NCT03839160

Brief Summary

Thoracotomy is considered the most painful surgical procedure. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain. In this study, investigators aim to ascertain the efficacy of SAPB in thoracotomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2017

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

November 23, 2017

Last Update Submit

May 10, 2021

Conditions

Pain, PostoperativeAnesthesiaThoracotomy

Outcome Measures

Primary Outcomes (1)

  • visual analog scale

    Adult Pain Visual Analog Scale

    Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation

Secondary Outcomes (6)

  • Hemodynamic profile - Heart rate

    At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation

  • Hemodynamic profile - blood pressure

    At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation

  • Hemodynamic profile - SpO2

    At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation

  • Opioids-related side effects - nausea

    At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation

  • Catheter-related profile

    at Day 1, Day2 and Day 3 post-operation

  • +1 more secondary outcomes

Study Arms (2)

SAPB group. Group S

ACTIVE COMPARATOR

In this group, serratus anterior plane block (SAPB) was performed before extubation with injection of 30 ml of 0.25% bupivacaine hydrochloride followed by 0.1ml/kg/hr of 0.12% bupivacaine hydrochloride. In addition to SAPB, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.

Procedure: Serratus anterior plane blockDrug: Intravenous patient-controlled-analgesia morphine

Control group. Group C

PLACEBO COMPARATOR

In this group, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.

Drug: Intravenous patient-controlled-analgesia morphine

Interventions

Serratus anterior plane blockPROCEDURE

Serratus anterior plane block was applied in Group S. It was performed at the end of the operation following the skin closure, while the patient lay on his side with his arm above the head. After proper site cleaning, the first and second ribs were identified with a linear probe in the midclavicular line. The USG probe was advanced caudally in the sagittal plane, and the fourth and fifth ribs were visualized. The USG probe was then directed posteriorly and the serratus, latissimus dorsi and intercostal muscles were visualized. Bupivacaine 0.25% 30 mL was administered to the lower plane of the serratus muscle through an inserted catheter under the guidance of USG through the in-line technique. Afterwards, 0.12% bupivacaine hydrochloride was maintained at the rate of 0.1ml/kg/hr.

Also known as: Serratus plane block
SAPB group. Group S
Intravenous patient-controlled-analgesia morphineDRUG

Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.

Also known as: PCIA
Control group. Group CSAPB group. Group S

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I-II
  • BMI 18-28kg/m2
  • Wedge incision and lobectomy

You may not qualify if:

  • Uncontrolled hypertension or chronic conditions
  • History of opioid dependence
  • Allergy to bupivacaine hydrochloride
  • Severe bleeding during operation or post operation
  • Inability to communicate with investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Jing Cang, MD

    Shanghai Zhongshan Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2017

First Posted

February 15, 2019

Study Start

December 1, 2019

Primary Completion

December 31, 2020

Study Completion

May 1, 2021

Last Updated

May 13, 2021

Record last verified: 2021-05

Locations

CN(1)