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

NCT06621849 | Completed Early Phase 1

• 1 other identifier: MD-259-2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

erector spinae plane block, morphine, hip replacement

Outcome Measures

Primary Outcomes (1)

• walking after the operation

  Time of the first successful trial for walking 10 steps without support

  ,patients will be allowed to walk without support at 6, 12, 18, and 24 hours postoperatively.

Secondary Outcomes (4)

• Postoperative pain score

  24 hours postoperative

• Duration of hospital stay after surgery.

  one week postoperative

• Overall patient satisfaction with pain control.

  the first 24 hours postoperatively

• Time of first rescue

  24 hours postopertive

Study Arms (2)

Group {E}

EXPERIMENTAL

patients in this group will receive Erector spinae plane block on the ipsilateral side of the surgery then 3.5 ml of bupivacaine 0.5% and 0.25 ml of normal saline intrathecal

Procedure: erector spinae plane block

Group {M}

ACTIVE COMPARATOR

patients in this group 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.

Drug: Morphine

Interventions

erector spinae plane block PROCEDURE

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.

Group {E}

Morphine DRUG

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

Also known as: oramorph

Group {M}

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults 18 to 60 yrs. old.
• Both genders.
• ASA I, II.
• Body mass index between 20 to 30 kg per meter square.
• Height between 160 cm and 180 cm

You may not qualify if:

• Patient refusal.
• Age below 18 and above 60 yrs. old.
• Uncooperative patients.
• Known Allergy to the drugs enrolled in the study.
• Body mass index \<30 or \< 20 kg per square meter
• Any contraindication of spinal anaesthesia
• ASA III, IV patients.
• Emergency surgery.
• Neuromuscular disorder interferes with sensations in the lower limbs.
• Drug abuse or using any drug that modifies pain perception.
• Any disability affecting walking capacity rather than the operating joint.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine- Cairo University

Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: September 23, 2024
• Primary Completion: May 23, 2025
• Study Completion: September 23, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

EG (1)