An interventional study of Circum-psoas Block and Sham block in Acute Pain and Opioid Use, sponsored by The Second Hospital of Shandong University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by The Second Hospital of Shandong University · Not applicable, Interventional, and Treatment
Arthroscopic hip surgery is being increasingly performed to treat both intraarticular and extraarticular hip diseases. Despite the minimally invasive approach, patients undergoing arthroscopic hip surgery still suffer severe pain due to the complex nature of hip innervation. Postoperative pain reduces patient satisfaction and delay patient recovery and discharge. The efficacy of regional anesthesia techniques in postoperative pain management have been proved in various surgeries. However, it remains controversial whether or not peripheral nerve blocks can significantly improve postoperative analgesia after hip arthroscopy.
Several studies have shown that the fascia iliac block cannot improve postoperative analgesia for hip arthroscopy because it blocks only some branches of the lumbar plexus but not the sacral plexus. Circum-Psoas Block (CPB) which has been defined in recent years is able to block the lumbar plexus nerves as well as sacral plexus such as the sciatic, superior gluteal, and inferior gluteal nerves. Therefore, the investigators predict that it can provide effective postoperative analgesia for hip arthroscopy. In this study, the researchers aim to investigate the effectiveness of CPB in hip arthroscopy.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's planned enrollment of 74 is below the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →The Second Hospital of Shandong University is the lead sponsor of 35 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
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.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Injection of 20ml 0.2% ropivacaine around the antero-lateral margin of psoas major muscle at the level of iliac crest with an in-plane approach under ultrasound guidance. Then the transducer was placed at the level of Lumbar vertebra 5 to obtain the paramedian transverse plane of the intertransverse ligament and lumbosacral ligament. An additional 20ml 0.2% ropivacaine was injected when the needle punctured the lumbosacral ligament.
Procedure: Circum-psoas Block
Perform ultrasound scanning without puncture.
Procedure: Sham block
Ultrasound-guided circum-psoas block with 40 mL of treatment drug (Ropivacaine 0.2% \[local anesthetic\]) 30 minutes prior to induction of anesthesia.
Perform ultrasound scanning without puncture.
pain severity at 6 hours postoperatively
Postoperative pain assessed with NRS pain score (NRS 0: no pain 10: pain as bad as can be) at 1, 6, 12, 24 hours postoperatively. However, to be more precise in our assessment, the effectiveness of each intervention was defined as a reduction in the pain at 6 hours postoperatively.
Time frame: 6 hours postoperatively
Postoperative opioid consumption
Cumulative 24-hr postoperative opioid consumption
Time frame: up to the first 24 hours postoperatively
Postoperative nausea and vomiting
Nausea and vomiting intensity score measured by numeric rank score (0:no nausea and no vomiting, 1: have nausea, no vomiting, 2: once vomiting, 3: two or more vomiting).
Time frame: up to the first 24 hours postoperatively
neurologic evaluation
The dermatomal coverage of sensory block was evaluated by using a cool roller at 1, 6, 24 hours post-surgery. Motor strength was assessed by the following criteria (0: none; 1: muscle flicker without movement; 2: movement, but not against gravity; 3: movement against gravity; 4: movement against some resistance; 5: normal strength).
Time frame: 1, 6, 24 hours postoperatively
Patient satisfaction
Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Time frame: at the end of 24 hours postoperatively
No study locations are listed for this record.
Plan to share: No
Start is estimated for Dec 2024; primary completion for Dec 2025, 12 months later.
Of 424 non-industry interventional studies with no phase under Acute Pain, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 12 months is close to that.
Counting every sponsor, half of 430 studies reached it within 11 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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The Second Hospital of Shandong University