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Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year. Although it has a favorable prognosis with improved lines of treatment, some complications may still disturb the patient's life quality. One of these complications is post-mastectomy pain syndrome (PMPS) .Regional Anaesthesia (RA) is considered one of the most effective methods in reducing acute pain after breast surgeries, these include pectoral nerves block (PECS), serratus anterior plane block (SAPB), paravertebral plane block (PVPB) and erector spinae plane block (ESPB) . Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of PMPS in patients undergoing unilateral breast surgeries.
Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year. Although it has a favorable prognosis with improved lines of treatment, some complications may still disturb the patient's life quality. One of these complications is post-mastectomy pain syndrome (PMPS) ¹.
The International Association for Study of Pain (IASP) defines PMPS as chronic pain that persists more than 3 months in the anterior thorax, axilla &/or upper arm ². It is usually neuropathic in nature includes altered sensations such as dysesthesia, hypo or hyperesthesia, allodynia or particular qualities of dysesthesia e.g burning, dull aching sensations. It is usually of at least moderate intensity and may be either continuous or intermittent pain ³.
The etiology and mechanism of PMPS remain incompletely clear yet. Some risk factors are believed to be associated with PMPS, including the presence and intensity of postoperative pain, the type of surgery, younger women, prior history of other types of pain and adjuvant therapies like chemo or radiotherapy ⁴.
Regional Anaesthesia (RA) is considered one of the most effective methods in reducing acute pain after breast surgeries, these include pectoral nerves block (PECS), serratus anterior plane block (SAPB), paravertebral plane block (PVPB) and erector spinae plane block (ESPB) ⁵. Theoretically RA can minimize the development of PMPS by decreasing the afferent nociceptive input and central sensitization during the perioperative period, However clinically the role of RA in preventing PMPS is still under investigations ⁶.
PVPB includes injecting local anesthetic in the paravertebral space where the spinal nerves exit from the intervertebral foraminae. Paravertebral space is bounded by the parietal pleura, superior costotransverse ligament, vertebrae, intervertebral foraminae and the heads of the ribs ⁷. While ESPB includes injection of the local anesthetic in the fascial plane between the vertebral transverse processes and the erector spinae muscle ⁸.
Many studies were done in order to evaluate the efficacy of either ESPB or PVB in controlling acute postoperative pain after breast surgeries, some studies compared between them in controlling acute postoperative pain after breast surgeries ⁹. Also there are some studies that evaluate the effect of either ESPB or PVPB in the prevention of PMPS after breast surgeries ¹⁰, but still the comparison between the effect of preoperative ESPB versus the effect of preoperative PVPB in the prevention of PMPS in patients undergoing breast surgeries is still under investigated.
Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of PMPS in patients undergoing unilateral breast surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paravertebral Block Group | Active Comparator | This group will receive combined general anaesthesia with preoperative ultrasound guide paravertebral plane block |
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| Erector Spinae Block Group | Active Comparator | This group will receive combined general anaesthesia with preoperative ultrasound guided erector spinae plane block |
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| Control Group | Other | This group will receive balanced general anesthesia using intravenous (0.1mg/kg) morphine, 30 mg ketorlac and 1 gm paracetamol). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paravertebral plane block | Procedure | With the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the transverse processes clearly visualized . Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique toward the paravertebral space, immediately above the pleura and below the superior costotransverse ligament. The position of the needle is confirmed by the descent of the pleura when injecting 2 to 3 ml of saline solution for hydrolocalization. Then 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is to assess the incidence of PMPS 3 months after surgery. |
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| • The prevalence of PMPS at 6 months. | • The prevalence of PMPS at 6 months. | 6 months |
| • Assessment of acute postoperative pain. | • Assessment of acute postoperative pain using VAS (0 for no pain, 10 for the worst pain) at 0, 4, 8, 24 and 48 hours postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
Female patients ASA ΙΙ, ΙΙΙ between 18 and 60 years undergoing unilateral breast surgeries.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suzan Ahmed, MSc | Contact | 00201004610287 | suzansayed@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Suzan Ahmed, MS degree | National Cancer Institute, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCIEGYPT | Cairo | 11796 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33414157 | Background | Harkouk H, Fletcher D, Martinez V. Paravertebral block for the prevention of chronic postsurgical pain after breast cancer surgery. Reg Anesth Pain Med. 2021 Mar;46(3):251-257. doi: 10.1136/rapm-2020-102040. Epub 2021 Jan 7. | |
| 34926777 | Background | Yuksel SS, Chappell AG, Jackson BT, Wescott AB, Ellis MF. "Post Mastectomy Pain Syndrome: A Systematic Review of Prevention Modalities". JPRAS Open. 2021 Oct 30;31:32-49. doi: 10.1016/j.jpra.2021.10.009. eCollection 2022 Mar. |
| Label | URL |
|---|---|
| Comparative study between ultrasound guided erector spinae plane block versus paravertebral block for postoperative pain relief in patients undergoing unilateral modified radical mastectomy.AIMJ.2022. | View source |
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Study protocol will be shared
20 years
Clinical trials.gov
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| Erector spinae plane block | Procedure | With the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the tips of the transverse processes clearly visualized . The following muscles seen from superficial to deep layer are trapezius, rhomboid major and erector spinae muscles. Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique to reach the interfascial plane between the transverse process and the erector spinae muscle. Following confirmation of the accurate position of the needle tip with 3-5 ml normal saline solution, 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection. |
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| Intravenous morphine, ketorlac and paracetamol | Drug | • In the control group only we add 10mg intravenous morphine, 30 mg intravenous ketorlac and 1 gm intravenous paracetamol for analgesia. |
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| 48 hours |
| • Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption. | • Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption. | 48 hours . |
| • PVPB and ESPB related complications. | • PVPB and ESPB related complications (bupivacaine toxicity, pneumothorax). | 24 hours |
| 27668333 | Background | Waltho D, Rockwell G. Post-breast surgery pain syndrome: establishing a consensus for the definition of post-mastectomy pain syndrome to provide a standardized clinical and research approach - a review of the literature and discussion. Can J Surg. 2016 Sep;59(5):342-50. doi: 10.1503/cjs.000716. |
| 32443289 | Background | Gong Y, Tan Q, Qin Q, Wei C. Prevalence of postmastectomy pain syndrome and associated risk factors: A large single-institution cohort study. Medicine (Baltimore). 2020 May;99(20):e19834. doi: 10.1097/MD.0000000000019834. |
| 34826113 | Background | Xin L, Hou N, Zhang Z, Feng Y. The Effect of Preoperative Ultrasound-Guided Erector Spinae Plane Block on Chronic Postsurgical Pain After Breast Cancer Surgery: A Propensity Score-Matched Cohort Study. Pain Ther. 2022 Mar;11(1):93-106. doi: 10.1007/s40122-021-00339-9. Epub 2021 Nov 26. |
| 33560352 | Background | Zinboonyahgoon N, Patton ME, Chen YK, Edwards RR, Schreiber KL. Persistent Post-Mastectomy Pain: The Impact of Regional Anesthesia Among Patients with High vs Low Baseline Catastrophizing. Pain Med. 2021 Aug 6;22(8):1767-1775. doi: 10.1093/pm/pnab039. |
| 21804697 | Background | Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available. |
| 33340344 | Background | Bonvicini D, Boscolo-Berto R, De Cassai A, Negrello M, Macchi V, Tiberio I, Boscolo A, De Caro R, Porzionato A. Anatomical basis of erector spinae plane block: a dissection and histotopographic pilot study. J Anesth. 2021 Feb;35(1):102-111. doi: 10.1007/s00540-020-02881-w. Epub 2020 Dec 19. |
| 31879425 | Background | El Ghamry MR, Amer AF. Role of erector spinae plane block versus paravertebral block in pain control after modified radical mastectomy. A prospective randomised trial. Indian J Anaesth. 2019 Dec;63(12):1008-1014. doi: 10.4103/ija.IJA_310_19. Epub 2019 Dec 11. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000700 | Analgesics |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
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