Clinical trial NCT03614091: Paravertebral Block Versus Erector Spinae Plane Block for Modified Radical Mastectomy in Womens.
Official title: Analgesic and Pulmonary Function Effects of Erector Spinae Plane Block Versus Paravertebral Plane Block for Women's Undergoing Modified Radical Mastectomy; Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Pulmonary Atelectasis
Mastectomy
Keywords: Paravertebral block
Erector spinae plane block
Modified radical mastectomy
respirometer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: postoperative pain following Modified radical mastectomy is severe specially after dissection of tissues .paravertebral plane block provides an excellent postoperative analgesia for women's,but it carry the risk of pneumothorax which it reported in some cases.Erector spinae plane block is a recent block has been mentioned in many case reports as a safe,quick and can be used in outpatient setting. we use a comparative study to compare the postoperative analgesia between both blocks and the affection of postoperative pain following both blocks if any on pulmonary functions.

Detailed description: Postoperative pain is one of the commonest problems encountered by anesthesiologists in their practice, especially after radical mastectomy surgeries , in which post-operative pain would cause a restrictive respiratory dysfunction, which is associated with poor postoperative outcomes.

Postoperative pulmonary complications (PPCs) are the leading cause of death and increase hospital care expenditures in cardiothoracic and non- cardiothoracic surgery. Included under the heading of (PPCs) are respiratory failure, pneumonia, atelectasis, and exacerbation of chronic obstructive pulmonary disease.

Modiﬁed radical mastectomy, usually performed for the treatment of breast cancer, is associated with considerable acute postoperative pain and restricted shoulder mobility An estimated 40% of women report significant pain symptoms following mastectomy Poor pain relief has been associated with additional healthcare costs, resource utilization and prolonged inpatient stay after surgery.

the thoracic paravertebral block (TPVB) is the most widely used technique to provide postoperative analgesia after breast surgeries Advantages of a TPVB technique include reduced postoperative pain, analgesic consumption and shorter post anesthesia care unit (PACU) stay There is also evidence to suggest that TPVB may have a favorable impact on cancer recurrence after mastectomy. Paravertebral blockade results in somatosensory and sympathetic blockade after injection of local anesthetic solution to the paravertebral space posterior to the pleura.

Erector spinae plane (ESP) block is a recently described technique which may be an alternative to PVB for providing thoracic analgesia. Numerous case reports and case series describe ESP block for the management of acute and chronic thoracic pain. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle.

Radiological imaging in a cadaver model has demonstrated that a single injection at the level of the T5 transverse process produced cranio-caudal spread between C7 and T8 . This accounts for the extensive sensory block that has been observed in case reports and is at least as extensive as the spread seen with TPVB ESP is a more superficial block with a better defined end-point - injection between the bony transverse process and erector spinae muscle. A more superficial ultrasound-guided block will be faster to perform and less painful for the patient. Furthermore, ESP does not have the same risk of pneumothorax as TPVB. There have been no randomized controlled trials involving ESP to date. All descriptions of the technique have been in case report / series format.

The investigators hypothesize that ESP block efficacy is not inferior to TPVB with reference to dermatomal sensory spread and analgesic efficacy, while being easier to perform, has less associated discomfort and fewer complication risk ESP has been no randomized in many case trials and they found that it effective as postoperative analgesia in modified radical mastectomy.

Eligibility criteria: Inclusion Criteria:

* ASA grade II-III.
* female patients in the age group of 18-50 yr.
* undergoing modiﬁed radical mastectomy under general anesthesia.
* BMI \<40 kg.m2.

Exclusion Criteria:

* pre-existing infection at the block site.
* Coagulopathy.
* morbid obesity (BMI \>40 kg m-2).
* allergy to local anesthetics.
* decreased pulmonary reserve.
* major cardiac disorders.
* renal dysfunction.
* pre-existing neurological deﬁcits.
* psychiatric illness.

Primary outcomes:
measure: Pulmonary Function Tests(PFT)
timeFrame: preoperative and 24 hours postoperative
Secondary outcomes:
measure: Opioid consumption
timeFrame: 24 hours postoperatively
measure: Hospital stay
timeFrame: 72 hours
measure: Dermatomal distribution
timeFrame: 30 minutes after block will be assessed every 5 minutes
measure: Incidence of Side effects and complication during study
timeFrame: 24 hours
measure: Time to first analgesic requirement
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assisstant professor in Anaesthesia and ICU department,faculty of medicine,Assiut University ,egypt
name: jehan ahmed sayed, MD
role: STUDY_DIRECTOR
affiliation: Professor of Anesthesia & ICU Faculty of Medicine - Assiut University,egypt
name: mahmoud abdel aziz ali, PHD
role: STUDY_CHAIR
affiliation: assisstant lecturer of Anaesthesia and ICU department,faculty of medicine ,Assiut University,egypt
name: mahmoud bahaa mousa, M.B.B.Ch
role: PRINCIPAL_INVESTIGATOR
References: