NCT07149584

Brief Summary

The study is planned as a single-center prospective randomized study and includes patients undergoing laparoscopic cholecystectomy. The aim of this study is to compare postoperative analgesic efficacy of erector spinae plane block and thoracic paravertebral block. Primary outcome is 24-hour postoperative opioid consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

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

August 23, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2026

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

August 23, 2025

Last Update Submit

February 26, 2026

Conditions

Pain, Acute Postoperative

Keywords

postoperative painerector spinal plane blockthoracic paravertebral block

Outcome Measures

Primary Outcomes (1)

  • Tramadol consumption

    amount of postoperative 24-hour tramadol consumption

    postoperative 24 hours

Secondary Outcomes (8)

  • Amount of fentanyl

    during surgery

  • Static and dynamic pain score

    postoperative 24 hours

  • First rescue analgesic time

    postoperative 24 hours

  • Number of patients required rescue analgesic.

    postoperative 24 hours

  • Nausea and vomiting

    postoperative 24 hours

  • +3 more secondary outcomes

Study Arms (3)

Group 1: ESPB

EXPERIMENTAL

Erector spinal plane block

Procedure: ESPB

Group 2: TPVB

EXPERIMENTAL

Thoracic paravertebral block

Procedure: TPVB

Group 3: IV

EXPERIMENTAL

intravenous analgesia

Procedure: IV

Interventions

ESPBPROCEDURE

10 mL of 0.375% bupivacaine is injected on each side between the deep fascia of the erector spinae muscle and the transverse process. Additionally, tramadol is administered via intravenous patient-controlled analgesia.

Group 1: ESPB
TPVBPROCEDURE

10 mL of 0.375% bupivacaine is injected on each side between the superior costotransverse ligament and the pleura.

Group 2: TPVB
IVPROCEDURE

Tramadol is administered via intravenous patient-controlled analgesia.

Group 3: IV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective cholecystectomy
  • Age \>18years
  • American Society of Anesthesiologists classification I-III

You may not qualify if:

  • Presence of contraindications for using regional anesthesia ( not having patient approval, bleeding diathesis or use of anticoagulants, infection at the injection site, and allergy to local anesthetics)
  • Chronic analgesic use
  • Open cholecystectomy or conversion to open cholecystectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Özlem Turhan

    Istanbul Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Anesthesiologist

Study Record Dates

First Submitted

August 23, 2025

First Posted

September 2, 2025

Study Start

September 1, 2025

Primary Completion

February 23, 2026

Study Completion

February 23, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

TU(1)