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

Pain, Postoperative Clinical Trial

— thoracoscopic  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04222010
• Other study ID #: PI2019_843_0051
• Status: Completed
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: September 12, 2023

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: September 12, 2023
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Pain, Postoperative

Intervention

Drug:
• loco-regional anesthesia serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL)
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)
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)
Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Visual analog scale (VAS) score at coughing	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).	Immediately after following thoracoscopic surgery
Secondary	Pain Visual analog scale (VAS) score at coughing	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).	H1 = one hour following thoracoscopic surgery
Secondary	Pain Visual analog scale (VAS) score at coughing	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).	H3 = 3 hours following thoracoscopic surgery
Secondary	Pain Visual analog scale (VAS) score at coughing	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).	H6 = 6 hours following thoracoscopic surgery
Secondary	Pain Visual analog scale (VAS) score at coughing	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).	Day1 = one day following thoracoscopic surgery
Secondary	Pain Visual analog scale (VAS) score at coughing	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).	Day2 = two days following thoracoscopic surgery
Secondary	Pain Visual analog scale (VAS) score at coughing	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).	Day3 = 3 days following thoracoscopic surgery