NCT05751304

Brief Summary

Orthopedic anaesthesia and acute postoperative pain management, two anesthesiology subspecialties,are getting more credit for reducing hospital stays, promoting functional recovery and improving patient satisfaction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

February 20, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

February 20, 2023

Last Update Submit

February 20, 2023

Conditions

Bone Fracture

Outcome Measures

Primary Outcomes (1)

  • comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery

    comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery.

    1 year

Study Arms (2)

Group D

ACTIVE COMPARATOR

(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 5μg dexametomidine.

Drug: Dexmedetomidine

Group K

ACTIVE COMPARATOR

(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 0.1 mg/kg ketamine.

Drug: Ketamine

Interventions

DexmedetomidineDRUG

(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 5μg Dexametomidine.

Group D
KetamineDRUG

(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 0.1 mg/kg ketamine.

Group K

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The study will include 100 adult patients (18 to 50 years old) with ASA physical status class I and class II undergoing orthopedic lower limb surgeries under itrathecal anathesia .

You may not qualify if:

  • Patient refusal.
  • Drug abuse.
  • Patient with neurological, psychiatric or neuromuscular disease.
  • Chronic pain on medicine.
  • Known allergy to the study medications.
  • Patients e contraindications to intrathecal anesthesia .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.

    PMID: 22227789BACKGROUND

  • Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.

    PMID: 16698416BACKGROUND

  • Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.

    PMID: 11460814BACKGROUND

  • Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. doi: 10.1213/01.ane.0000268145.52345.55.

    PMID: 17578977BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Interventions

DexmedetomidineKetamine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

zeyad A Ali, Resident

CONTACT

01159596946zeyadahmed@med.sohag.edu.eg

Ahmed E Abd Elrahman, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A comparative study between intrathecal dexmedetomidine VS ketamine with intrathecal bupivacaine in orthopedic lower limb surgeries.

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 2, 2023

Study Start

March 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 28, 2024

Last Updated

March 2, 2023

Record last verified: 2023-02

Locations

EG(1)