Chronic Postoperative Pain Clinical Trial
Official title:
A Comparative Study Between the Effectiveness of Preoperative Erector Spinae Plane Block Versus Preoperative Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome. A Randomized Controlled Study.
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.
Status | Recruiting |
Enrollment | 51 |
Est. completion date | December 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Age = 18 years and = 60 years old. - Female patients ASA ??, ???. - Female patients scheduled for unilateral breast surgeries. Exclusion Criteria: - Patient refusal. - Patients have sepsis - Patients known to have allergy against local anesthetics. - Patients with prior surgery in areas above or below the clavicle or in the axillary region. - Patients with opioid dependence, alcohol or drug abuse. - Patient with coagulopathy. - Patients with psychiatric illness that prevent them from proper pain perception and assessment. - ASA 4 or higher. |
Country | Name | City | State |
---|---|---|---|
Egypt | NCIEGYPT | Cairo |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute, Egypt |
Egypt,
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: Pain Med. 2022 Jan 3;23(1):225. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome is to assess the incidence of PMPS 3 months after surgery. | A junior pain physician is blinded to all treatment groups and asks about symptoms of PMPS including (pain, tingling, numbness, shooting pain, pricking pain or unbearable itching), site (chest wall, armpit, arm, shoulder or surgical scar) and grading scale using the brief pain inventory (BPI).
Chronic pain is defined by a score of = 3 on the single item (average pain) of the BPI. The BPI consists of three domains: (1) Pain intensity measured using the visual analogue scale (VAS) of 0 (no pain) to 10 (worst pain). (2) Pain that interferes with daily activities measured using a scale of 0 (no interference) to 10 (complete restriction to daily activities). (3) Percentage of relief provided by pain treatments measured using a scale of 0 (complete relief) to 10 (no relief) by the NRS. |
3 months | |
Secondary | • The prevalence of PMPS at 6 months. | • The prevalence of PMPS at 6 months. | 6 months | |
Secondary | • 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. | 48 hours | |
Secondary | • 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 . | |
Secondary | • PVPB and ESPB related complications. | • PVPB and ESPB related complications (bupivacaine toxicity, pneumothorax). | 24 hours |
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