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

NCT04222010 | Completed Phase 3

• 1 other identifier: PI2019_843_0051
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local; Pain, Postoperative

Keywords

Anesthesia, Local; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain Visual analog scale (VAS) score at coughing

  H1 = one hour following thoracoscopic surgery

• Pain Visual analog scale (VAS) score at coughing

  H3 = 3 hours following thoracoscopic surgery

• Pain Visual analog scale (VAS) score at coughing

  H6 = 6 hours following thoracoscopic surgery

• Pain Visual analog scale (VAS) score at coughing

  Day1 = one day following thoracoscopic surgery

• Pain Visual analog scale (VAS) score at coughing

  Day2 = two days following thoracoscopic surgery

Study Arms (3)

serratus loco-regional anesthesia

EXPERIMENTAL

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)

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

paravertebral bloc Loco-regional anesthesia

EXPERIMENTAL

patient who underwent thoracoscopic surgery will be assigned to paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL)

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

serratus and paravertebral bloc Loco-regional anesthesia

EXPERIMENTAL

patient who underwent thoracoscopic surgery will be assigned to serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL)

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

Interventions

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

serratus 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.

paravertebral bloc 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.

serratus and paravertebral bloc Loco-regional anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Related Publications (1)

• Leviel F, Fourdrain A, Delatre F, De Dominicis F, Lefebvre T, Bar S, Alshatri HY, Lorne E, Georges O, Berna P, Dupont H, Meynier J, Abou-Arab O. S erratus anterior plane block alone, paravertebral block alone and their combination in video-assisted thoracoscopic surgery: the THORACOSOPIC double-blind, randomized trial. Eur J Cardiothorac Surg. 2024 Mar 29;65(4):ezae082. doi: 10.1093/ejcts/ezae082.

  PMID: 38548664 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pascal Berna, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Emmanuel Lorne, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Alex Fourdrain, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Florent Leviel, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: January 9, 2020
• Study Start: January 2, 2020
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)