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Clinical Trials/NCT04222010
NCT04222010
Completed
Phase 3

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country155 target enrollmentJanuary 2, 2020

Overview

Phase
Phase 3
Intervention
loco-regional anesthesia serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL)
Conditions
Anesthesia, Local
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
155
Locations
1
Primary Endpoint
Pain Visual analog scale (VAS) score at coughing
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2020
End Date
February 22, 2023
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • rejection of consent
  • rejection of loco-regional anesthesia
  • chronic pain antecedents under morphine medication
  • pain assessment impossible

Arms & Interventions

serratus loco-regional anesthesia

patient who underwent thoracoscopic surgery will be assigned to serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL)

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

Outcomes

Primary Outcomes

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

  • Pain Visual analog scale (VAS) score at coughing(Day3 = 3 days following thoracoscopic surgery)

Study Sites (1)

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