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

NCT06621849 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-12-02

No results posted yet for this study

Summary

* 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.

Conditions

  • Pain, Postoperative

Interventions

PROCEDURE

erector spinae plane block

In the erector spinae plane block (group E), an ultrasound-guided block will be performed on the ipsilateral side of the surgery while the patient is in lateral position 3-5 cm from the midline (10). Moving cephalic from the sacrum, we will identify the L5, L4, and L3 transverse processes and erector spinae muscles posteriorly. A 21 G and 70mm length needle will be directed in-plane, and the needle tip will be positioned anterior to the erector spinae muscle at the corner of the transverse process. After the initial saline injection, dissection of the plane will be observed by injecting a total volume of 20 ml composed of 10 micrograms dexmedetomidine in 2ml of normal saline and 18 ml of bupivacaine 0.25%, which is far from the toxic dose (10). Correct placement is defined as the spread of local anesthetic cranially and caudally from the injection point, dissecting the plane between the transverse processes and erector spinae muscles.

DRUG

Morphine

patients 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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2025-05-23
Completion
2025-09-23

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06621849 on ClinicalTrials.gov