Pectoral Nerve Block Versus Serratus Posterior Superior Intercostal Plane Block for Pain Control After Mastectomy (PECS-SPSIPB)
Comparison of the Effects of Pectoral Nerve Block and Serratus Posterior Superior Intercostal Plane Block on Acute and Persistent Postoperative Pain After Mastectomy: A Prospective, Double-Blind, Randomized Controlled Trial
This study compares two ultrasound-guided nerve block techniques for pain control after mastectomy for breast cancer: the pectoral nerve block (PECS II) and the serratus posterior superior intercostal plane (SPSIP) block. Both techniques involve injecting local anesthetic near nerves supplying the surgical area.
The study will include 78 adults aged 18 to 85 years undergoing elective mastectomy under general anesthesia. Participants will be randomly assigned to receive one of the two blocks before surgery. Both groups will receive postoperative pain treatment, including a patient-controlled device that delivers tramadol when needed.
The main aim is to compare postoperative opioid consumption. The study will also assess pain at rest and during movement, the need for additional pain medication, side effects, recovery quality, and persistent pain. Pain scores and tramadol consumption will be recorded at 0, 2, 4, 8, 16, and 24 hours after surgery. Recovery quality will be assessed at 24 hours, and persistent pain will be assessed by telephone at 3 months.
Studieöversikt
Status
Detaljerad beskrivning
This prospective, randomized study will be conducted at Bursa City Hospital in adults undergoing elective mastectomy for breast cancer. Participants will be assigned to an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block or a pectoral nerve block (PECS II) using a computer-generated randomization sequence.
Both blocks will be performed before induction of general anesthesia. The SPSIP group will receive 30 mL of 0.25% bupivacaine in the fascial plane between the serratus posterior superior and intercostal muscles at the third rib. The PECS II group will receive 10 mL of 0.25% bupivacaine between the pectoralis major and pectoralis minor muscles and 20 mL between the pectoralis minor and serratus anterior muscles.
General anesthesia and postoperative multimodal analgesia will be standardized. On arrival in the recovery room, participants will receive intravenous patient-controlled analgesia with tramadol at a concentration of 5 mg/mL, a bolus dose of 10 mg, a lockout interval of 20 minutes, and no basal infusion. Intravenous meperidine at 0.5 mg/kg will be administered as rescue analgesia when the Numeric Rating Scale (NRS) score is 4 or higher.
Postoperative pain and opioid consumption will be assessed by an anesthesiologist who is unaware of group allocation. The clinician performing the block will know the assigned technique and will not collect postoperative outcome data.
NRS scores at rest and during movement will be recorded at 0, 2, 4, 8, 16, and 24 hours after surgery. The scale ranges from 0 (no pain) to 10 (the worst pain imaginable). Tramadol consumption will be recorded at the same time points. Rescue analgesic requirements, time to first rescue analgesia, time to first postoperative mobilization, length of hospital stay, adverse effects, and block-related complications will also be recorded.
Quality of recovery will be assessed using the Quality of Recovery-15 questionnaire at 24 hours after surgery. Postoperative nausea and vomiting will be monitored during the first 24 hours. Persistent postoperative pain will be assessed at 3 months using the McGill Pain Questionnaire during a telephone interview conducted with prior participant consent.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Enes Batuhan Cansız, MD
- Telefonnummer: 05384600660
- E-post: enbatuca55@gmail.com
Studieorter
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Bursa
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Nilufer, Bursa, Turkiet (Türkiye), 16110
- Rekrytering
- Bursa City Hospital
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Kontakt:
- emre ulusoy
- Telefonnummer: 05379492799
- E-post: emreulusoy36@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age between 18 and 85 years.
- Scheduled for elective mastectomy for breast cancer under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Willingness to participate in the study and provide informed consent.
Exclusion Criteria:
- Refusal to participate in the study.
- History of bleeding diathesis or coagulopathy.
- Receiving anticoagulant therapy.
- Allergy or hypersensitivity to local anesthetics or opioid medications.
- History of local anesthetic toxicity.
- Infection at the planned block injection site.
- Hepatic or renal failure.
- Uncontrolled diabetes mellitus.
- Uncontrolled hypertension.
- Intellectual disability.
- Receiving opioid treatment for chronic pain.
- Pregnancy, suspected pregnancy, or breastfeeding.
