Total Hip Arthroplasty (THA)NCT07240961
Lumbal Erector Spinae Plane Block for Pain Management After Total Hip Arthroplasty
A study testing Lumbal Erector Spinae Plane Block and intravenous pain killers in people with Total Hip Arthroplasty (THA), run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
The Erector Spinae Plane (ESP) block or spinal erector block was first described in September 2016 by a Canadian team. It's a block that was initially used for the treatment of chronic thoracic neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- Lumbal Erector Spinae Plane Block and intravenous pain killers
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Nov 2025to 7 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary total hip arthroplasty with lateral approach and under general anesthesia .
Who cannot join
- • Contraindication or refusal to regional anesthesia
- Contraindication to non-steroidal anti-inflammatory (NSAID's)
- Allergy to opioids
- Allergy to paracetamol
- Creatinine clearance < 30ml/min
- Weight<50 kg or >100kg
Show all 9Show fewer
- Psychiatric disorders and difficulty of communication
- Lower limb neurological deficit
- Patients undergoing bilateral or revision total hip replacement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
KAABACHI OLFA contact
Tunisia1 site, 1 recruiting
- Recruiting
Kassab Orthopedic Institute
Manouba, 2010
KAABACHI OLFA OLFA, PROFESSOR, 0021098317381, olfa.kaabach@gmail.com
About this study
Official title: Ultrasound-Guided Lumbal Erector Spinae Plane Block on Postoperative Pain Management After Total Hip Arthroplasty
The Erector Spinae Plane (ESP) block or spinal erector block was first described in September 2016 by a Canadian team. It's a block that was initially used for the treatment of chronic thoracic neuropathic pain. The ESP block is one of the inter-fascicular blocks and it's an easy-to-perform technique.In the literature, it has been reported that Lumbar ESPB provides effective analgesia after a hip surgery.
The purpose of this prospective randomized study was to compare the analgesic effects of the ultrasound-guided lumbar Erector Spinae Plane block on postoperative pain management versus the multimodal analgesia after total hip arthroplasty.
Read the detailed description
Patients aged more than 18 years, ASA I-III scheduled for primary total hip arthroplasty with lateral approach and under general anesthesia Patients were randomly assigned, into 1 of 2 groups, namely, group ESPBL and group Placebo, using sealed envelopes
- For ESPBL group: Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block.
- For Placebo group: patients had multimodal analgesia without lumbar ESP block Patients will be transferred to continuous care unit for 24 hours.
Post-operative analgesia will include:
- Paracetamol 1g IV every 8 hours for 1 day then oral paracetamol 1g every 8 hours for 4 weeks.
- Diclofenac sodium(50mg) 1 tablet x 2 per day for 5 days.
- PCA morphine (Patient Controlled Analgesia), as a rescue analgesia, programmed as: Bolus of 1mg/ refractory period of 10 min/ maximum dose set up at 10mg every 12h.
The primary outcome of the study is to compare postoperative opioids consumption in the first 24 postoperative hours.
Secondary endpoints:
Secondary outcomes are: intraoperative opioid consumption, postoperative pain scores, sitting position and adverse effects related to opioids.
- Conditions
- Total Hip Arthroplasty (THA)
- Being tested
- Lumbal Erector Spinae Plane Block, intravenous pain killers
- Keywords
- hip arthroplasty, Lumbal Erector Spinae Plane Block, pain managment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbal Erector Spinae Plane BlockProcedure or surgery
Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block.
intravenous pain killersProcedure or surgery
intravenous pain killers
| Study group | Role | What they receive |
|---|---|---|
| hip arthroplasty with nerve block | Active comparator | Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block Receives: Procedure: Lumbal Erector Spinae Plane Block |
| hip arthroplasty with intravenous pain killers | Placebo comparator | intravenous pain killers Receives: Procedure: intravenous pain killers |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
total morphine dose
Measured: Day 1
Secondary outcomes (6)
pain scores
numerical pain rating scale [1 to 10 worse outcome]
Measured: Hour 2, Hour 4, Hour 6, Hour 12, Hour 18, Hour 24 and on Day 2 and Day 7.
