Mastectomy PatientNCT07022353
Bi-level Erector Spinae Plane Block and Pre-emptive Oral Tizanidine for Analgesia After Mastectomy Surgery
A study testing Bilevel erector spinae plane block and tizanidine oral capsule in people with Mastectomy Patient, run by Mansoura University at 1 site in Egypt.
Trial summary
Effective management of postoperative pain in breast cancer surgery is essential to minimize the risk of developing postmastectomy pain syndrome.The aim of this study is to evaluate the effectiveness of combining bilevel erector spinae plane (ESP) block with a single preoperative oral dose of tizanidine in improving… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Mastectomy Patient
- What is being tested?
- Bilevel erector spinae plane block and tizanidine oral capsule
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2025to 30 Dec 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) ІІ patients.
- Scheduled for unilateral modified radical mastectomy.
- BMI levels between 18.5- 35 Kg/m2.
Who cannot join
- Patient's refusal.
- Altered mental status or un-cooperative patients.
- History of known sensitivity to the used anesthetics.
- Bleeding or coagulation diathesis.
- Infection or redness at the injection site.
- Cardiac, renal, hepatic, hematological disease, peptic ulcer, gastrointestinal bleeding, and central or peripheral neurological disease.
- Chronic pain.
- Participants used analgesics routinely within the last 24 h.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Bi-level Erector Spinae Plane Block and Pre-emptive Single-dose Oral Tizanidine for Postoperative Analgesia After Mastectomy Surgery: a Prospective, Randomized, Controlled Trial
Effective management of postoperative pain in breast cancer surgery is essential to minimize the risk of developing postmastectomy pain syndrome.The aim of this study is to evaluate the effectiveness of combining bilevel erector spinae plane (ESP) block with a single preoperative oral dose of tizanidine in improving postoperative analgesia in patients undergoing mastectomy surgery.
It is hypothesized that the combination of bilevel ESP block and single-dose oral tizanidine will provide superior postoperative analgesia compared to bilevel ESP block alone in patients undergoing mastectomy.
Read the detailed description
Introduction:
Effective management of postoperative pain in breast cancer surgery is essential to minimize the risk of developing postmastectomy pain syndrome, a chronic condition that significantly impacts patients' quality of life. Multimodal analgesia, which combines pharmacological and non-pharmacological strategies, has been shown to enhance postoperative pain control and reduce opioid consumption. In recent years, regional anesthesia techniques have become increasingly favored for perioperative pain management in breast surgeries. The ESP block has gained popularity due to its simplicity, safety profile, and effectiveness in thoracic and breast surgeries. Its analgesic action is attributed to the craniocaudal spread of local anesthetic into the costovertebral foramina and epidural space, resulting in blockade of both ventral and dorsal rami of the spinal nerves and providing unilateral thoracic analgesia.The bilevel ESP block, which involves administering the block at two distinct thoracic levels, has been proposed to enhance the spread of local anesthetic and improve analgesic coverage, particularly in the anterolateral chest wall and axillary regions commonly involved in mastectomy.
Tizanidine has been shown to reduce perioperative opioid and anesthetic requirements, stabilize hemodynamic responses to tracheal intubation, and minimize postoperative complications such as shivering and myocardial ischemia. Previous studies have demonstrated its effectiveness in reducing postoperative pain across a variety of surgical procedures, including laparoscopic cholecystectomy, thyroidectomy, anorectal surgery, hernia repair, and orthognathic surgery.Given the potential synergistic effects of combining regional anesthesia with systemic analgesics, this study aims to evaluate the efficacy of combining bilevel ESPB with a single oral dose of tizanidine for postoperative pain control in patients undergoing mastectomy.
Aim of the Study:
The aim of this study is to evaluate the effectiveness of combining bilevel erector spinae plane (ESP) block with a single preoperative oral dose of tizanidine in improving postoperative analgesia in patients undergoing mastectomy surgery.
Sample Size Calculation:
Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 3.1.9.2 for windows (2017). The primary outcome will be time to first analgesic request. In a pilot study performed on 10 patients using bilevel ESP block, the mean (SD) of time to first analgesic request was 21 (6.5) hours. Using a two-sided hypothesis test with a significance level of 0.05, assuming alpha = 0.05 and beta = 0.2 (power = 80%) and using a two-sided two-sample unequal-variance t-test, 39 subjects will be required in each group to detect 20 % difference between groups which is considered the minimal clinically important difference. To allow for subject dropouts, 45 subjects will be assigned to each group.
