- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07700823
Two-Point Versus Single-Point Serratus Anterior Plane Block for Post-Thoracoscopic Surgery Analgesia
Comparison of Ultrasound-Guided Two-Point Combined vs Single-Point Serratus Anterior Plane Block for Postoperative Analgesia in Thoracoscopic Surgery: A Prospective Observational Cohort Study
Postoperative pain remains a common clinical challenge in patients undergoing video-assisted thoracoscopic surgery (VATS), impairing early recovery and increasing opioid consumption. The serratus anterior plane block (SAPB) is a widely used regional analgesic technique for thoracic surgery, but conventional single-point injection may have limited spread of local anesthetics, resulting in suboptimal analgesia in some patients. Preliminary anatomical evidence suggests that two-point combined SAPB may achieve wider dermatomal coverage and better analgesic efficacy.
This is a single-center, prospective observational cohort study conducted at Shanghai Pulmonary Hospital, China. A total of 88 adult patients scheduled for elective unilateral VATS will be consecutively enrolled and naturally assigned to either the two-point combined SAPB group (injection at the 3rd and 5th rib levels, total 30 ml local anesthetic) or the single-point SAPB group (injection at the 5th rib level, 30 ml local anesthetic) according to routine clinical practice.
The primary outcome is the verbal rating scale (VRS) pain score on coughing at 24 hours postoperatively. Secondary outcomes include resting and dynamic pain scores at multiple time points, cumulative opioid consumption at 24 and 48 hours, incidence of postoperative nausea and vomiting, block-related complications, length of hospital stay, and Quality of Recovery-15 (QoR-15) scores. This study aims to provide clinical evidence for optimizing perioperative analgesic strategies for thoracoscopic surgery.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Study Background Video-assisted thoracoscopic surgery (VATS) is the standard minimally invasive approach for thoracic diseases, yet over 60% of patients experience moderate-to-severe postoperative pain within 24 hours, which impairs respiratory function, increases opioid consumption and prolongs hospital stay. The serratus anterior plane block (SAPB) is a widely used fascial plane block for thoracic analgesia, but conventional single-point injection often yields inconsistent anesthetic spread due to individual anatomical variations, resulting in suboptimal analgesia in some patients. Preliminary anatomical and clinical evidence suggests that two-point combined SAPB may achieve wider dermatomal coverage and superior analgesic efficacy, but confirmatory evidence in VATS patients remains limited.
Study Design & Population This is a single-center, prospective observational cohort study conducted at Shanghai Pulmonary Hospital, China. A total of 88 eligible patients aged 18-85 years with ASA physical status I-III, scheduled for elective unilateral VATS and planned for perioperative SAPB, will be consecutively enrolled. Patients will be naturally allocated to the two-point group or single-point group according to the clinical regimen chosen by the attending anesthesiologist, with no researcher-initiated randomization. Exclusion criteria include local infection at the puncture site, allergy to amide local anesthetics, chronic opioid use, severe coagulopathy, and cognitive impairment precluding pain assessment.
Interventions & Outcomes All blocks are performed under ultrasound guidance by anesthesiologists with ≥50 prior SAPB experiences. The two-point group receives 15 ml of local anesthetic at both the 3rd and 5th rib levels (total 30 ml); the single-point group receives 30 ml at the 5th rib level. Standardized general anesthesia and postoperative analgesia protocols are applied uniformly to all patients. The primary outcome is the verbal rating scale (VRS) pain score on coughing at 24 hours postoperatively. Secondary outcomes include resting and dynamic pain scores at multiple time points, cumulative opioid consumption at 24 and 48 hours, incidence of postoperative nausea and vomiting, block-related complications, length of hospital stay, and QoR-15 recovery quality scores.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Shiyou Wei
- Puhelinnumero: 15601680288
- Sähköposti: lovewishyou@tongji.edu.cn
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- Aged 18 to 85 years at enrollment, regardless of sex
- American Society of Anesthesiologists (ASA) physical status grade I to III
- Scheduled for elective unilateral video-assisted thoracoscopic surgery
- Planned to receive ultrasound-guided SAPB for routine perioperative analgesia
- Able to understand study procedures and provide written informed consent
Exclusion Criteria:
- Local infection or skin lesion at the block puncture site
- Known hypersensitivity or allergy to amide local anesthetics
- Preexisting sensory abnormality in the chest wall surgical area
- Chronic opioid use for > 3 months, history of chronic pain syndrome, or history of opioid abuse
- Severe coagulopathy (international normalized ratio > 1.5 or platelet count < 80 × 10⁹/L)
- Cognitive impairment or inability to cooperate with postoperative pain assessment
- Refusal to provide written informed consent
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
Two-Point SAPB Group
Patients in this cohort receive ultrasound-guided two-point combined serratus anterior plane block for perioperative analgesia as part of routine clinical practice.
A total of 30 mL local anesthetic is administered, with 15 mL injected deep to the serratus anterior muscle at the 3rd rib level and 15 mL at the 5th rib level.
|
Ultrasound-guided fascial plane block for perioperative thoracic analgesia.
Local anesthetic is deposited deep to the serratus anterior muscle at two separate rib levels, with equal volume split between the 3rd and 5th intercostal spaces.
Muut nimet:
|
|
Single-Point SAPB Group
Patients in this cohort receive ultrasound-guided single-point serratus anterior plane block for perioperative analgesia as part of routine clinical practice.
A total of 30 mL local anesthetic is injected deep to the serratus anterior muscle at the 5th rib level in a single administration.
|
Ultrasound-guided fascial plane block for perioperative thoracic analgesia.
A single bolus of local anesthetic is deposited deep to the serratus anterior muscle at the 5th intercostal level.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Verbal Rating Scale (VRS) Pain Score on Coughing at 24 Hours Postoperatively
Aikaikkuna: 24 hours after surgery
|
Dynamic pain intensity assessed using a 0-10 verbal rating scale (0 = no pain, 10 = worst imaginable pain) when the patient performs coughing.
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24 hours after surgery
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Resting Verbal Rating Scale (VRS) Pain Scores
Aikaikkuna: 1 hour, 6 hours, 12 hours, 24 hours, 48 hours after surgery
|
Resting pain measured using a 0-10 verbal rating scale at multiple postoperative time points.
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1 hour, 6 hours, 12 hours, 24 hours, 48 hours after surgery
|
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Cumulative Postoperative Opioid Consumption
Aikaikkuna: 24 hours and 48 hours after surgery
|
Total opioid consumption after surgery, converted to standard intravenous morphine equivalents.
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24 hours and 48 hours after surgery
|
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Incidence of Postoperative Nausea and Vomiting (PONV)
Aikaikkuna: Within 48 hours after surgery
|
Proportion of patients experiencing nausea and/or vomiting within 48 hours after surgery.
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Within 48 hours after surgery
|
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Incidence of Block-Related Adverse Events
Aikaikkuna: Within 48 hours after surgery
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Proportion of patients with block-related complications, including pneumothorax, local hematoma, and local anesthetic toxicity.
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Within 48 hours after surgery
|
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Quality of Recovery-15 (QoR-15) Score
Aikaikkuna: 24 hours and 48 hours after surgery
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Patient-reported postoperative recovery quality assessed by the 15-item Quality of Recovery scale (total score range 0-150; higher score indicates better recovery quality).
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24 hours and 48 hours after surgery
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Shiyou Wei, Tongji University Affiliated Shanghai Pulmonary Hospital
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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