Health TrialsbyHealthPanel

Analgesic Efficacy of SPSIP Block Versus Paravertebral Block Following Thoracotomy

ConditionPost-thoracotomy Pain
Trial statusCompleted
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBursa City Hospital

About this trial

Thoracotomy causes severe postoperative pain that may impair respiratory function and increase complications. This study compares the postoperative analgesic effectiveness of the serratus posterior superior intercostal plane (SPSIP) block and the paravertebral block in patients undergoing thoracotomy. The aim is to determine whether the newly described serratus posterior superior intercostal plane block can serve as a safe and effective alternative to established techniques.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled to undergo thoracotomy

ASA physical status I-III according to the American Society of Anesthesiologists classification

Able to understand the study procedures and provide written informed consent

Disqualifiers

Declines or is unable to provide informed consent

Allergy or hypersensitivity to local anesthetics or opioids

Known or suspected coagulopathy

Infection at the injection site

Trial design

Design model

Parallel

Treatments tested in this trial

  • Serratus Posterior Superior Intercostal Plane Block

    Procedure/Surgery

    Ultrasound-guided regional anesthesia technique performed between the serratus posterior superior muscle and intercostal muscles.

  • Thoracic Paravertebral Block

    Procedure/Surgery

    Ultrasound-guided injection of local anesthetic into the thoracic paravertebral space to provide unilateral analgesia.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group SPSIPActive comparator 1 intervention
Group B: Group ParavertebralActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative 24-Hour PCA Opioid Consumption

Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 24 hours after surgery, recorded in milligrams (mg).

Time frame
Postoperative 24 hours

Secondary outcomes

1

NRS Pain Scores at Rest and Movement

Numeric Rating Scale (NRS) (0-10) pain scores at rest and during movement or coughing at predefined postoperative hours.

Time frame
2, 4, 8, 16, 24, and 48 hours postoperatively
2

QoR-15 Recovery Score

The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionairre PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]) Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time \[excellent\] and 0 = all of the time \[poor\]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed

Time frame
The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.]
3

Chronic Pain Assessment

Pain status using the Brief Pain Inventory (BPI) via telephone follow-up. General Scoring: The BPI comprises the Pain Severity and Pain Interference subscales. Each item is scored on a 0 (None/No interference) to 10 (Worst imaginable/Completely disabling) numerical scale. Higher scores indicate a worse clinical outcome. Subscale scores are calculated by taking the arithmetic mean of relevant items. 1. Pain Severity Subscale (4 Items): Assesses pain intensity over the last 24 hours. (0-10) What is your pain level right now What was your pain at its least in the last 24 hours What was your pain at its worst in the last 24 hours What was your pain on average in the last 24 hours 2. Pain Interference Subscale (7 Items): Assesses the degree to which pain interferes with daily functioning Questions: The patient rates how much pain interfered with: (0-10) General activity Mood Walking ability Normal work Relations with people Sleep Enjoyment of life

Time frame
3 months postoperatively
4

Rescue Analgesic Requirement

Number of patients requiring rescue analgesia (IV meperidine 0.5 mg/kg) and total dose administered when NRS ≥ 4.

Time frame
Postoperative 0-48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bursa City Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: