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SPSIPB Versus SAPB for Postoperative Analgesia After Minimally Invasive Repair of Pectus Excavatum

ConditionsPectus ExcavatumChest Deformities
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-25
SponsorMarmara University

About this trial

This prospective observational cohort study will compare postoperative analgesic outcomes in patients undergoing minimally invasive repair of pectus excavatum. Participants will be grouped according to the regional analgesia technique applied as part of routine clinical care: serratus posterior superior intercostal plane block or serratus anterior plane block. The primary outcome will be total opioid consumption during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores, rescue analgesic requirement, opioid-related adverse effects, patient satisfaction, mobilization time, and length of hospital stay.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 15 to 25 years

Diagnosis of pectus excavatum

Scheduled to undergo minimally invasive repair of pectus excavatum under general anesthesia

Receipt of either bilateral serratus posterior superior intercostal plane block or bilateral serratus anterior plane block as part of routine perioperative analgesic care

Disqualifiers

Refusal to participate in the study

Contraindication to regional anesthesia

Known allergy to local anesthetics or study analgesic medications

Chronic opioid use

Trial population

The study population will include patients aged 15 to 25 years who are diagnosed with pectus excavatum and scheduled to undergo minimally invasive repair of pectus excavatum under general anesthesia. Patients who receive either bilateral serratus posterior superior intercostal plane block or bilateral serratus anterior plane block as part of routine perioperative analgesic care will be included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Postoperative Analgesia Protocol

    Drug

    All participants will receive a standardized multimodal postoperative analgesia protocol. Patient-controlled analgesia with intravenous morphine will be used. The device will be programmed to administer 1 mg of intravenous morphine per demand, with a lockout interval of 10 minutes. Paracetamol will be administered as part of routine multimodal analgesia. If adequate analgesia cannot be achieved, 100 mg tramadol will be administered as rescue analgesia according to clinical need.

  • Bispectral Index Monitoring

    Device

    Continuous intraoperative depth of anesthesia monitoring using the Bispectral Index (BIS) device. BIS values are recorded throughout the procedure to assist in titration of anesthetic agents and to standardize anesthesia depth across study cohorts. The BIS device is used for monitoring only, and no device-related investigational procedures are performed.

  • Serratus Posterior Superior Intercostal Plane Block

    Procedure/Surgery

    Bilateral ultrasound-guided serratus posterior superior intercostal plane block will be performed according to standard techniques described in the literature and routinely used in the clinic. Local anesthetic dosing will be determined according to institutional practice and safety limits. In bilateral applications, the total bupivacaine dose will not exceed 2.5 mg/kg.

  • Serratus Anterior Plane Block

    Procedure/Surgery

    Bilateral ultrasound-guided serratus anterior plane block will be performed according to standard techniques described in the literature and routinely used in the clinic. Local anesthetic dosing will be determined according to institutional practice and safety limits. In bilateral applications, the total bupivacaine dose will not exceed 2.5 mg/kg.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Serratus Anterior Plane Block Group3 interventions
Group B: Serratus Posterior Superior Intercostal Plane Block Group3 interventions

Trial outcomes

Primary outcomes

1

Total postoperative opioid consumption during the first 24 hours

Total opioid consumption during the first 24 hours after surgery will be recorded and expressed as intravenous morphine equivalents in milligrams.

Time frame
From the end of surgery to 24 hours postoperatively

Secondary outcomes

1

Intraoperative opioid consumption

Total intraoperative opioid consumption will be recorded.

Time frame
From induction of anesthesia to the end of surgery
2

Postoperative pain scores

Pain intensity will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame
At arrival in the post-anesthesia care unit and at postoperative 6, 12, 24, and 48 hours
3

Patient satisfaction

Patient satisfaction with postoperative analgesia will be assessed using a 4-point Likert scale, where 0 indicates very dissatisfied and 3 indicates very satisfied.

Time frame
At postoperative 6, 12, 24, and 48 hours
4

Incidence of Opioid-Related Adverse Effects

Presence of nausea, vomiting, pruritus, constipation, urinary retention, sedation, and respiratory depression. Adverse effects will be compared among the two groups.

Time frame
From the end of surgery to 48 hours postoperatively

Other outcomes

Sponsors and contacts

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Marmara University

Lead sponsor

Source ClinicalTrials.gov
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