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出境医 / 临床实验 / Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries
Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries
Study Description
Brief Summary:
ESP block advantages include its simplicity, easy identifiable ultrasonographic landmarks and low risk for serious complications as injection is into tissue plane that is distant from pleura, major blood vessels and discrete nerves. Coupled with the fact that the erector spinae muscle and ESP extend down to the lumbar spine, ESP block was hypothesized to be performed at the level of L4. In a recent case report, ultrasound guided ESP block was successfully performed at L4 transverse process level for postoperative analgesia after total hip arthroplasty. However, confirmation of the efficacy of ESP block in hip replacement surgeries needed more investigation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postoperative Pain | Procedure: ultrasound-guided Erector spinae plane block Procedure: subarachonoid block | Not Applicable |
Detailed Description:
This study will be performed in Cairo university hospital. Thirty adult patients of both sexes scheduled for hip replacement surgery under spinal anesthesia will be enrolled in the study.
All patients meeting the inclusion criteria will be randomly assigned to one of 2 groups, 15 per group:
Group E, ESP group (n=15): prior to surgical incision, patients will have ultrasound guided ESP block before spinal anesthesia.
Group C, Control group (n=15): prior to surgical incision, patients will have spinal Anesthesia without ESP block .
Patients will be randomly allocated by a computer-generated table into one of the study groups, the randomization sequence will be concealed in sealed opaque envelopes.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effectiveness of Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries |
| Actual Study Start Date : | July 5, 2019 |
| Actual Primary Completion Date : | October 5, 2019 |
| Actual Study Completion Date : | November 6, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: ESP group
patients will have ultrasound guided ESP block before spinal anesthesia.
|
Procedure: ultrasound-guided Erector spinae plane block
The patients will be in lateral position. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. Local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle will be inserted inplane to the ultrasound beam in a cranial-to-caudal direction until contact made with the L4 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5-1ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total volume of 20ml bupivicaine 0.25% and 20 ml xylocaine 1% will be injected into the ESP on the affected side.
Procedure: subarachonoid block Local anesthesia 2ml of lidocaine 2% will be applied intradermally to the needle entrance point. A 22-G block needle will be inserted, free cerebrospinal fluid flow will be observed and 20mg of hyperbaric bupivacaine 0.5% and 10μg of fentanyl will be injected for 30 seconds.
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Experimental: Control group
patients will have spinal Anesthesia without ESP block
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Procedure: subarachonoid block
Local anesthesia 2ml of lidocaine 2% will be applied intradermally to the needle entrance point. A 22-G block needle will be inserted, free cerebrospinal fluid flow will be observed and 20mg of hyperbaric bupivacaine 0.5% and 10μg of fentanyl will be injected for 30 seconds.
|
Outcome Measures
Primary Outcome Measures :
- Total morphine consumption [ Time Frame: 24 hours postoperative ]Total morphine consumption in rescue boluses during 1st 24 hrs postoperatively.
Secondary Outcome Measures :
- Visual analogue scale [ Time Frame: 30 minutes,2,4, 6, 12, and 24 hours postoperative. ]Visual analogue scale at the following intervals:30 minutes,2,4, 6, 12, and 24 hours postoperative.
- Duration of analgesia [ Time Frame: 24 hours postoperative ]defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic in the form of iv morphine
- Incidence of complications [ Time Frame: 24 hours ]Nerve injury, Hematoma formation, LA toxicity, Intravascular injection.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients aged from 40 to 65 years old
- Both sexes.
- ASA I-II.
- Undergo hip replacement surgery.
- Body mass index (BMI) from 18 to 35 kg/m2.
Exclusion Criteria:
- Patient refusal.
- Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, etc. )
- BMI > 35.
- Known allergy to local anesthetics.
- ASA III-IV.
- Patients with difficulty in evaluating their level of pain.
Contacts and Locations
Locations
| Egypt | |
| Anesthesia Department | |
| Cairo, Egypt, 1772 | |
Sponsors and Collaborators
Bassant M. Abdelhamid
Investigators
| Principal Investigator: | Ashraf Rady, M.D. | Cairo University | |
| Study Director: | Amr abdelnasser | Cairo University |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 26, 2019 | ||||||
| First Posted Date ICMJE | July 1, 2019 | ||||||
| Last Update Posted Date | November 7, 2019 | ||||||
| Actual Study Start Date ICMJE | July 5, 2019 | ||||||
| Actual Primary Completion Date | October 5, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Total morphine consumption [ Time Frame: 24 hours postoperative ] Total morphine consumption in rescue boluses during 1st 24 hrs postoperatively.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries | ||||||
| Official Title ICMJE | Effectiveness of Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries | ||||||
| Brief Summary | ESP block advantages include its simplicity, easy identifiable ultrasonographic landmarks and low risk for serious complications as injection is into tissue plane that is distant from pleura, major blood vessels and discrete nerves. Coupled with the fact that the erector spinae muscle and ESP extend down to the lumbar spine, ESP block was hypothesized to be performed at the level of L4. In a recent case report, ultrasound guided ESP block was successfully performed at L4 transverse process level for postoperative analgesia after total hip arthroplasty. However, confirmation of the efficacy of ESP block in hip replacement surgeries needed more investigation. | ||||||
| Detailed Description |
This study will be performed in Cairo university hospital. Thirty adult patients of both sexes scheduled for hip replacement surgery under spinal anesthesia will be enrolled in the study. All patients meeting the inclusion criteria will be randomly assigned to one of 2 groups, 15 per group: Group E, ESP group (n=15): prior to surgical incision, patients will have ultrasound guided ESP block before spinal anesthesia. Group C, Control group (n=15): prior to surgical incision, patients will have spinal Anesthesia without ESP block . Patients will be randomly allocated by a computer-generated table into one of the study groups, the randomization sequence will be concealed in sealed opaque envelopes. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Postoperative Pain | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
30 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | November 6, 2019 | ||||||
| Actual Primary Completion Date | October 5, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Egypt | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04003909 | ||||||
| Other Study ID Numbers ICMJE | N-147-2018 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Bassant M. Abdelhamid, Cairo University | ||||||
| Study Sponsor ICMJE | Bassant M. Abdelhamid | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Cairo University | ||||||
| Verification Date | November 2019 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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