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Pain, PostoperativeEarly Phase 1NCT06621849

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

A Early Phase 1 study testing erector spinae plane block and Morphine in people with Pain, Postoperative, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative
What is being tested?
erector spinae plane block and Morphine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteEgypt
Study dates
23 Sep 2024to 23 Sep 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Medicine- Cairo University

    Cairo, 11956

Other trials in Egypt

About this study

Official title: The Effect of Unilateral Erector Spinae Plane Block Versus Intrathecal Morphine on Early Mobilization After Total Hip Replacement Under Spinal Anesthesia in Cairo University Hospitals: a Prospective Randomized Clinical Study

  • 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.

Read the detailed 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.

  • Study procedure and anaesthetic technique
  • On the arrival of patients in the operating room, an 18 gauge intravenous cannula will be inserted, and normal saline (10 ml/kg) will be infused as a preload. The patients will be connected to a monitor to record heart rate (HR), non-invasive measurement of systolic blood pressure (SBP), diastolic blood pressure (DBP), main blood pressure, continuous electrocardiogram monitoring (ECG) and oxygen saturation (SpO2). Base line reading will be recorded.
  • All backup measures and equipment for general anesthesia will be ready for urgent use or rescue general anesthesia could be required.
  • In the ESPB group, an ultrasound-guided ESPB will be performed on the ipsilateral side of the surgery while the patient is in lateral position using a linear 6-13 MHz ultrasound probe (SONOSITE Fujif¬ilm S-Nerve, USA) vertical parallel and 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 (SonoPlex®, Pajunk Medizintechnologie, Germany) 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, dissec¬tion of the plane will be observed by injecting a total vol¬ume 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, dissect¬ing the plane between the transverse processes and erector spinae muscles.
  • In the intrathecal morphine group, patients will be injected with 5 ml of lidocaine subcutaneously as a local anesthetic before spinal anesthesia but using the same technique of ESPB regarding position and ultrasound guidance to ensure complete blinding of the patients.
  • Patients from both groups will then receive spinal anaesthesia; intrathecal 3.5 ml hyper¬baric bupivacaine 0.5% and 0.25 ml normal saline for the E group or 0.1 mg morphine in 0.25 ml normal saline for the M group will be administered using a 25-G spinal needle inserted into the L3-L4 space with the patient in the sitting position with complete sterilization. Then patients from both groups will be allowed to be in the supine position. Sensory block will be assessed using a pin prick every 2 minutes while the patient is in the supine position until the proper level will be reached (T10 dermatome), and the Bromage scale will be measured to reach bromage 3 before surgery (11). Any decrease in heart rate below 60/min will be treated with intravenous atropine (0.01 mg/kg), and any decrease in mean arterial pressure below 20% of the basal reading will be treated by fluid bolus and 5 mg intravenous increments of ephedrine.
  • Failure of ESPB technique: Technique failure will be defined as if the correct spread of local anesthetic cranially and caudally from the injection point, dissect¬ing the plane between the transverse processes and erector spinae muscles is not im¬mediately visualized (10). Those patients were not included in our study and will be replaced by other patients.
  • Failure of spinal anesthesia: Technique failure will be defined as if the T10 sensory level and/or Bromage 3 scale are not reached after 20 min. of spinal injection (11). So rescue general anesthesia will be initiated; those patients not included in our study will be replaced by others.
  • For both groups, oral paracetamol 1 gm./6 hours and sustained-release diclofenac 75 mg/12 hours will be administered postoperatively regularly until hospital discharge.
  • IF any patient enrolled in our study complains of a pain score > 3 with regard to NPS in spite of the previously mentioned protocol for pain management, a rescue of 0.07 mg/kg IV morphine sulphate will be administrated, then NPS will be reassessed 15 minutes later if it is still > 3 a rescue 0.05 mg/kg IV morphine sulphate will be administered, which can be repeated any time postoperatively until NRS is 3 or less, provided that total morphine consumption does not exceed 0.2 mg/kg/4 hours (12).
Keywords
erector spinae plane block, morphine, hip replacement
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erector spinae plane blockProcedure or surgery

    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.

  • MorphineDrug

    Also called oramorph

    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

Study groups in NCT06621849
Study groupRoleWhat they receive
Group {E}Experimentalpatients 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
Receives: Procedure: erector spinae plane block
Group {M}Active comparatorpatients 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.
Receives: Drug: Morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. walking after the operation

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

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

Secondary outcomes (4)
  1. Postoperative pain score

    Postoperative pain score at 2, 4, 8, 12, and 24 hours.

    Measured: 24 hours postoperative

  2. Duration of hospital stay after surgery.

    Duration of hospital stay after surgery.

    Measured: one week postoperative

  3. Overall patient satisfaction with pain control.

    • The post-operative pain score and acute postoperative pain within the first 24 hours postoperatively will be assessed using the NRS (0-10), where 0 = no pain and 10 = worst pain, at 2, 4, 8, 12, and 24 hours postoperatively.

    Measured: the first 24 hours postoperatively

  4. Time of first rescue

    Time of first rescue: 0.07 mg/kg of morphine required by the patient.

    Measured: 24 hours postopertive

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start23 Sep 2024
  3. Primary completion23 May 2025
  4. Study completion23 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06621849
Sponsor's protocol ID
MD-259-2024
Status last verified
Nov 2025
First submitted
23 Sep 2024
Last updated
2 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Al-Latif AMHAA, Hassan AA, Farahat OMA, Salem AKS, Ghaleb KHM. The Effect of Unilateral Erector Spinae Plane Block With Dexmedetomidine as an Additive Versus Intrathecal Morphine on Early Mobilization After Total Hip Replacement Under Spinal Anesthesia in Cairo University Hospitals: A Randomized Controlled Trial. Anesthesiol Res Pract. 2026 Jun 30;2026:9919921. doi: 10.1155/anrp/9919921. eCollection 2026.

    PubMed 42389062

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing erector spinae plane block and Morphine in people with Pain, Postoperative, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

walking after the operation (time frame: ,patients will be allowed to walk without support at 6, 12, 18, and 24 hours postoperatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06621849, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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