NCT07540104

Brief Summary

This study aims to compare the analgesic effects of the serratus posterior superior intercostal plane block and intrathecal morphine in patients undergoing video-assisted thoracoscopic surgery. This is a prospective, randomized, controlled, single-center clinical trial including adult patients undergoing elective thoracoscopic surgery. Participants will be randomly assigned to receive either a serratus posterior superior intercostal plane block or intrathecal morphine before general anesthesia. The primary outcome is cumulative opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine milligram equivalents. Secondary outcomes include pain scores, time to first analgesic request, quality of recovery, and postoperative complications. The study aims to determine whether these two techniques differ in their effectiveness for postoperative pain management.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

April 9, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 9, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

Thoracic Surgery, Video-AssistedAnalgesia, PostoperativeMorphineInjections, SpinalNerve Block

Outcome Measures

Primary Outcomes (1)

  • Cumulative opioid consumption within 24 hours after surgery

    Total opioid consumption during the first 24 postoperative hours is expressed as intravenous morphine milligram equivalents, including patient-controlled analgesia and rescue analgesia.

    24 hours

Secondary Outcomes (14)

  • Cumulative opioid consumption within 12 hours after surgery

    12 hours

  • Postoperative pain scores

    0, 3, 6, 12, 18, and 24 hours postoperatively

  • Time to first patient-controlled analgesia demand

    24 hours

  • Quality of recovery score

    Preoperative baseline, 24 hours postoperatively, and at discharge

  • Postoperative nausea and vomiting

    0, 3, 6, 12, 18, and 24 hours postoperatively

  • +9 more secondary outcomes

Other Outcomes (2)

  • Heart Rate

    Intraoperative period (up to 4 hours)

  • Mean Arterial Pressure

    Intraoperative period (up to 4 hours)

Study Arms (2)

Intrathecal Morphine

EXPERIMENTAL

Participants receive intrathecal morphine before induction of general anesthesia. Intrathecal morphine is administered at a dose of 5 micrograms per kilogram in 3 milliliters of saline via spinal injection. All patients subsequently undergo standardized general anesthesia and receive postoperative patient-controlled analgesia with intravenous morphine.

Procedure: Intrathecal Morphine

Serratus Posterior Superior Intercostal Plane Block

EXPERIMENTAL

Participants receive an ultrasound-guided serratus posterior superior intercostal plane block before induction of general anesthesia. A total of 30 milliliters of 0.25 percent bupivacaine with epinephrine is administered into the interfascial plane between the serratus posterior superior muscle and intercostal muscles. All patients subsequently undergo standardized general anesthesia and receive postoperative patient-controlled analgesia with intravenous morphine.

Procedure: Serratus Posterior Superior Intercostal Plane Block

Interventions

Intrathecal morphine is administered at a dose of 5 micrograms per kilogram diluted in 3 milliliters of saline via spinal injection at the lumbar level before induction of general anesthesia.

Intrathecal Morphine

Ultrasound-guided serratus posterior superior intercostal plane block is performed before induction of general anesthesia using 30 milliliters of 0.25 percent bupivacaine with epinephrine injected into the interfascial plane between the serratus posterior superior muscle and intercostal muscles.

Serratus Posterior Superior Intercostal Plane Block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 years
  • American Society of Anesthesiologists physical status I to III
  • Scheduled for elective video-assisted thoracoscopic surgery including wedge resection, segmentectomy, or lobectomy

You may not qualify if:

  • Refusal to participate
  • Pregnancy
  • Morbid obesity (body mass index greater than 40 kg per square meter)
  • Allergy to opioids, local anesthetics, or nonsteroidal anti-inflammatory drugs
  • Neuropsychiatric disorders, cognitive impairment, or inability to communicate
  • History of substance abuse
  • Use of anticoagulant therapy or presence of bleeding disorders
  • Active systemic infection
  • Severe cardiovascular, hepatic, renal, or endocrine disease
  • Chronic pain syndrome or ongoing chronic pain treatment
  • Emergency surgery or prior ipsilateral thoracic surgery
  • Preoperative opioid use
  • Significant intraoperative or postoperative bleeding or hemodynamic instability
  • Requirement for prolonged postoperative mechanical ventilation longer than 18 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Atakent, Samsun, 55270, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Central Study Contacts

Cengiz Kaya, Prof Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 20, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations