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Completed

NCT Number: NCT04222010

Serratus Plain Block Versus Paravertebral Block Versus Serratus Plain Block and Paravertebral Block for Postoperative Pain Following Thoracoscopic Surgery

Acute and chronic postoperative pain remains a major concern following thoracoscopic surgery. Firstly because pain constitutes a serious concern for patients after surgery, and secondarily because an ineffective control of pain may lead to postoperative morbidity, especially in lung cancer surgery.

To date, several procedures have been described but the best modality of locoregional analgesia for thoracoscopic surgery has not been assessed yet. The main objective of this study is to evaluate efficiency of several validated approaches for preoperative locoregional analgesia, comparing serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery.

To this end, the investigators will conduct an interventional prospective monocentric, double blind, compared and randomized study. Previously to thoracoscopic surgery, patients will be randomized in one of the three following arms: serratus plain block, paravertebral block or serratus plain block and paravertebral block combined.

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Key information

Conditions

Anesthesia, Local Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patient over18 years old
  • without guardianship
  • video-assisted thoracoscopic surgery with 3 trocars
  • No cons-indications to loco-regional anesthesia (allergy, skin condition)

Exclusion criteria

  • patient under 18 years old
  • patient under guardianship
  • pregnant
  • rejection of consent
  • rejection of loco-regional anesthesia
  • chronic pain antecedents under morphine medication
  • pain assessment impossible

Treatment and study plan

loco-regional anesthesia serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL)

Drug

Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia

Loco-regional anesthesia : paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL)

Drug

Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia.

Loco-regional anesthesia : serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL)

Drug

Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia.

Primary outcomes

  1. Pain Visual analog scale (VAS) score at coughing

    Time frame: Immediately after following thoracoscopic surgery

    Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.

    Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.

    With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).

Secondary outcomes

  1. Pain Visual analog scale (VAS) score at coughing

    Time frame: H1 = one hour following thoracoscopic surgery

    Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.

    Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.

    With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).

  2. Pain Visual analog scale (VAS) score at coughing

    Time frame: H3 = 3 hours following thoracoscopic surgery

    Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.

    Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.

    With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).

  3. Pain Visual analog scale (VAS) score at coughing

    Time frame: H6 = 6 hours following thoracoscopic surgery

    Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.

    Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.

    With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).

  4. Pain Visual analog scale (VAS) score at coughing

    Time frame: Day1 = one day following thoracoscopic surgery

    Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.

    Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.

    With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).

  5. Pain Visual analog scale (VAS) score at coughing

    Time frame: Day2 = two days following thoracoscopic surgery

    Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.

    Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.

    With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).

  6. Pain Visual analog scale (VAS) score at coughing

    Time frame: Day3 = 3 days following thoracoscopic surgery

    Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.

    Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.

    With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: thoracoscopic

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 9, 2020
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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