Hip ArthropathyNCT03904095
Comparison Between the Analgesic Efficacy of Erector Spinae Plane Block and Psoas Compartment Block in Hip Surgery
A study testing Psoas Compartment Block Group (GROUP I) and Erector Spinae Plane block ( Group II) in people with Hip Arthropathy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the ability of Erector spina Plane block and Psoas compartment block to decrease postoperative pain and analgesia requirements in patients undergoing hip surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hip Arthropathy
- What is being tested?
- Psoas Compartment Block Group (GROUP I) and Erector Spinae Plane block ( Group II)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Feb 2022
- 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
- ASA (American Society of Anesthesiologists) I- ASA II Patients
- -
Who cannot join
- history of allergy to the study medication
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the ability of Erector spina Plane block and Psoas compartment block to decrease postoperative pain and analgesia requirements in patients undergoing hip surgery.
Read the detailed description
Erector spina Plane block or Psoas compartment block will performed with guided ultrasound at L4 Transverse process level would lead to adequate postoperative analgesia ,in total hip arthroplasty surgeries.
- Conditions
- Hip Arthropathy
- Being tested
- Psoas Compartment Block Group (GROUP I), Erector Spinae Plane block ( Group II), Control Group (GROUP III)
- Keywords
- Erector spinae block, hip arthroplasty, postoperative analgesia, psoas compartment block, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psoas Compartment Block Group (GROUP I)Procedure or surgery
Psoas Compartment Block will perform preoperative to all patients in Group I. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
Erector Spinae Plane block ( Group II)Procedure or surgery
ESP Block will perform preoperative to all patients in ESP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
Control Group (GROUP III)Procedure or surgery
Control group will receive no intervention. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Psoas compartment block group (PCB) | Active comparator | Single- shot ultrasound (Esaote Mylab30) guided PCB with 15 ml 0.25% bupivacain ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the PCB group (Group I). Receives: Procedure: Psoas Compartment Block Group (GROUP I) |
| Erector spinae plane block group (ESP) | Active comparator | Single- shot ultrasound (Esaote Mylab30) guided ESP block with 15 ml 0.25% ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the ESP group (Group II). Receives: Procedure: Erector Spinae Plane block ( Group II) |
| The Control group | Placebo comparator | The Control group receive no intervention ( Group III). Receives: Procedure: Control Group (GROUP III) |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 6 mg 1 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
Measured: 24 hours after surgery
Verbal analog Pain Scores on rest and movement
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
Measured: 24 hours after surgery
Secondary outcomes (1)
incidences of adverse effects (like nausea and vomiting)
incidences of nausea and vomiting during the 24 hours postoperative period will recorded at 6 time intervals ( 2, 4, 6, 12, 24 hours).
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Feb 2019
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Model description
- Patients randomly allocated to three treatment groups: , The psoas compartment block (Group I) the ESP block group (Group II) and the control group (Group III). Blocks performed after general anesthesia induction with the Ultrasound while patients lying on surgical type at the top.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Seçkin Pehlivan, TC Erciyes University
- Investigators
- Sibel Pehlivan, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904095
- Sponsor's protocol ID
- 2019/98
- Status last verified
- Apr 2019
- First submitted
- 28 Mar 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Touray ST, de Leeuw MA, Zuurmond WW, Perez RS. Psoas compartment block for lower extremity surgery: a meta-analysis. Br J Anaesth. 2008 Dec;101(6):750-60. doi: 10.1093/bja/aen298. Epub 2008 Oct 22.
PubMed 18945717Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
PubMed 30292068Tulgar S, Ermis MN, Ozer Z. Combination of lumbar erector spinae plane block and transmuscular quadratus lumborum block for surgical anaesthesia in hemiarthroplasty for femoral neck fracture. Indian J Anaesth. 2018 Oct;62(10):802-805. doi: 10.4103/ija.IJA_230_18.
PubMed 30443064
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Analgesic Efficacy of Erector Spinae Plane Block and Psoas Compartment Block in Hip Surgery
- ClinicalTrials.gov ID
- NCT03904095
- Acronym / sponsor ID
- 2019/98
- Conditions
- Hip Arthropathy
- Keywords
- Erector spinae block, hip arthroplasty, postoperative analgesia, psoas compartment block, ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 4 Apr 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.
To evaluate the ability of Erector spina Plane block and Psoas compartment block to decrease postoperative pain and analgesia requirements in patients undergoing hip surgery.
Detailed description
Erector spina Plane block or Psoas compartment block will performed with guided ultrasound at L4 Transverse process level would lead to adequate postoperative analgesia ,in total hip arthroplasty surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Patients randomly allocated to three treatment groups: , The psoas compartment block (Group I) the ESP block group (Group II) and the control group (Group III). Blocks performed after general anesthesia induction with the Ultrasound while patients lying on surgical type at the top.
| Arm | Type | Receives |
|---|---|---|
| Psoas compartment block group (PCB) | Active comparator | Procedure: Psoas Compartment Block Group (GROUP I)Single- shot ultrasound (Esaote Mylab30) guided PCB with 15 ml 0.25% bupivacain ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the PCB group (Group I). |
| Erector spinae plane block group (ESP) | Active comparator | Procedure: Erector Spinae Plane block ( Group II)Single- shot ultrasound (Esaote Mylab30) guided ESP block with 15 ml 0.25% ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the ESP group (Group II). |
| The Control group | Placebo comparator | Procedure: Control Group (GROUP III)The Control group receive no intervention ( Group III). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA (American Society of Anesthesiologists) I- ASA II Patients
- -
Key exclusion criteria (2 listed)
- history of allergy to the study medication
- refusal to participate
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 |
|---|---|---|
| Psoas Compartment Block Group (GROUP I)Psoas Compartment Block will perform preoperative to all patients in Group I. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia. | Procedure or surgery | Psoas compartment block group (PCB) |
| Erector Spinae Plane block ( Group II)ESP Block will perform preoperative to all patients in ESP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia. | Procedure or surgery | Erector spinae plane block group (ESP) |
| Control Group (GROUP III)Control group will receive no intervention. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia. | Procedure or surgery | The Control group |
Primary outcome
opioid consumption
Time frame: 24 hours after surgery
In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 6 mg 1 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
Verbal analog Pain Scores on rest and movement
Time frame: 24 hours after surgery
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
1 secondary outcome
incidences of adverse effects (like nausea and vomiting)
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Results publication: PubMed 18945717Touray ST, de Leeuw MA, Zuurmond WW, Perez RS. Psoas compartment block for lower extremity surgery: a meta-analysis. Br J Anaesth. 2008 Dec;101(6):750-60. doi: 10.1093/bja/aen298. Epub 2008 Oct 22.
- Results publication: PubMed 30292068Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
- Results publication: PubMed 30443064Tulgar S, Ermis MN, Ozer Z. Combination of lumbar erector spinae plane block and transmuscular quadratus lumborum block for surgical anaesthesia in hemiarthroplasty for femoral neck fracture. Indian J Anaesth. 2018 Oct;62(10):802-805. doi: 10.4103/ija.IJA_230_18.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
Related trials for Hip Arthropathy
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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.
Sibel Pehlivan study director
TC Erciyes 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 Psoas Compartment Block Group (GROUP I) and Erector Spinae Plane block ( Group II) in people with Hip Arthropathy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Apr 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
opioid consumption (time frame: 24 hours after surgery). The study lists 2 primary outcomes in all. 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 NCT03904095, which also lists 3 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 8 Apr 2019.