Methods; The study will be conducted in Mansoura oncology centre on 90 patients who will be scheduled for mastectomy surgery under general anesthesia. Informed written consent will be obtained from all subjects in the study after ensuring confidentiality. 90 eligible patients will be randomly assigned to 2 equal groups (Bilevel ESP block group) and (Bilevel ESP block+ tizanidine group) according to computer-generated table of random numbers using the permuted block randomization method. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes which will be opened only after obtaining the written informed consent.
The study protocol will be explained to all patients along with VAS after enrollment into the study. They will be kept fasting according to pre-operative ASA recommendations prior to surgery. Basic demographic characters including age, gender, and BMI will be recorded.
The peri-operative management will be identical in both groups. All patients with planned modified radical mastectomy will be assessed preoperatively by detailed medical history taking, clinical examination, Electrocardiography (ECG), and basal laboratory investigations as complete blood count (CBC), coagulation profile (PT, INR), blood glucose level, liver and renal function tests (liver enzymes, serum bilirubin, albumin and serum creatinine).
Statistical Methods:
The collected data will be coded, processed, and analyzed using SPSS program (version 22) for Windows. Normality of numerical data distribution will be tested by Shapiro-Wilk test. Continuous data of normal distribution will be presented as mean ± SD and will be compared with the unpaired student's t test. Non-normally distributed data will be presented as median (range) and will be compared with the Mann-Whitney U test. Categorical data will be presented as number (percentage) and will be compared with the Chi-square test. All data will be considered statistically significant if P value is ≤ 0.05.
- Conditions
- Mastectomy Patient
- Being tested
- Bilevel erector spinae plane block, Placebo Oral Capsule, tizanidine oral capsule
- Keywords
- Mastectomy, Analgesia, erector spinae plane block, tizanidine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilevel erector spinae plane blockProcedure or surgery
Also called ESP
Block will be performed unilaterally with the patient in the sitting position leaning forward. The block will be done using a high frequency linear probe (6-13 MHz). The block area will be adequately sterilized and draped, then the ultrasound probe will be placed 2-3 cm laterally from the midline at the level of the T3 spinous process using a sagittal approach to identify the hyperechoic transverse process shadow deep to the trapezius, rhomboid major, and erector spinae muscles. Then, the needle will be inserted craniocaudally in-plane to reach the transverse process deep to the erector spinae muscle. Correct positioning of the needle will be confirmed through real-time visualization of 2-mL saline hydro dissection. After confirmation of needle position, 15 mL of bupivacaine 0.25% will be injected at each level. The same procedure was repeated for the second level T5 spinous process. block failure defined as the presence of full sensation after 30 minutes, patients will be excluded .
Placebo Oral CapsuleDrug
Also called Placebo
One hour prior to anesthesia induction, the patients will recieve oral placebo capsule that will have the same color, smell, and size as tizanidine.
tizanidine oral capsuleDrug
Also called tizanidine
One hour prior to anesthesia induction, the tizanidine group will receive a 4 mg tizanidine oral capsule.
| Study group | Role | What they receive |
|---|---|---|
| Bilevel ESP block group | Active comparator | patients will have bilevel ESP block plus oral placebo capsule. Receives: Procedure: Bilevel erector spinae plane block; Drug: Placebo Oral Capsule |
| Bilevel ESP block + tizanidine group | Active comparator | patients will have bilevel ESP block plus oral tizanidine capsule. Receives: Procedure: Bilevel erector spinae plane block; Drug: tizanidine oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
First analgesic request
The time of the first analgesic request for fentanyl will be recorded.
Measured: Up to 24 hours after the procedure.
Secondary outcomes (5)
Visual analogue score (VAS) for pain assessment
VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed before the procedure, and then at 2, 4, 6, 12, and 24 h post operative.
Measured: Up to 24 hours after the procedure
Total analgesic requirements of fentanyl
The amount of fentanyl consumption given as a rescue analgesia to patients will be measured all over the 24 hours.