- Planned bilateral mastectomy.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: Serratus Posterior Superior Intercostal Plane Block (SPSIP)
Participants will receive an ultrasound-guided SPSIP block on the surgical side before induction of general anesthesia. With the participant seated, 30 mL of 0.25% bupivacaine with epinephrine will be injected into the fascial plane between the serratus posterior superior and intercostal muscles at the third rib. Participants will also receive standardized general anesthesia and postoperative multimodal analgesia, including patient-controlled intravenous tramadol and rescue analgesia when required. |
A single ultrasound-guided block will be performed on the surgical side before induction of general anesthesia. With the participant seated and the hand on the opposite shoulder, a high-frequency linear ultrasound probe will be positioned along the medial scapular border to identify the third rib and serratus posterior superior muscle. A 50-mm block needle will be advanced in-plane in a caudal-to-cranial direction. After confirming the plane with 5 mL of saline, 30 mL of 0.25% bupivacaine with epinephrine will be injected between the serratus posterior superior and intercostal muscles.
Andra namn:
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Aktiv komparator: Pectoral Nerve Block (PECS II)
Participants will receive an ultrasound-guided PECS II block on the surgical side before induction of general anesthesia. With the participant supine, 10 mL of 0.25% bupivacaine with epinephrine will be injected between the pectoralis major and pectoralis minor muscles, followed by 20 mL between the pectoralis minor and serratus anterior muscles. Participants will also receive standardized general anesthesia and postoperative multimodal analgesia, including patient-controlled intravenous tramadol and rescue analgesia when required. |
A single ultrasound-guided PECS II block will be performed on the surgical side before induction of general anesthesia, with the participant supine. A high-frequency linear ultrasound probe will be used to identify the pectoralis major, pectoralis minor, and serratus anterior muscles. A 50-mm block needle will be advanced using an in-plane approach. After confirming each injection plane with 5 mL of saline, 10 mL of 0.25% bupivacaine with epinephrine will be injected between pectoralis major and pectoralis minor, followed by 20 mL of the same solution between pectoralis minor and serratus anterior.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative Opioid Consumption
Tidsram: First 24 hours postoperatively, with recordings at 0, 2, 4, 8, 16, and 24 hours.
|
Postoperative opioid consumption will be compared between the groups. Tramadol consumption administered through intravenous patient-controlled analgesia will be recorded in milligrams at 0, 2, 4, 8, 16, and 24 hours postoperatively. The total dose of rescue meperidine will be recorded separately. |
First 24 hours postoperatively, with recordings at 0, 2, 4, 8, 16, and 24 hours.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Intensity at Rest
Tidsram: At 0, 2, 4, 8, 16, and 24 hours postoperatively.
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Pain intensity at rest will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (the worst pain imaginable). Higher scores indicate greater pain intensity. |
At 0, 2, 4, 8, 16, and 24 hours postoperatively.
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Pain Intensity During Movement
Tidsram: At 0, 2, 4, 8, 16, and 24 hours postoperatively.
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Pain intensity during movement will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (the worst pain imaginable). Higher scores indicate greater pain intensity. |
At 0, 2, 4, 8, 16, and 24 hours postoperatively.
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Total Rescue Analgesic Dose
Tidsram: During the first 24 hours postoperatively.
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The total dose of intravenous meperidine administered as rescue analgesia will be recorded in milligrams. Meperidine at 0.5 mg/kg will be administered when the Numeric Rating Scale score is 4 or higher. |
During the first 24 hours postoperatively.
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Time to First Rescue Analgesia
Tidsram: During the first 24 hours postoperatively.
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The time of the first postoperative administration of rescue analgesia will be recorded. Intravenous meperidine at 0.5 mg/kg will be administered when the Numeric Rating Scale score is 4 or higher. |
During the first 24 hours postoperatively.
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Quality of Recovery-15 Score
Tidsram: At 24 hours postoperatively.
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Quality of postoperative recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire. The questionnaire contains 15 items, with a total score ranging from 0 to 150. Higher scores indicate better quality of recovery. |
At 24 hours postoperatively.
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Postoperative Nausea and Vomiting
Tidsram: During the first 24 hours postoperatively.
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Postoperative nausea and vomiting will be assessed using a four-category scale: 1 = no nausea or vomiting; 2 = nausea without vomiting; 3 = one episode of vomiting or persistent nausea; and 4 = two or more episodes of vomiting or severe/persistent retching. Higher scores indicate more severe symptoms. |
During the first 24 hours postoperatively.
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Persistent Postoperative Pain Assessed Using the McGill Pain Questionnaire
Tidsram: At 3 months postoperatively.
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Persistent postoperative pain will be assessed using the McGill Pain Questionnaire during a telephone interview at 3 months after surgery. Participants will provide prior consent for telephone follow-up. |
At 3 months postoperatively.
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BSH001
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