NCT06621849

Effect of Unilateral Erector Spinae Plane Block Versus Intrathecal Morphine on Early Mobilization After Hip Replacement

Completed EARLY_PHASE1 Last updated 2 December 2025

What this trial tests

EARLY_PHASE1 trial testing erector spinae plane block in Pain, Postoperative in 70 participants. Completed in 23 September 2025.

Timeline

23 September 2024

Primary endpoint
23 May 2025

23 September 2025

Quick facts

Lead sponsor	Cairo University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	70
Start date	23 September 2024
Primary completion	23 May 2025
Estimated completion	23 September 2025
Sites	1 location across Egypt

Drugs / interventions tested

• erector spinae plane block — full drug profile →
• Morphine

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Cairo University

Who can join

Adults 18 to 60, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* Preoperative assessment: Patients who fulfill inclusion criteria will be evaluated by medical history, physical examination and clinical laboratory tests which are a complete blood picture (CBC), kidney function tests, liver function tests, international normalized ratio(INR), prothrombin time(PT), and chest X-Ray. An electrocardiograph (ECG) will be done for patients above 40 years old. Patients will be prepared by 8 hours of preoperative fasting, receiving a tablet of Omeprazole 20 mg and Alprazolam 0.5 mg at bedtime the day before surgery.
* All patients will be educated about the standard Numerical Rating Scale (NRS) for pain score of 0-10 (0 = no pain, 10 = the most severe pain) during preanesthetic evaluation visit.
* In our study, 70 patients will be randomly divided into two equal groups, with 35 pt. in each. Spinal anesthesia will be performed at L3-L4 with 3.5 ml of hyper¬baric bupivacaine 0.5% and 0.25 ml normal saline only for the E group or 0.1 mg morphine in 0.25 ml normal saline for the M group (9).

Group {E} will receive ESPB on the ipsilateral side of the surgery then 3.5 ml of bupivacaine 0.5% and 0.25 ml of normal saline intrathecal.

Group {M} will receive 5 ml of subcutaneous lidocaine 1% then 3.5 ml of bupivacaine 0.5% and 0.1 mg of morphine in 0.25 ml of normal saline intrathecal.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.