Clinical trial NCT06036979: Preoperative Erector Spinae Plane Block Versus Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome
Official title: A Comparative Study Between Preoperative Erector Spinae Plane Block Versus Preoperative Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome. A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Postoperative Pain
Keywords: PVPB, ESPB, prevention of PMPS
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years and ≤ 60 years old.
* Female patients ASA ΙΙ, ΙΙΙ.
* 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.

Primary outcomes:
measure: The primary outcome is to assess the incidence of PMPS 3 months after surgery.
timeFrame: 3 months
Secondary outcomes:
measure: • The prevalence of PMPS at 6 months.
timeFrame: 6 months
measure: • Assessment of acute postoperative pain.
timeFrame: 48 hours
measure: • Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption.
timeFrame: 48 hours .
measure: • PVPB and ESPB related complications.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NCIEGYPT
Study officials:
affiliation: National Cancer Institute, Egypt
name: Suzan Ahmed, MS degree
role: PRINCIPAL_INVESTIGATOR
References:
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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.
citation: Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.
citation: 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.
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.