The Effect of Ultrasound-guided Erector Spinae Block and Intraoperative Intercostal Nerve Block on Postoperative Analgesia in Thoracic Surgery

NCT ID: NCT04581616

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2022-10-16

Brief Summary

This study aims to compare the effect of ultrasound-guided erector spinae plane block and interthoracic intercostal nerve block in thoracic surgery. Interthoracic intercostal nerve block is a routine procedure during the surgery by the surgeon in our hospital, and ultrasound-guide erector spinae plane block is a relative new developed regional analgesia technique introduced since 2016 and mainly done by anesthesiologists. Both technique provide analgesic effect to some extent and reduce opiate consumption and side effects. However, no previous literature or research compare the effect of these two technique in thoracic surgery. The primary endpoint of our study is compare morphine consumption and pain score between patients undergo ESP block and patients undergo ICNB after thoracic surgery; the second endpoint is to compare the recovery condition evaluated by QoR-15 questionaire 24 hours after surgery.

Detailed Description

Sample size estimation is based on our APS team data, in which the average cumulative morphine consumption in patients underwent VATS surgery with ICNB was calculated. The mean cumulative morphine consumption was 15±8 mg of patients underwent VATS with ICNB. We assume the difference between ICNB and ESPB group reach 5 mg and aim for a power of 95 % and a risk of 0.05 for a type-1 error, at least 42 for each group needing to be recruited. 50 patients for each group, total 100 patients will be collected to avoid dropouts. Patient will be allocated to one of the trial groups using a computer-generated random number table once the consent was approved. First group is ICNB group and the second group is ESPB group.

The general anesthesia agents, induction process and routine care are the same for both groups. Once aforementioned routine cares are done, the patient will be turn into lateral decubitus position. Echo-guided ESP block will be performed after patients are turned into lateral decubitus position in ESP group; on the other side, local anesthetics will be injected at incision site and intrathoracic intercostal nerve block will be performed in ICNB group right after the surgeon makes the incision site and get into chest cavity.

Pain score (VAS) and cumulative morphine consumption will be recorded in PACU, postoperative 24H, 48H, and before discharge. Recovery condition will be evaluated via QoR-15 questionnaire in postoperative 24H, furthermore, we will follow up the patient's pain and recovery status 3 months after the operation. After collecting above data, the effect of ESP group and ICNB group on acute pain relieve, chronic pain control and recovery enhancement will be evaluated.

Conditions

Anesthesia; Postoperative Pain; Ultrasound Therapy; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

ICNB group

After patient was turned to lateral decubitus position, local anesthetics is injected around incision site and ICNB is performed once after surgeon geys into chest cavity.

Group Type: ACTIVE_COMPARATOR

Intrathoracic Intercostal Nerve Block

Intervention Type: PROCEDURE

Injection of local anesthetic into the subcostal groove, to achieve analgesia for chest region.

ESPB group

After patient was turned to lateral decubitus position, ESPB is performed via ultrasound guided technique before sound incision.

Group Type: EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type: PROCEDURE

Injection of local anesthetic in the plane deep to the erector spinae muscles and superficial to the transverse processes, to achieve analgesia for chest region.

Interventions

Intrathoracic Intercostal Nerve Block

Injection of local anesthetic into the subcostal groove, to achieve analgesia for chest region.

Intervention Type: PROCEDURE

Erector Spinae Plane Block

Injection of local anesthetic in the plane deep to the erector spinae muscles and superficial to the transverse processes, to achieve analgesia for chest region.

Intervention Type: PROCEDURE

Other Intervention Names

ICNB; ESPB

Eligibility Criteria

Inclusion Criteria

• Patient receive thoracic surgery
• BMI between 18.5~30.0 kg.m-2

Exclusion Criteria

• Pregnant woman
• Patient with any one of following chronic organ dysfunction: Heart failure (NYHA score =III、IV); Renal failure (eGFR< 60 ml.min-1.1.73m-2)
• Arrhythmia
• Ongoing infection or septic patient
• Chronic use of analgesic with addiction
• Coagulopathy that is not suitable for regional anesthesia performance
• Thoracic surgery that is not suitable for placement of endotracheal blocker tube
• Redo surgery

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202008040RINC

Identifier Type: -

Identifier Source: org_study_id