Erector spinae plane block versus low dose ketamine-dexmedetomidine intravenous infusion as opioid free analgesia for modified radical mastectomy

A randomized comparative study of erector spinae plane block versus low dose ketamine-dexmedetomidine intravenous infusion as intraoperative opioid free analgesia for modified radical mastectomy

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202209505436358

Enrollment

Registered

2022-09-09

Start date

2022-09-10

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Anaesthesia

Interventions

Erector Spinae Plane block

Low dose ketamine Dexmedetomidine Intravenous infusion

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1- Female. 2- Age group 20 – 60 years old. 3- ASA physical status I-II. 4- Scheduled for modified radical mastectomy.

Exclusion criteria

Exclusion criteria: 1- Male. 2- Age 60 years old. 3- ASA physical status >II. 4- Mental illness. 5- Drug abuse. 6- Patient refusal. 7- Bilateral mastectomy or additional surgical reconstruction procedures.

Design outcomes

Primary

Measure	Time frame
Total postoperative 24-hour morphine consumption. It is the sum of total rescue morphine boluses in milligrams given on request when NRS equals or becomes more than 4 ,after ketorolac and paracetamol, throughout the postoperative 24 hours.	—

Secondary

Measure	Time frame
Anesthetic consumption. The total amount of isoflurane inhalational anesthetic consumption in milliliters adjusted to keep hemodynamics within twenty percent of its basal values throughout the surgery. ;Time to awakening. It is the time in minutes from end of surgery till spontaneous eye opening or on verbal command.;Pain scores during rest. It is pain score assessed by numerical rating scale (NRS) at rest as 0 for no pain till 10 for the worst pain imaginable starting from regaining full consciousness;Pain scores during arm movement. It is pain score assessed by numerical rating scale (NRS) during arm movement as 0 for no pain till 10 for the worst pain imaginable starting from regaining full consciousness.;Duration of analgesia. It is the time in hours elapsed from administration of the analgesic medications till NRS equals or becomes more than 4.;Change of serum cortisol level postoperatively. It is the serum level of cortisol in micrograms per deciliter after regaining consciousness compared to the basal levels before the start of general anesthesia.;Severity of postoperative nausea and vomiting. It is nausea assessed by 4-point categorical scale (0= none, 1= mild, 2= moderate, 3= severe) depending on its frequency, intensity, duration and progression to vomiting. When vomiting occurs or nausea becomes moderate or severe, IV metoclopramide 10 mg will be given.	—

Measure

Time frame

Anesthetic consumption. The total amount of isoflurane inhalational anesthetic consumption in milliliters adjusted to keep hemodynamics within twenty percent of its basal values throughout the surgery. ;Time to awakening. It is the time in minutes from end of surgery till spontaneous eye opening or on verbal command.;Pain scores during rest. It is pain score assessed by numerical rating scale (NRS) at rest as 0 for no pain till 10 for the worst pain imaginable starting from regaining full consciousness;Pain scores during arm movement. It is pain score assessed by numerical rating scale (NRS) during arm movement as 0 for no pain till 10 for the worst pain imaginable starting from regaining full consciousness.;Duration of analgesia. It is the time in hours elapsed from administration of the analgesic medications till NRS equals or becomes more than 4.;Change of serum cortisol level postoperatively. It is the serum level of cortisol in micrograms per deciliter after regaining consciousness compared to the basal levels before the start of general anesthesia.;Severity of postoperative nausea and vomiting. It is nausea assessed by 4-point categorical scale (0= none, 1= mild, 2= moderate, 3= severe) depending on its frequency, intensity, duration and progression to vomiting. When vomiting occurs or nausea becomes moderate or severe, IV metoclopramide 10 mg will be given.

—

Countries

Egypt

Contacts

Public ContactAhmed Medhat

Committee

dr.a_medhat88@hotmail.com201551034402

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026