Measured: Up to 24 hours after the procedure
Heart rate (HR)
HR will be recorded before the procedure, after 15 min, 30 minutes and then every 30min intraoperative till the end of surgery.
Measured: Up to the end of the procedure
Mean arterial blood pressure (MAP)
MAP will be recorded before the procedure, after 15 min, 30 minutes and then every 30min intraoperative till the end of surgery.
Measured: Up to the end of the procedure
Adverse effects
respiratory depression, bradycardia, hypotension, nausea, vomiting, hematoma or allergic reactions will be recorded
Measured: Up to 24 hours after the procedure]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start15 Jul 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
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 Mastectomy PatientStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Prospective, randomized, double blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Hazem abdelmaksood EL-deeb, Mansoura University
- Investigators
- Amany H ELDeeb, MD, Principal investigator, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022353
- Sponsor's protocol ID
- ESP plus oral tizanidine
- Status last verified
- Jan 2026
- First submitted
- 8 Jun 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yazicioglu D, Caparlar C, Akkaya T, Mercan U, Kulacoglu H. Tizanidine for the management of acute postoperative pain after inguinal hernia repair: A placebo-controlled double-blind trial. Eur J Anaesthesiol. 2016 Mar;33(3):215-22. doi: 10.1097/EJA.0000000000000371.
PubMed 26555871Woodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641.
PubMed 28820803Mohammadi F, Marashi M, Tavakoli I, Khakbaz O. Effects of oral clonidine premedication on hemodynamic status in bimaxillary orthognathic surgery: A double-blind randomized clinical trial. J Craniomaxillofac Surg. 2016 Apr;44(4):436-9. doi: 10.1016/j.jcms.2016.01.004. Epub 2016 Jan 11.
PubMed 26874557Maniker RB, Damiano J, Ivie RMJ, Pavelic M, Woodworth GE. Perioperative Breast Analgesia: a Systematic Review of the Evidence for Perioperative Analgesic Medications. Curr Pain Headache Rep. 2022 Apr;26(4):299-321. doi: 10.1007/s11916-022-01031-z. Epub 2022 Feb 23.
PubMed 35195851Kurdi MS, Agrawal P, Thakkar P, Arora D, Barde SM, Eswaran K. Recent advancements in regional anaesthesia. Indian J Anaesth. 2023 Jan;67(1):63-70. doi: 10.4103/ija.ija_1021_22. Epub 2023 Jan 21.
PubMed 36970484Guan HY, Yuan Y, Gao K, Luo HX. Efficacy and safety of erector spinae plane block for postoperative analgesia in breast cancer surgery-A systematic review and meta-analysis. J Surg Oncol. 2023 May;127(6):905-920. doi: 10.1002/jso.27221. Epub 2023 Feb 24.
PubMed 36826370Forero 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 27501016Elsabeeny WY, Fahmy RM, Elshamy FH, Shehab NN, Abed SM, Taha WS, Ibrahim MA, Gad AF. Role of bilevel erector spinae with high thoracic block vs conventional unilevel block in analgesia and reduction of pain in axilla in breast cancer surgeries: a randomized controlled trial. Pain Rep. 2025 Jan 13;10(1):e1234. doi: 10.1097/PR9.0000000000001234. eCollection 2025 Feb.
PubMed 39816904Dadmehr S, Shooshtari Z, Alipour M, Eshghpour M, Shaban B, Vaezi T, Samieirad S. Is Preemptive Oral Tizanidine Effective on Postoperative Pain Intensity after Bimaxillary Orthognathic Surgery? A Triple-Blind Randomized Clinical Trial. World J Plast Surg. 2022 Jul;11(2):37-45. doi: 10.52547/wjps.11.2.37.
PubMed 36117905Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Bi-level erector spinae plane block for the control of severe back pain related to vertebral metastasis. BMJ Case Rep. 2019 Jun 20;12(6):e228129. doi: 10.1136/bcr-2018-228129.
PubMed 31227568Aksu C, Kus A, Yorukoglu HU, Tor Kilic C, Gurkan Y. Analgesic effect of the bi-level injection erector spinae plane block after breast surgery: A randomized controlled trial. Agri. 2019 Jul;31(3):132-137. doi: 10.14744/agri.2019.61687.
PubMed 31736025Ahiskalioglu A, Yayik AM, Oral Ahiskalioglu E, Dostbil A, Doymus O, Karadeniz E, Ari MA, Sengoz F, Alici HA, Celik EC. Ultrasound-guided bilateral superficial cervical block and preemptive single-dose oral tizanidine for post-thyroidectomy pain: a randomized-controlled double-blind study. J Anesth. 2018 Apr;32(2):219-226. doi: 10.1007/s00540-018-2468-x. Epub 2018 Feb 21.
PubMed 29468508
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Bi-level Erector Spinae Plane Block and Pre-emptive Single-dose Oral Tizanidine for Postoperative Analgesia After Mastectomy Surgery: a Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07022353
- Acronym / sponsor ID
- ESP plus oral tizanidine
- Conditions
- Mastectomy Patient
- Keywords
- Mastectomy, Analgesia, erector spinae plane block, tizanidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 15 Jun 2025 (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.
Effective management of postoperative pain in breast cancer surgery is essential to minimize the risk of developing postmastectomy pain syndrome.The aim of this study is to evaluate the effectiveness of combining bilevel erector spinae plane (ESP) block with a single preoperative oral dose of tizanidine in improving postoperative analgesia in patients undergoing mastectomy surgery.
It is hypothesized that the combination of bilevel ESP block and single-dose oral tizanidine will provide superior postoperative analgesia compared to bilevel ESP block alone in patients undergoing mastectomy.
Detailed description
Introduction:
Effective management of postoperative pain in breast cancer surgery is essential to minimize the risk of developing postmastectomy pain syndrome, a chronic condition that significantly impacts patients' quality of life. Multimodal analgesia, which combines pharmacological and non-pharmacological strategies, has been shown to enhance postoperative pain control and reduce opioid consumption. In recent years, regional anesthesia techniques have become increasingly favored for perioperative pain management in breast surgeries. The ESP block has gained popularity due to its simplicity, safety profile, and effectiveness in thoracic and breast surgeries. Its analgesic action is attributed to the craniocaudal spread of local anesthetic into the costovertebral foramina and epidural space, resulting in blockade of both ventral and dorsal rami of the spinal nerves and providing unilateral thoracic analgesia.The bilevel ESP block, which involves administering the block at two distinct thoracic levels, has been proposed to enhance the spread of local anesthetic and improve analgesic coverage, particularly in the anterolateral chest wall and axillary regions commonly involved in mastectomy.
Tizanidine has been shown to reduce perioperative opioid and anesthetic requirements, stabilize hemodynamic responses to tracheal intubation, and minimize postoperative complications such as shivering and myocardial ischemia. Previous studies have demonstrated its effectiveness in reducing postoperative pain across a variety of surgical procedures, including laparoscopic cholecystectomy, thyroidectomy, anorectal surgery, hernia repair, and orthognathic surgery.Given the potential synergistic effects of combining regional anesthesia with systemic analgesics, this study aims to evaluate the efficacy of combining bilevel ESPB with a single oral dose of tizanidine for postoperative pain control in patients undergoing mastectomy.
Aim of the Study:
The aim of this study is to evaluate the effectiveness of combining bilevel erector spinae plane (ESP) block with a single preoperative oral dose of tizanidine in improving postoperative analgesia in patients undergoing mastectomy surgery.
Sample Size Calculation:
Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 3.1.9.2 for windows (2017). The primary outcome will be time to first analgesic request. In a pilot study performed on 10 patients using bilevel ESP block, the mean (SD) of time to first analgesic request was 21 (6.5) hours. Using a two-sided hypothesis test with a significance level of 0.05, assuming alpha = 0.05 and beta = 0.2 (power = 80%) and using a two-sided two-sample unequal-variance t-test, 39 subjects will be required in each group to detect 20 % difference between groups which is considered the minimal clinically important difference. To allow for subject dropouts, 45 subjects will be assigned to each group.
Methods; The study will be conducted in Mansoura oncology centre on 90 patients who will be scheduled for mastectomy surgery under general anesthesia. Informed written consent will be obtained from all subjects in the study after ensuring confidentiality. 90 eligible patients will be randomly assigned to 2 equal groups (Bilevel ESP block group) and (Bilevel ESP block+ tizanidine group) according to computer-generated table of random numbers using the permuted block randomization method. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes which will be opened only after obtaining the written informed consent.
