Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
Conditions
Keywords
Breast Augmentation Surgery, Breast Surgery, Multimodal Analgesia, Regional Anesthesia, PECS II Block Pectoral Nerve Block Ultrasound-Guided, Postoperative Pain, Postoperative Analgesia
Brief summary
This randomized, controlled clinical study will evaluate the effect of an ultrasound-guided PECS II block on postoperative pain control in patients undergoing elective augmentation mammoplasty. A total of 50 adult female patients aged 18-65 years who meet the eligibility criteria and provide written informed consent are planned to be enrolled. Participants will be randomly assigned to two groups using a computer-generated randomization method. Participants in the PECS II group will receive an ultrasound-guided PECS II block after induction of general anesthesia and before surgical incision, in addition to standard postoperative multimodal analgesia. Participants in the control group will receive standard postoperative multimodal analgesia without a PECS II block or placebo procedure. The primary objective is to evaluate postoperative pain intensity using the visual analog scale (VAS) at 1, 6, 12, and 24 hours after surgery. Secondary outcomes will include analgesic consumption, additional analgesic requirements, postoperative nausea and vomiting, and potential complications associated with the block. Outcomes will be compared between the two groups to assess the effect of the PECS II block on postoperative pain control.
Detailed description
This is a prospective, randomized, controlled, parallel-group clinical study designed to evaluate the effect of an ultrasound-guided PECS II block on postoperative analgesia in patients undergoing elective augmentation mammoplasty. Eligible participants who provide written informed consent will be randomly assigned in a 1:1 ratio to two groups using a computer-generated randomization method. The randomization sequence will be generated by an independent researcher, and allocation concealment will be maintained using sealed envelopes. Participants in the PECS II block group will receive an ultrasound-guided PECS II block after induction of general anesthesia and before surgical incision. Bupivacaine will be administered under aseptic conditions at the concentration and volume specified in the study protocol. Participants in the control group will not receive a PECS II block or a placebo procedure. Both groups will receive standard general anesthesia and the same postoperative multimodal analgesia protocol, consisting of paracetamol, nonsteroidal anti-inflammatory drugs, and opioids as needed. Remifentanil infusion will be used intraoperatively, with dose titration according to clinical requirements. Participants, the surgeon, and the investigator responsible for postoperative outcome assessment will be blinded to group allocation. The anesthesiologist performing the PECS II block will be aware of the intervention assignment. Postoperative assessments will be performed by an investigator who is blinded to group allocation. Intraoperative and postoperative data will be collected on pain intensity, analgesic consumption, additional analgesic requirements, postoperative nausea and vomiting, and potential complications associated with the block. The collected data will be compared between the two groups using appropriate statistical methods. The study will be conducted following approval by the relevant ethics committee and in accordance with applicable ethical principles.
Interventions
PROCEDUREUltrasound-Guided PECS II Block
An ultrasound-guided PECS II block will be performed after induction of general anesthesia and before surgical incision. Bupivacaine will be administered under aseptic conditions at the concentration and volume specified in the study protocol.
Standard multimodal analgesia will be administered according to the study protocol. The regimen will include the specified analgesic medications, with additional rescue analgesia administered when clinically indicated.
Sponsors
Ergun Gunduz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants, the surgeon, and the investigator responsible for postoperative outcome assessment will be blinded to group allocation. The anesthesiologist performing the PECS II block will not be blinded to the intervention assignment.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to two parallel groups using a computer-generated randomization method. The PECS II group will receive an ultrasound-guided PECS II block in addition to standard multimodal analgesia, whereas the control group will receive standard multimodal analgesia alone. Postoperative outcomes will be compared between the two groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18 to 65 years. * Patients scheduled for elective breast augmentation surgery. * Body weight of 40 kg or greater. * American Society of Anesthesiologists (ASA) physical status I or II. * Ability and willingness to provide written informed consent to participate in the study.
Exclusion criteria
* Refusal to participate in the study. * Serious cardiac disease. * Previous breast surgery. * History of chronic pain. * Neuromuscular disease. * Cognitive impairment or active psychiatric illness that may interfere with study -participation or outcome assessment. * Infection at the surgical or block injection site. * Coagulation disorder. * Known allergy or hypersensitivity to local anesthetic agents, including bupivacaine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity Measured by Visual Analog Scale (VAS) | 1, 6, 12, and 24 hours after surgery | Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at 1, 6, 12, and 24 hours after surgery. VAS scores will be compared between the PECS II block group and the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity Measured by Visual Analog Scale (VAS) | 1, 6, 12, and 24 hours after surgery | Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at 1, 6, 12, and 24 hours after surgery. VAS scores will be compared between the PECS II block group and the control group. |
Contacts
CONTACTErgun Gunduz, MD
PRINCIPAL_INVESTIGATORErgun Gunduz, MD
Istanbul Atlas University Faculty of Medicine Hospital
Outcome results
None listed