NCT06695858

Brief Summary

We aim to compare the incidence of post-operative lung atelectasis with erector spinae plane block versus systemic analgesia in patients undergoing bariatric surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

November 15, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

November 16, 2024

Last Update Submit

November 16, 2025

Conditions

Pulmonary AtelectasisBariatric Surgery

Keywords

UltrasoundErector spinaeBariatric surgeryAtelectasis

Outcome Measures

Primary Outcomes (1)

  • Lung atelectasis

    Lung atelectasis (defined as lung ultrasound score ≥2 in any lung region)

    6 hours

Secondary Outcomes (1)

  • NRS

    24 hours

Study Arms (2)

control group

SHAM COMPARATOR

Patients received bilateral sham ultrasound-guided ESPB using 20 mL normal saline on each side.

Drug: ESPB

ESPB group

EXPERIMENTAL

Patients received bilateral ultrasound-guided ESPB using 20 mL bupivacaine 0.25% on each side.

Drug: ESPB

Interventions

ESPBDRUG

Patients received bilateral ultrasound-guided ESPB using 20 mL bupivacaine 0.25% on each side.

ESPB groupcontrol group

Eligibility Criteria

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

You may qualify if:

  • patients with body mass index ≥35 kg/m2
  • scheduled to undergo laparoscopic bariatric surgery.

You may not qualify if:

  • American Society of Anesthesiologists (ASA) physical class\> III.
  • Subjects with contraindications to peripheral regional anesthesia blocks
  • neurological or psychological disorders
  • inability to cooperate
  • pre-existing chronic pain or cognitive dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
An experienced anesthetist will open the envelopes, prepare the local anesthetics, and perform the assigned technique with no further involvement in the study. A blinded investigator (an anesthesia and pain therapy specialist) will be responsible for perioperative data collection, pain assessment during the first 24 postoperative hours, and providing analgesia. All patients were blinded to the assigned technique.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, Asst. professor of anesthesia, Cairo university

Study Record Dates

First Submitted

November 16, 2024

First Posted

November 19, 2024

Study Start

November 15, 2024

Primary Completion

October 18, 2025

Study Completion

October 18, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

EG(1)