The study protocol will be explained to all patients along with VAS after enrollment into the study. They will be kept fasting according to pre-operative ASA recommendations prior to surgery. Basic demographic characters including age, gender, and BMI will be recorded.
The peri-operative management will be identical in both groups. All patients with planned modified radical mastectomy will be assessed preoperatively by detailed medical history taking, clinical examination, Electrocardiography (ECG), and basal laboratory investigations as complete blood count (CBC), coagulation profile (PT, INR), blood glucose level, liver and renal function tests (liver enzymes, serum bilirubin, albumin and serum creatinine).
Statistical Methods:
The collected data will be coded, processed, and analyzed using SPSS program (version 22) for Windows. Normality of numerical data distribution will be tested by Shapiro-Wilk test. Continuous data of normal distribution will be presented as mean ± SD and will be compared with the unpaired student's t test. Non-normally distributed data will be presented as median (range) and will be compared with the Mann-Whitney U test. Categorical data will be presented as number (percentage) and will be compared with the Chi-square test. All data will be considered statistically significant if P value is ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double blind study
| Arm | Type | Receives |
|---|---|---|
| Bilevel ESP block group | Active comparator | Procedure: Bilevel erector spinae plane block, Drug: Placebo Oral Capsulepatients will have bilevel ESP block plus oral placebo capsule. |
| Bilevel ESP block + tizanidine group | Active comparator | Procedure: Bilevel erector spinae plane block, Drug: tizanidine oral capsulepatients will have bilevel ESP block plus oral tizanidine capsule. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiology (ASA) ІІ patients.
- Scheduled for unilateral modified radical mastectomy.
- BMI levels between 18.5- 35 Kg/m2.
Key exclusion criteria (8 listed)
- Patient's refusal.
- Altered mental status or un-cooperative patients.
- History of known sensitivity to the used anesthetics.
- Bleeding or coagulation diathesis.
- Infection or redness at the injection site.
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 |
|---|---|---|
| Bilevel erector spinae plane blockAlso: ESPBlock will be performed unilaterally with the patient in the sitting position leaning forward. The block will be done using a high frequency linear probe (6-13 MHz). The block area will be adequately sterilized and draped, then the ultrasound probe will be placed 2-3 cm laterally from the midline at the level of the T3 spinous process using a sagittal approach to identify the hyperechoic transverse process shadow deep to the trapezius, rhomboid major, and erector spinae muscles. Then, the needle will be inserted craniocaudally in-plane to reach the transverse process deep to the erector spinae muscle. Correct positioning of the needle will be confirmed through real-time visualization of 2-mL saline hydro dissection. After confirmation of needle position, 15 mL of bupivacaine 0.25% will be injected at each level. The same procedure was repeated for the second level T5 spinous process. block failure defined as the presence of full sensation after 30 minutes, patients will be excluded . | Procedure or surgery | Bilevel ESP block + tizanidine group, Bilevel ESP block group |
| Placebo Oral CapsuleAlso: PlaceboOne hour prior to anesthesia induction, the patients will recieve oral placebo capsule that will have the same color, smell, and size as tizanidine. | Drug | Bilevel ESP block group |
| tizanidine oral capsuleAlso: tizanidineOne hour prior to anesthesia induction, the tizanidine group will receive a 4 mg tizanidine oral capsule. | Drug | Bilevel ESP block + tizanidine group |
Primary outcome
First analgesic request
Time frame: Up to 24 hours after the procedure.
The time of the first analgesic request for fentanyl will be recorded.
5 secondary outcomes
Visual analogue score (VAS) for pain assessment
Time frame: Up to 24 hours after the procedure
Total analgesic requirements of fentanyl
Time frame: Up to 24 hours after the procedure
Heart rate (HR)
Time frame: Up to the end of the procedure
Mean arterial blood pressure (MAP)
Time frame: Up to the end of the procedure
Adverse effects
Time frame: Up to 24 hours after the procedure]
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 27 Jan 2026.
- Background: PubMed 26555871Yazicioglu D, Caparlar C, Akkaya T, Mercan U, Kulacoglu H. Tizanidine for the management of acute postoperative pain after inguinal hernia repair: A placebo-controlled double-blind trial. Eur J Anaesthesiol. 2016 Mar;33(3):215-22. doi: 10.1097/EJA.0000000000000371.
