared the efficacy of ESP block with another block technique.
The Serratus Anterior Plane block (SAP) provides anterolateral and partial posterior thoracic wall analgesia, affecting dermatomes from T2 to T9. SAP is affecting predominantly the lateral cutaneous branches of the thoracic intercostal nerves, along with intercostobrachial, thoracodorsal and long thoracic nerves. The block is performed further posteriorly and caudally than Pectoral Nerve Block-2, where the target nerves are located between the serratus anterior and the latissimus dorsi muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The patients will be divided randomly by a computer-generated randomization table into three equal groups
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Procedure: Erector Spinae Plane Blockpatient place in sitting position. Type of needle Using 22-gauge spinal needle 10 cm Linear ultrasound probe is placed in a longitudinal parasagittal orientation 3 cm lateral to the T5 spinous process. The erector spinae muscle is identified superficial to the tip of The T5 transverse process. Needle insertion The needle is inserted in- plane superior to inferior approach. The tip of the needle is placed into the fascial plane on the deep aspect of erector spinae muscle. The location of the needle tip is confirmed by visible normal saline fluid spread separating erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging . Local anesthetic and volume Injection of 20 ml of bupivacaine 0.25 %. |
| Serratus Anterior Plane Block: | Active comparator | Procedure: Serratus Anterior Plane BlockThe patient lies supine with placing the ipsi-lateral upper limb in abduction at 90° positio Using 22-gauge spinal needle 10 cm length. After skin sterilization, Ultrasound device with high frequency [9-12] and superficial linear probe that is first placed inferior to the middle of the clavicle and moved laterally and downward to locate the 1st rib where pectoralis major and pectoralis minor muscles are identified at this US window. The US probe is moved toward axilla till serratus anterior muscle is identified above 2nd, 3rd and 4th ribs. The transducer is held at a slightly oblique angle at the level of the 4th and 5th rib, with the upper edge supero-anterior and the lower edge infero-anterior. Needle insertion After infiltration of the skin at puncture site with 3 ml of lidocaine 1%, the needle is inserted inplane between the anterior serratus and the latissimus dorsi muscle on the mid-axillary line. Injection of 20 mL of 0.25% bupivacaine. |
| control group | Active comparator | Procedure: controll grouppatients will receive only general anesthesia for Modified Radical Mastectomy. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent from the patient.
Key exclusion criteria (8 listed)
- • Patient with known history of allergy to study drugs.
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 BlockAlso: Group EPatient will receive 20 ml of bupivacaine 0.25 % through Erector Spinae Plane Block approach | Procedure or surgery | Erector Spinae Plane Block |
| Serratus Anterior Plane BlockAlso: Group SPatient will receive 20 ml of bupivacaine 0.25 % through Serratus Anterior Plane Block approach. | Procedure or surgery | Serratus Anterior Plane Block: |
| controll groupAlso: Group Cpatient will receive general anesthesia | Procedure or surgery | control group |
Primary outcome
time of first analgesia requirement
Time frame: during 24 hours postoperative
first time patient asks rescue analgesia and total morphine consumption post-operative.
2 secondary outcomes
onset of Sensory block.
Time frame: within 20 minutes after block
assessment of sensory block
Time frame: within 8 hours after giving block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 30396100Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.
- Background: PubMed 23923989Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
- BackgroundEldemrdash AM, Abdelzaam EM: By Ultrasonic-Guided Erector Spinae Block, Thoracic Paravertebral Block versus Serratus Anterior Plane Block by Articaine with Adrenaline during Breast Surgery with General Anesthesia: A Comparative Study of Analgesic Effect Post-Operatively: Double Blind Randomized, Controlled Trial, Open Journal of Anesthesiology 2019; 9: 68-82.
- Background: PubMed 31272657FitzGerald S, Odor PM, Barron A, Pawa A. Breast surgery and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):95-110. doi: 10.1016/j.bpa.2019.03.003. Epub 2019 Apr 6.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 31198256Gad M, Abdelwahab K, Abdallah A, Abdelkhalek M, Abdelaziz M. Ultrasound-Guided Erector Spinae Plane Block Compared to Modified Pectoral Plane Block for Modified Radical Mastectomy Operations. Anesth Essays Res. 2019 Apr-Jun;13(2):334-339. doi: 10.4103/aer.AER_77_19.
- Background: PubMed 30988539Khemka R, Chakraborty A. Ultrasound-guided modified serratus anterior plane block for perioperative analgesia in breast oncoplastic surgery: A case series. Indian J Anaesth. 2019 Mar;63(3):231-234. doi: 10.4103/ija.IJA_752_18.
- BackgroundMetwally AA, Elfeky EM, Abo Elenain KM, Yousef IM: Scoring systems in Anesthesia. Nature and Science 2016; 14: 47-48.
- Background: PubMed 30263863Rahimzadeh P, Imani F, Faiz SHR, Boroujeni BV. Impact of the Ultrasound-Guided Serratus Anterior Plane Block on Post-Mastectomy Pain: A Randomised Clinical Study. Turk J Anaesthesiol Reanim. 2018 Sep;46(5):388-392. doi: 10.5152/TJAR.2018.86719. Epub 2018 Sep 4.
- Background: PubMed 19377050Ross VH, Pan PH, Owen MD, Seid MH, Harris L, Clyne B, Voltaire M, Eisenach JC. Neostigmine decreases bupivacaine use by patient-controlled epidural analgesia during labor: a randomized controlled study. Anesth Analg. 2009 Aug;109(2):524-31. doi: 10.1213/ane.0b013e31819518e4. Epub 2009 Apr 17.
- Background: PubMed 30988534Singh S, Kumar G, Akhileshwar. Ultrasound-guided erector spinae plane block for postoperative analgesia in modified radical mastectomy: A randomised control study. Indian J Anaesth. 2019 Mar;63(3):200-204. doi: 10.4103/ija.IJA_758_18.
- Background: PubMed 22923822Swami SS, Keniya VM, Ladi SD, Rao R. Comparison of dexmedetomidine and clonidine (alpha2 agonist drugs) as an adjuvant to local anaesthesia in supraclavicular brachial plexus block: A randomised double-blind prospective study. Indian J Anaesth. 2012 May;56(3):243-9. doi: 10.4103/0019-5049.98767.
- Individual participant dataSharing planned: Yes. planned after the completion of the study and publication
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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.
Halah I Zanfaly, MD principal investigator
Zagazig 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 Erector Spinae Plane Block and Serratus Anterior Plane Block in people with Mastectomy and Postoperative Pain, run by Zagazig 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 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: status not confirmed, as of the sponsor's last update on 13 May 2024. 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 Asmaa M Galal Eldin, MD (01200726092 ext. 002, asmaa.galal79@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of first analgesia requirement (time frame: during 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06410378, which also lists 12 linked publications.
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 May 2024.