CClinicalTrials.gg
Status unknownNCT04648345Updated Dec 1, 2020

Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Analgesia in Laparoscopic Cholecystectomy

An interventional study of Erector spinal plane block in Analgesia, sponsored by Beijing Tsinghua Chang Gung Hospital. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-12-01.

Sponsored by Beijing Tsinghua Chang Gung Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

Purpose: to evaluate the efficacy and safety of erector spinal block (ESB) for analgesia in laparoscopic cholecystectomy(LC).

Method: This study is a randomized, single-blind, controlled clinical trial. Pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. Vertebral side block will be performed in the VSB group. And the control group will receive local anaesthesia after the surgery. Intraoperative and postoperative analgesia effect and side effects will be compared between the three groups.

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Conditions studied

  • Analgesia

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Keywords

  • erector spinal plane block
  • analgesia
  • laparoscopic cholecystectomy
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In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's planned enrollment of 90 is above the median of 78 across 1,024 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 96 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status 1-3
  • Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • patient refusal
  • pregnancy
  • history of allergy to study drugs
  • neurological and cognitive disorders
  • coagulopathy
  • chronic pain disorders
  • infections at the injection site
  • history of abdominal surgery
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Erector spinal plane block group (ESPB group)

    After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group.

    Procedure: Erector spinal plane block

  • Active comparator
    Vertebral side block group (VSB group)

    After induction of general anesthesia, pre-operative ultrasound-guided bilateral vertebral side block will be performed in the VSB group.

    Procedure: Erector spinal plane block

  • Placebo comparator
    Local block group (LB group)

    Local block will be performed at the surgical incisions after the surgery under general anesthesia.

    Procedure: Erector spinal plane block

Interventions

  • ProcedureErector spinal plane block

    After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block/ vertebral side block will be performed in the ESPB/VSB group. Local block will be performed at the surgical incisions after the surgery under general anesthesia. All the intervention will be performed without patients' awareness.

    Also known as: Vertebral side block, Local block

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What researchers measure

Primary outcomes

  1. Pain intensity at rest(Hour 2)

    Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest two hours after the surgery.

    Time frame: Hour 2

  2. Pain intensity at rest (Hour 6)

    Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest six hours after the surgery.

    Time frame: Hour 6

  3. Pain intensity at rest (Hour 24)

    Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest 24 hours after the surgery.

    Time frame: Hour 24

Secondary outcomes

  1. The overall dose of remifentanil

    The overall dose of remifentanil used in the surgery.

    Time frame: During the surgery

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04648345
Lead sponsor
Beijing Tsinghua Chang Gung Hospital
Responsible party
Sponsor
First posted
Dec 1, 2020
Start date
Dec 2020 (estimated)
Primary completion
Mar 2021 (estimated)
Completion
May 2021 (estimated)
Last update
Dec 1, 2020

Study contacts

Siyi YAN, MD
Contact
yansiyi03@hotmail.com
86+010-56119610
Chen Yu, MD
Contact
yca01089@btch.edu.cn
86+010-56119353

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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