- Background: PubMed 28820803Woodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641.
- Background: PubMed 26874557Mohammadi F, Marashi M, Tavakoli I, Khakbaz O. Effects of oral clonidine premedication on hemodynamic status in bimaxillary orthognathic surgery: A double-blind randomized clinical trial. J Craniomaxillofac Surg. 2016 Apr;44(4):436-9. doi: 10.1016/j.jcms.2016.01.004. Epub 2016 Jan 11.
- Background: PubMed 35195851Maniker RB, Damiano J, Ivie RMJ, Pavelic M, Woodworth GE. Perioperative Breast Analgesia: a Systematic Review of the Evidence for Perioperative Analgesic Medications. Curr Pain Headache Rep. 2022 Apr;26(4):299-321. doi: 10.1007/s11916-022-01031-z. Epub 2022 Feb 23.
- Background: PubMed 36970484Kurdi MS, Agrawal P, Thakkar P, Arora D, Barde SM, Eswaran K. Recent advancements in regional anaesthesia. Indian J Anaesth. 2023 Jan;67(1):63-70. doi: 10.4103/ija.ija_1021_22. Epub 2023 Jan 21.
- Background: PubMed 36826370Guan HY, Yuan Y, Gao K, Luo HX. Efficacy and safety of erector spinae plane block for postoperative analgesia in breast cancer surgery-A systematic review and meta-analysis. J Surg Oncol. 2023 May;127(6):905-920. doi: 10.1002/jso.27221. Epub 2023 Feb 24.
- 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 39816904Elsabeeny WY, Fahmy RM, Elshamy FH, Shehab NN, Abed SM, Taha WS, Ibrahim MA, Gad AF. Role of bilevel erector spinae with high thoracic block vs conventional unilevel block in analgesia and reduction of pain in axilla in breast cancer surgeries: a randomized controlled trial. Pain Rep. 2025 Jan 13;10(1):e1234. doi: 10.1097/PR9.0000000000001234. eCollection 2025 Feb.
- Background: PubMed 36117905Dadmehr S, Shooshtari Z, Alipour M, Eshghpour M, Shaban B, Vaezi T, Samieirad S. Is Preemptive Oral Tizanidine Effective on Postoperative Pain Intensity after Bimaxillary Orthognathic Surgery? A Triple-Blind Randomized Clinical Trial. World J Plast Surg. 2022 Jul;11(2):37-45. doi: 10.52547/wjps.11.2.37.
- Background: PubMed 31227568Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Bi-level erector spinae plane block for the control of severe back pain related to vertebral metastasis. BMJ Case Rep. 2019 Jun 20;12(6):e228129. doi: 10.1136/bcr-2018-228129.
- Background: PubMed 31736025Aksu C, Kus A, Yorukoglu HU, Tor Kilic C, Gurkan Y. Analgesic effect of the bi-level injection erector spinae plane block after breast surgery: A randomized controlled trial. Agri. 2019 Jul;31(3):132-137. doi: 10.14744/agri.2019.61687.
- Background: PubMed 29468508Ahiskalioglu A, Yayik AM, Oral Ahiskalioglu E, Dostbil A, Doymus O, Karadeniz E, Ari MA, Sengoz F, Alici HA, Celik EC. Ultrasound-guided bilateral superficial cervical block and preemptive single-dose oral tizanidine for post-thyroidectomy pain: a randomized-controlled double-blind study. J Anesth. 2018 Apr;32(2):219-226. doi: 10.1007/s00540-018-2468-x. Epub 2018 Feb 21.
- Individual participant dataSharing planned: No
Related trials for Mastectomy Patient
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer
Recruiting
Comparison of Mastectomy Expander Trial
Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction
Active, not recruitingObservational study
Autologous Nerve Graft Breast Reconstruction Neurotization
Breast Reconstruction, Breast Cancer Patients
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.
Amany H ELDeeb, MD principal investigator
Faculty of Medicine, Mansoura 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 Bilevel erector spinae plane block and tizanidine oral capsule in people with Mastectomy Patient, run by Mansoura 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 3 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 27 Jan 2026. 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?
First analgesic request (time frame: Up to 24 hours after the procedure.). 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 NCT07022353, 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 27 Jan 2026.