An interventional study of Lumbal Erector Spinae Plane Block and intravenous pain killers in Total Hip Arthroplasty (THA), sponsored by University Tunis El Manar. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by University Tunis El Manar · Not applicable, Interventional, and Treatment
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.
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
Post-operative analgesia will include:
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.
University Tunis El Manar is the lead sponsor of 74 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
or refusal to regional anesthesia
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Procedure: Lumbal Erector Spinae Plane Block
intravenous pain killers
Procedure: intravenous pain killers
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 killers
morphine consumption
total morphine dose
Time frame: Day 1
pain scores
numerical pain rating scale \[1 to 10 worse outcome\]
Time frame: 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
Time frame: end of surgery
pain on sitting position
numerical pain rating scale \[1 to 10 worse outcome\]
Time frame: Day 1
QR 9 score
quality of recovery score \[0 to 18 best outcome\]
Time frame: Day 2
ROM
Range of mouvement \[0° to 90°best outcome\]
Time frame: Day 1
pain during walk
numerical pain rating scale \[1 to 10 worse outcome\]
Time frame: Day 7
Plan to share: No
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University Tunis El Manar