Analgesia
Conditions
Keywords
Rhomboid Intercostal Block, Erector Spinae Plane Block, Reduction Mammoplasty, Analgesia
Brief summary
Bilateral reduction mammoplasty is one of the most commonly performed breast surgery. The Postoperative pain following it should be minimized. Opioid administration for acute pain after reduction mammoplasty surgery has many side effects. Regional block techniques such as paravertebral block and thoracic epidural anesthesia have possible complications and technical difficulties. The new alternative regional techniques such as erector spinae plane block and rhomboid intercostal plane block are clinical trials for providing a safe, easy, and painless anesthetic procedure with adequate postoperative analgesia for a large section of patients undergoing thoracic surgeries.
Detailed description
Reduction mammoplasty is the gold standard procedure for symptomatic breast hypertrophy and it is also used for contralateral breast symmetrisation following breast cancer surgery. Symptomatic hypermastia affects the quality of life of millions of women worldwide. The most frequent symptoms shown by more than two-thirds of patients are shoulder grooving, and back, shoulder, and neck pain. Reduction mammoplasty proved to be an effective treatment, both aesthetically and functionally, with a demonstrated consistently high patient satisfaction. Optimal pain management is an essential component of enhanced recovery after surgery protocols that are becoming standard of care because they have been shown to reduce postoperative complications and expedite recovery. However, postoperative pain is still inadequately managed. Opioids remain the mainstay of perioperative pain management, despite well-recognized adverse events including nausea, vomiting, pruritus, and respiratory depression. Regional anesthesia has been believed as one of the formats for effective perioperative pain control. Plane blocks such as the serratus anterior plane (SAP) block, pectoral nerve block, and erector spinae plane block have gained popularity during multimodal analgesia after various surgical procedures. The erector spinae plane block (ESPB) was initially introduced by Forero et al. in 2016 and offers extensive analgesia in thoracic surgery. It can be used as a substitute for PVB because it is less intrusive, simpler, and safer to apply plane blocks that are applied in the plane of the spine's erector muscles. Rhomboid intercostal block (RIB) was described in 2016 as an alternative to thoracic epidural analgesia. The local anesthetic agent is delivered into the plane between the rhomboid major and intercostal muscles. That provides good analgesia for the anterior and posterior hemithorax.
Interventions
PROCEDUREgeneral anesthesia
patients will receive general anesthesia.
PROCEDUREErector spinae plane block
patients will receive Erector spinae plane block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.
PROCEDUREa rhomboid intercostal nerve block
patients will receive a rhomboid intercostal nerve block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.
DRUGBupivacaine
20 ml of bupivacaine 0.25%
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double (Participant, Outcomes Assessor) double-blinded(participants and outcome assessors)
Intervention model description
computer generating random numbers, the patients will be allocated into three equal groups: Group C: (control group) patients will receive general anesthesia. Group E: patients will receive an Erector spinea plane block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia. Group R: patients will receive rhomboid intercostal nerve block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient acceptance. * Age 18-65 years old. * BMI ≤ 35 kg/m2 * ASA I - II. * Elective bilateral reduction mammoplasty surgery under general anesthesia. * Duration of surgery within five hours
Exclusion criteria
* Patients on anti-platelet, anticoagulant, or B blocker drugs. * Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma * History of allergy to the local anesthetics (LA) agents used in this study, * Skin lesion at the needle insertion site, * Those with bleeding disorders, sepsis, liver disease, psychiatric disorders, and pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first dose of rescue analgesia | in the first postoperative 24 hours | is the time from the end of operation to patient reporting VAS ≥ 3. Thereafter, rescue analgesia in the form of 0.1mg/kg IV of nalbuphine will be injected. |
| Total nalbuphine consumption | in the first 24 hours postoperatively | total dose of nalbuphine rescue analgesic that the patient required postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes of pain assessment | at 1hour, 3,6,12, 24 hours postoperatively | visual analogue scale will be recorded at rest and movement |
| non invasive blood pressure | immediately prior to surgery, immediately after skin incision, 15,30,60,120,180,240 min intraoperatively and at end of surgery | changes of hemodynamics |
Countries
Egypt
Outcome results
None listed