NCT07138781

Brief Summary

The aim of this study is to evaluate the role of ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

August 23, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

August 17, 2025

Last Update Submit

February 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to the 1st rescue analgesia

    Time to the first request for the rescue analgesia will be recorded from end of surgery to first dose of morphine administrated.

    48 hours postoperatively

Secondary Outcomes (6)

  • Intraoperative fentanyl consumption

    Intraoperatively

  • Total morphine consumption

    48 hours postoperatively

  • Degree of pain

    48 hours postoperatively

  • Mean arterial pressure

    Till the end of surgery (Up to 2 hours)

  • Heart rate

    Till the end of surgery (Up to 2 hours)

  • +1 more secondary outcomes

Study Arms (2)

Group K

EXPERIMENTAL

Patients will receive 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) as a study group.

Drug: Ketamine

Group C

ACTIVE COMPARATOR

Patients will receive 29 ml bupivacaine 0.25% + 1 ml saline as a control group.

Drug: 29 ml bupivacaine 0.25% + 1 ml saline

Interventions

Patients will receive 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg).

Group K

Patients will receive 29 ml of bupivacaine 0.25% + 1 ml of saline.

Group C

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-III.
  • Scheduled for open thoracotomy.

You may not qualify if:

  • Patients with neurological or intellectual disability.
  • Infection at the injection site.
  • Opioid addiction.
  • Allergic reaction to local anesthetics.
  • Coagulation abnormalities.
  • Drug abuse.
  • Pregnancy.
  • Severe liver and/or renal failure.
  • Severe cardiovascular problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

KetamineBupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnilidesAmidesAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

August 17, 2025

First Posted

August 24, 2025

Study Start

August 23, 2025

Primary Completion

February 17, 2026

Study Completion

February 17, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations