NCT07740382

Brief Summary

This study evaluates respiratory recovery as a multidimensional construct using clinically relevant and measurable parameters, including LUS, diaphragmatic excursion, oxygen requirement, and PPCs. The investigators hypothesize that bilateral ESP block improves postoperative respiratory function compared with EOIP block following open hepatic surgery. The investigators further hypothesize that this improvement is mediated, in part, by superior analgesia.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jul 2026Jan 2027

Study Start

First participant enrolled

July 1, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 18, 2026

Last Update Submit

July 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Right diaphragmatic excursion

    Right diaphragmatic excursion will be measured during quiet tidal breathing in the semi-recumbent position using M-mode ultrasonography through a right subcostal hepatic acoustic window. Three consecutive respiratory cycles will be recorded and averaged at each assessment measured in cm.

    Baseline, and 1, 6, and 24 hours after surgery.

Secondary Outcomes (5)

  • Mean postoperative pain intensity at rest, during coughing or deep breathing

    Pain scores at rest (PACU 30 minutes, 2, 6, 12, and 24 hours) and during coughing or deep breathing (6, 12, and 24 hours).

  • Mean cumulative postoperative opioid consumption and Mean intraoperative opioid consumption

    First 24 postoperative hours.

  • Number of participants requiring supplemental oxygen

    First 24 postoperative hours.

  • Number of participants with early postoperative pulmonary complications

    Within 7 postoperative days.

  • Mean lung ultrasound score

    During the first 24 postoperative hours at predefined assessment time points.

Study Arms (2)

The external oblique intercostal plane (EOIP) block

ACTIVE COMPARATOR

newer fascial plane block that targets the thoracoabdominal nerves within the fascial plane between the external oblique and intercostal muscles. Its dermatomal coverage, typically spanning T6 to T10-T11, corresponds well with common upper abdominal surgical incisions. Emerging randomized data indicate that EOIP block provides effective postoperative analgesia and may be faster and technically easier to perform than deeper blocks. In open liver surgery, where subcostal and J-shaped incisions are frequently used, the EOIP block appears anatomically well-matched to the surgical field .

Procedure: Ultrasound-guided bilateral external oblique intercostal plane (EOIP) block

The erector spinae plane (ESP) block

ACTIVE COMPARATOR

gained widespread use due to its relative technical simplicity, safety profile, and potential to provide both somatic and visceral analgesia. Meta-analytic evidence suggests that ESP block reduces postoperative opioid consumption and pain scores in abdominal surgery compared with control or alternative techniques.

Procedure: Ultrasound-guided bilateral erector spinae plane (ESP) block

Interventions

Bilateral ESP block * after induction of general anesthesia and before surgical incision. * T7 or T8 transverse process, selected consistently by protocol. * high-frequency linear probe when feasible; curvilinear probe in larger habitus. In-plane cranial-to-caudal or caudal-to-cranial approach to the fascial plane deep to erector spinae muscle and superficial to the transverse process. * Injectate: 20 mL of 0.25% bupivacaine per side after negative aspiration; hydrodissection used to confirm correct plane. Bilateral EOIP block * after induction of general anesthesia and before surgical incision. * ultrasound-guided injection into the fascial plane between the external oblique muscle and the intercostal muscle/external intercostal membrane near the 6th-8th intercostal spaces on each side, following the institutional standardized approach. * Injectate: 20 mL of 0.25% bupivacaine per side Safter negative aspiration.

The external oblique intercostal plane (EOIP) block

An ultrasound-guided bilateral ESP block will be performed after induction of general anaesthesia and before surgical incision. The block will be administered at the T7 or T8 transverse process using an in-plane ultrasound-guided approach. Twenty millilitres of 0.25% bupivacaine will be injected on each side into the fascial plane deep to the erector spinae muscle and superficial to the transverse process after negative aspiration. Correct spread of local anaesthetic will be confirmed by hydrodissection.

The erector spinae plane (ESP) block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18-75 years
  • Adult with American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective hepatic surgery via upper abdominal incisions will be eligible.
  • All participants will be required to understand the Numeric Rating Scale (NRS) and provide informed consent.

You may not qualify if:

  • Patient refusal
  • Coagulopathy (INR\>1.4 or platelet count\<8 x 104)
  • Contraindications to fascial plane blocks
  • Infection at the puncture site
  • Known allergy to study medications
  • Chronic opioid use or chronic pain syndromes
  • Severe chronic respiratory failure requiring home oxygen or noninvasive ventilation
  • Pregnancy
  • Body mass index\>40 kg/m²
  • When ultrasound imaging will be deemed unreliable
  • Emergency surgery
  • Hemodynamic instability
  • Reoperation during the same hospital admission.
  • Patients scheduled preoperatively for elective postoperative mechanical ventilation or planned ICU intubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Liver Institute, Menoufia University

Alexandria, Sbein-Elkom, 32511, Egypt

RECRUITING

MeSH Terms

Interventions

Dental OcclusionParapsychology

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaBehavioral SciencesBehavioral Disciplines and Activities

Central Study Contacts

Nevine Mostafa Soliman

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

July 18, 2026

First Posted

July 31, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations