Postoperative PainNCT04003909
Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries
A study testing ultrasound-guided Erector spinae plane block and subarachonoid block in people with Postoperative Pain, run by Bassant M. Abdelhamid at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ultrasound-guided Erector spinae plane block and subarachonoid block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2019to 6 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- ultrasound-guided Erector spinae plane block, subarachonoid block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided Erector spinae plane blockProcedure or surgery
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.
subarachonoid blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ESP group | Experimental | patients will have ultrasound guided ESP block before spinal anesthesia. Receives: Procedure: ultrasound-guided Erector spinae plane block; Procedure: subarachonoid block |
| Control group | Experimental | patients will have spinal Anesthesia without ESP block Receives: Procedure: subarachonoid block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Total morphine consumption in rescue boluses during 1st 24 hrs postoperatively.
Measured: 24 hours postoperative
Secondary outcomes (3)
Visual analogue scale
Visual analogue scale at the following intervals:30 minutes,2,4, 6, 12, and 24 hours postoperative.
Measured: 30 minutes,2,4, 6, 12, and 24 hours postoperative.
Duration of analgesia
defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic in the form of iv morphine
Measured: 24 hours postoperative
Incidence of complications
Nerve injury, Hematoma formation, LA toxicity, Intravascular injection.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start5 Jul 2019
- Primary completion5 Oct 2019
- Study completion6 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bassant M. Abdelhamid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- Ashraf Rady, M.D., Principal investigator, Cairo UniversityAmr abdelnasser, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003909
- Sponsor's protocol ID
- N-147-2018
- Status last verified
- Nov 2019
- First submitted
- 26 Jun 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
PubMed 29522966Ueshima H, Otake H. RETRACTED: Clinical experiences of ultrasound-guided erector spinae plane block for thoracic vertebra surgery. J Clin Anesth. 2017 May;38:137. doi: 10.1016/j.jclinane.2016.12.028. Epub 2017 Feb 17. No abstract available.
PubMed 28372654Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.
PubMed 28203765Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
PubMed 29913392
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries
- ClinicalTrials.gov ID
- NCT04003909
- Acronym / sponsor ID
- N-147-2018
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bassant M. AbdelhamidUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 6 Nov 2019 (actual)
- First posted
- 1 Jul 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP group | Experimental | Procedure: ultrasound-guided Erector spinae plane block, Procedure: subarachonoid blockpatients will have ultrasound guided ESP block before spinal anesthesia. |
| Control group | Experimental | Procedure: subarachonoid blockpatients will have spinal Anesthesia without ESP block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| ultrasound-guided Erector spinae plane blockThe 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 or surgery | ESP group |
| subarachonoid blockLocal 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. | Procedure or surgery | Control group, ESP group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperative
Total morphine consumption in rescue boluses during 1st 24 hrs postoperatively.
3 secondary outcomes
Visual analogue scale
Time frame: 30 minutes,2,4, 6, 12, and 24 hours postoperative.
Duration of analgesia
Time frame: 24 hours postoperative
Incidence of complications
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Background: PubMed 29522966Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
- Background: PubMed 28372654Ueshima H, Otake H. RETRACTED: Clinical experiences of ultrasound-guided erector spinae plane block for thoracic vertebra surgery. J Clin Anesth. 2017 May;38:137. doi: 10.1016/j.jclinane.2016.12.028. Epub 2017 Feb 17. No abstract available.
- Background: PubMed 28203765Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.
- Background: PubMed 29913392Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ashraf Rady, M.D. principal investigator
Cairo University
Amr abdelnasser study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided Erector spinae plane block and subarachonoid block in people with Postoperative Pain, run by Bassant M. Abdelhamid at 1 site in Egypt.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 7 Nov 2019. 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04003909, which also lists 4 linked publications.
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 7 Nov 2019.