- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06842342
The Analgesic Effect of Ultrasound-guided Sacral Erector Spinae, Pericapsular Nerve Block and Lumber Plexus Block for Pain Relief for Hip Surgery: Randomized Controlled Study
The aim of this study to evaluate the effect of The analgesic effect of Ultrasound-guided Sacral erector spinae, Pericapsular nerve block and Lumber Plexus block for pain relief after hip surgery.
The primary outcome will be the collective morphine consumption on the 1st day post-operatively.
Secondary end points Early postoperative pain scores including static pain and passive movement pain (at PACU, at 6 ,12,18 and 24 h after surgery) will be evaluated with visual analog scale (VAS) ranging from 0 to 10, where 0 means no pain and 10 means the worst pain Intraoperative consumption of fentanyl Intraoperative adverse reactions (hypotension, bradycardia, etc.) Complications related with anesthesia (local anesthetic systemic toxicity, pneumothorax, hematoma, etc.) Performance time of block (defined as the time from ultrasound scanning to the end of injection)
Study Overview
Status
Detailed Description
The hip joint connects the femur and pelvis and is responsible for multidimensional motion and mechanical stability [ 1 ]. Most hip pain is caused by the joint capsule [ 2 ]. Furthermore, the joint is largely controlled by the femoral, sciatic, and obturator nerves [ 3 ]. Patients may experience incomplete analgesia with techniques such as femoral nerve (FN) block alone due to the proximal locations of these nerves. Blocking the proximal innervation of all terminal branches innervating the hip joint (femoral, sciatic, obturator, etc.) causes significant weakness in the leg [ 1 ]. With the growth of the elderly population, more patients are undergoing hip surgeries. However, although methods are improving, no gold standard has been established for anesthesia or, more specifically, for analgesia in operations with high morbidity and high mortality [4]. Hip surgeries include hip arthroplasty (HA) (partial hip replacement, total hip replacement) and proximal femur operations (proximal femoral nailing) [5]. In fact, HA is one of the most successful orthopedic procedures in terms of improving patients' functional status and quality of life [ 6 ]. Appropriate pain management for surgical patients contributes to early mobilization, shorter hospital stays, reduced costs, and increased patient satisfaction.
Therefore, minimizing postoperative pain has become increasingly important for healthcare providers in recent years [ 7 ]. For this purpose, various analgesia techniques have been used. Although opioids typically provide effective pain relief, their use is limited due to serious side effects [ 8 ]. In recent years, peripheral nerve blocks (PNBs) have been used in the management of postoperative pain following hip surgery. The 2021 procedure-specific postoperative pain management (PROSPECT) guideline for total HA recommends several perioperative interventions to alleviate postoperative pain [9].
Erector spinae plane (ESP) block and pericapsular nerve group (PENG) block are the main safe and proven blocks used in hip operations [ 10 , 11 ]. PENG block is a novel regional analgesia technique that preserves motor function while reducing pain after HA. This technique involves injecting local anesthetic (LA) into the fascial plane between the psoas muscle and the superior pubic ramus [ 11 , 12 ].
Erector spinae plane block (ESPB) was first described as an interfascial plane block performed at the upper thoracic levels to alleviate neuropathic pain [13]. Later, its use has been reported in many thoracic procedures including mastectomy, video-assisted thoracoscopy (VATS), heart surgery, at lumbar levels for abdominal surgery, prostatectomy, lumbar spine surgery, total hip arthroplasty, and proximal femur surgery [14].
Sacral ESPB has been recently described. Case reports are showing that it is useful in various types of surgery. In case presentations, it has been reported as effective in providing analgesia in the posterior branches of the sacral nerves in pilonidal sinus surgery, in the treatment of radicular pain at the L5 - S1 level, after a sex reassignment operation hypospadias surgery, and its use in combination with lumbar ESPB for analgesia was reported after hip prosthesis surgery [15-20].
As a frequently used regional anesthesia technique for low limb surgery, lumbar plexus block (LPB) can provide effective analgesia and reduce opioid consumption for the patients undergoing total hip arthroplasty (THA) [20-22]. The lumbar plexus occasionally originates from T12 to L4. The three main branches of lumbar plexus that innervate the hip region, including the femoral, obturator, and lateral femoral cutaneous nerve, can be blocked with a single-level LPB at L3 [21] observed the spread of local anesthetic with MRI in the volunteers underwent LPB at L4. The injectate was mainly confined between L2 and L4 and barely diffused to T12-L1. Thus, insufficient of analgesia of the incision area may occur due to the failure block of the branches derive from T12 and L1, such as iliohypogastric and subcostal nerve [23]. As we know, the effect of regional block depends on the coverage of related nerve branches at the surgical area. Therefore, to provide a more comprehensive coverage on the wide range of lumbar plexus, multiple-level block techniques, e.g., LPB at L2 and L3, at L3 and L4, or even combined with T12 L1 paravertebral block (PVB), were applied in some studies [24-27]. However, it is conceivable that these expert techniques may require more operator expertise, consume more performance time, increase the discomfort of the patients, and have a greater risk of complications [ 28-32]. Thus, a both effective and convenient method should be investigated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tanta
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Tanta, Tanta, Egypt, 0020
- Tanta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients aged between 18 and 75 years old without cognitive dysfunction
- Body mass index (BMI) between 18.5 and 30 kg/m 2 and the weight ≥ 50 kg
- American Society of Anesthesiologists (ASA) classification I-II
Exclusion Criteria:
Refuse to general anesthesia (GA) with tracheal intubation
- Nerve block is contraindicated due to various reasons, such as open trauma, hematoma or skin infection at the blocking area, lower limb neuro-muscular disorders
- Coagulation dysfunction or anticoagulation therapy
- Known hypersensitivity or allergy to local anesthetics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group PENG
|
PENG block: All members of this group will receive PENG block in the supine position after general anesthesia, The PENG will be performed by using 40 ml mixture of, 20 mL of 0.5 bupivacaine,10 mL of 2% lidocaine, and 10 mL of normal saline.