intraoperative opioid consumption
total fentanyl dose
Measured: end of surgery
pain on sitting position
numerical pain rating scale [1 to 10 worse outcome]
Measured: Day 1
QR 9 score
quality of recovery score [0 to 18 best outcome]
Measured: Day 2
ROM
Range of mouvement [0° to 90°best outcome]
Measured: Day 1
pain during walk
numerical pain rating scale [1 to 10 worse outcome]
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Nov 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion7 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olfa kaabachi, MD, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240961
- Sponsor's protocol ID
- IMKO-CE 115/2024
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Lumbal Erector Spinae Plane Block on Postoperative Pain Management After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07240961
- Acronym / sponsor ID
- IMKO-CE 115/2024
- Conditions
- Total Hip Arthroplasty (THA)
- Keywords
- hip arthroplasty, Lumbal Erector Spinae Plane Block, pain managment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 7 Jul 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Erector Spinae Plane (ESP) block or spinal erector block was first described in September 2016 by a Canadian team. It's a block that was initially used for the treatment of chronic thoracic neuropathic pain. The ESP block is one of the inter-fascicular blocks and it's an easy-to-perform technique.In the literature, it has been reported that Lumbar ESPB provides effective analgesia after a hip surgery.
The purpose of this prospective randomized study was to compare the analgesic effects of the ultrasound-guided lumbar Erector Spinae Plane block on postoperative pain management versus the multimodal analgesia after total hip arthroplasty.
Detailed description
Patients aged more than 18 years, ASA I-III scheduled for primary total hip arthroplasty with lateral approach and under general anesthesia Patients were randomly assigned, into 1 of 2 groups, namely, group ESPBL and group Placebo, using sealed envelopes
- For ESPBL group: Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block.
- For Placebo group: patients had multimodal analgesia without lumbar ESP block Patients will be transferred to continuous care unit for 24 hours.
Post-operative analgesia will include:
- Paracetamol 1g IV every 8 hours for 1 day then oral paracetamol 1g every 8 hours for 4 weeks.
- Diclofenac sodium(50mg) 1 tablet x 2 per day for 5 days.
- PCA morphine (Patient Controlled Analgesia), as a rescue analgesia, programmed as: Bolus of 1mg/ refractory period of 10 min/ maximum dose set up at 10mg every 12h.
The primary outcome of the study is to compare postoperative opioids consumption in the first 24 postoperative hours.
Secondary endpoints:
Secondary outcomes are: intraoperative opioid consumption, postoperative pain scores, sitting position and adverse effects related to opioids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hip arthroplasty with nerve block | Active comparator | Procedure: Lumbal Erector Spinae Plane BlockLumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block |
| hip arthroplasty with intravenous pain killers | Placebo comparator | Procedure: intravenous pain killersintravenous pain killers |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary total hip arthroplasty with lateral approach and under general anesthesia .
Key exclusion criteria (9 listed)
- • Contraindication or refusal to regional anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbal Erector Spinae Plane BlockLumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block. | Procedure or surgery | hip arthroplasty with nerve block |
| intravenous pain killersintravenous pain killers | Procedure or surgery | hip arthroplasty with intravenous pain killers |
Primary outcome
morphine consumption
Time frame: Day 1
total morphine dose
6 secondary outcomes
pain scores
Time frame: Hour 2, Hour 4, Hour 6, Hour 12, Hour 18, Hour 24 and on Day 2 and Day 7.
intraoperative opioid consumption
Time frame: end of surgery
pain on sitting position
Time frame: Day 1
QR 9 score
Time frame: Day 2
ROM
Time frame: Day 1
pain during walk
Time frame: Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Total Hip Arthroplasty (THA)
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)
Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
Enrolling by invitationPhase 2
Efficacy of Intravenous Oxytocin to Speed Recovery After THA
Total Hip Arthroplasty
Enrolling by invitationPhase 3
A Clinical Trial Evaluating the Efficacy and Safety of Local Infiltration of RF16001 for Injection for Analgesia After Total Hip Arthroplasty in China
Pain After Abdominal Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
KAABACHI OLFA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbal Erector Spinae Plane Block and intravenous pain killers in people with Total Hip Arthroplasty (THA), run by University Tunis El Manar at 1 site in Tunisia.
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 1 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Nov 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 Tunisia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KAABACHI OLFA, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine consumption (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2025.