|
|
Active Comparator: Group LPB
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LPB Group: All members of this group will receive ipsilateral lumber plexus after induction of general anesthesia.
The LPB will be performed by using 30 ml mixture of lidocaine 2% (10 ml), bupivacaine 0.25%(10 ml) and 10-mL normal saline will be injected at that point after repeated negative aspiration.
|
|
Active Comparator: Group ESB
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ESB Group: All members of this group will receive ipsilateral sacral erector spinae block after induction of general anesthesia.
The ESB will be performed by using 30 ml mixture of lidocaine 2% (10 ml), bupivacaine 0.25%(10 ml) and 10-mL normal saline will be injected at that point after repeated negative aspiration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morphine consumption over 24 hours
Time Frame: 24 hours postoperatively
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will be the collective morphine consumption on the 1st day post-operatively
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24 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score
Time Frame: During and after operation within 24 hours
|
Early postoperative pain scores including static pain and passive movement pain (at PACU, at 6 ,12,18 and 24 h after surgery) will be evaluated.
|
During and after operation within 24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36264PR977
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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Clinical Trials on Sacral Erector Block Versus Pericapsular Block Versus Lumber Plexus Block
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Menoufia UniversityCompletedPericapsular Nerve Group Block (PENG Block) | Lumbar Erector Spinae Plane BlockEgypt
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Zagazig UniversityCompletedPericapsular Nerve Group Block (PENG Block) | Lumbar Erector Spinae Plane BlockEgypt
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Ain Shams UniversityRecruitingShoulder Arthroscopy | Interscalene Brachial Plexus Block | Pericapsular Nerve BlockEgypt
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Tanta UniversityCompletedCaudal Block | Pediatrics | Sacral Erector Spinae Plane Block | Penile SurgeriesEgypt
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Fayoum University HospitalCompletedSub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle SurgeriesEgypt
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Medipol UniversityNot yet recruitingPilonidal Sinus | Sacral Erector Spinae Plane BlockTurkey (Türkiye)
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Istanbul University - CerrahpasaNot yet recruitingRegional Anaesthesia | Sacral Erector Spinae Plane Block | Pediatric Regional AnesthesiaTurkey (Türkiye)
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Ain Shams UniversityRecruitingAnlgesia for Hip Arthroscopy by Assessing Quality of Different Type of Regional Block, Femoral Nerve Block Versus Fascia Iliaca BlockEgypt
-
Ain Shams UniversityRecruitingPostoperative Pain | Interscalene Brachial Plexus Block | Pericapsular Nerve Group Block | Anterior Glenoid Nerve Block | Shoulder Arthroscopic SurgeriesEgypt
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Tanta UniversityCompletedAnalgesia | Total Hip Arthroplasty | Fascia Iliaca Block | Lumbar Plexus Block | Lumbar Erector Spinae Plane BlockEgypt
Clinical Trials on Lumber plexus block
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Cairo UniversityUnknown
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Shanghai Tong Ren HospitalShanghai 6th People's HospitalNot yet recruitingProximal Humeral Fracture | Anesthesia, Regional | Diaphragmatic ParalysisChina
-
Bozyaka Training and Research HospitalCompletedComparison of Sympathetic Blockade Duration in Brachial Plexus Blocks Performed by Different MethodsBrachial Plexus Blockade | Anesthesia, Conduction | Sympathetic BlockadeTurkey (Türkiye)
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Istanbul UniversityCompleted
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Oslo University HospitalB. Braun Melsungen AG; Philips Medical SystemsCompleted
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Ain Shams UniversityRecruitingBrachial Plexus Blocks | Regional Anesthesia BlockEgypt
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Tanta UniversityRecruitingTransversus Abdominis Plane Block | Superior Hypogastric Plexus Block | Abdominal HysterectomiesEgypt
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Sargodha Medical CollegeCompletedProcedure TimePakistan
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Shanghai Jiao Tong University Affiliated Sixth...Army Medical Center of PLACompletedHip Fracture | Nerve Block | Organ Protection | Elderly (People Aged 65 or More) | Delirium - PostoperativeChina