Hip FracturesNCT05400148
Dose and Concentration Relationship for PENG Block in Hip Surgery
An observational study of Hip Fractures and Post Operative Pain, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
A number of peripheral nerve blocks are routinely performed in patients who will undergo orthopedic hip surgery for pain relief. Proximal extensor group nerve (PENG) block is one such field block which is used for this purpose and could be performed both before and after the operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Post Operative Pain
- What is being tested?
- Bupivacaine Hydrochloride
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 5 May 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected consecutively from those who are admitted to a tertiary care center with a diagnosis of hip fracture and scheduled for a hip surgery in a tertiary care center, until the required sample size is achieved.
Who may be able to join
- Patients over the age of 18 who consent to participate and;
- Patients who are scheduled for hip surgery under spinal anaesthesia,
- Patients who have no neurocognitive disorders that impair cooperation and communication (e.g Alzheimer's disease, Parkinson's disease, senile dementia),
- Patients who have no local anaesthetic allergies,
- Patients to whom an analgesic PENG block was administered preoperatively to facilitate sitting position during spinal anaesthesia will be included.
Who cannot join
- Patients under the age of 18,
- Patients who decline to participate,
- Patients who are scheduled for hip surgery under general anaesthesia
- Patients who have neurocognitive disorders
- Patients who have local anaesthetic allergies
- Patients to whom an analgesic PENG block was NOT administered preoperatively to facilitate sitting position during spinal anaesthesia will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, 34384
About this study
Official title: Dose and Concentration Relationship of Bupivacaine for Pericapsular Nerve Group Block in Hip Surgery
A number of peripheral nerve blocks are routinely performed in patients who will undergo orthopedic hip surgery for pain relief. Proximal extensor group nerve (PENG) block is one such field block which is used for this purpose and could be performed both before and after the operation. When used before surgery, PENG block is reported to be beneficial in alleviating pain during positioning for spinal anesthesia. Furthermore, some studies suggest a high volume block may increase the analgesic effect of the block. In this perspective, this study aims to observe the effects of different volumes of local anesthetic (bupivacaine) at the same dose used for PENG block in hip fracture positioning for spinal anesthesia.
The investigator hypothesizes that a high volume (>20ml) PENG block will reduce pain during positioning compared to a low volume PENG block.
Read the detailed description
This prospective observational study will be conducted between 04.07.2022-04.01.2023 in the orthopedic operating rooms of T.C. Ministry of Health University of Health Sciences Prof. Dr. Cemil Taşçıoğlu City Hospital. Patients over the age of 18 who are scheduled for hip fracture under spinal anesthesia meeting the inclusion criteria and who agree to participate in the study by signing a consent form will be included. Patients will be surveyed about the amount of pain they suffer with numerical rating scale (NRS) four times; firstly, 15 minutes after the block at rest, then, a second time with a 10 degree hip flexion, after that a third time when patient is given sitting position for spinal anesthesia, and lastly, 24 hours after the surgery. Age, height, weight, gender, co-morbidities, American Society of Anesthesiologists physical condition (ASA) scores, time of block administration, whether an intraoperative complication developed (hypotension, tachycardia, bradycardia, inotropic need, desaturation), local anesthetic (bupivacaine) volume used for PENG block will be recorded from the anesthesia charts. Twenty-four hours after the surgery patients will be questioned for nausea, vomiting and urinary retention. At this point the 4 A's test (4AT) will be performed to detect any presence of delirium. Postoperative iv analgesic treatments and mobilization times(if mobilized) of the patients will be recorded from patient charts. Resulting data for low volume (less than or equal to 20ml) and high volume PENG blocks will be compared.
It is expected that a total of 112 patients will be recruited for this study. A power analysis revealed that it is necessary to recruit at least 102 patients, when effect size d is assumed to be 0.5 ( for medium difference) for a 0.05 alpha error with a %80 power. Taking in account a 10% follow-up loss we planned to recruit 112 patients.
- Conditions
- Hip Fractures, Post Operative Pain
- Being tested
- Bupivacaine Hydrochloride
- Keywords
- hip fracture, peripheral nerve blocks, postoperative pain, bupivacaine volume
- Medical subject headings
- Hip Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Also called PENG block
Patients who were administered an analgesic PENG block with a dose of 2.5mg/kg with either lov (<20ml) or high volume (>20ml)
| Study group | Role | What they receive |
|---|---|---|
| low volume | This cohort will include the patients to whom an analgesic PENG block was administered with a bupivacaine solution volume of up to 20 ml in a dose of 2.5mg/kg-1. This cohort is anticipated to have 56 participants. Receives: Drug: Bupivacaine Hydrochloride | |
| high volume | This cohort will include the patients to whom an analgesic PENG block was administered with a bupivacaine solution volume more than 20 ml in a dose of 2.5mg/kg-1. This cohort is anticipated to have 56 participants. Receives: Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sitting pain
Pain score according to numerical rating scale when patient is brought to sitting position for spinal anesthesia. Numeric rating scale is a patient's self reported pain score between a minimum of "0" and a maximum of "10". Higher numbers indicate worse pain. A score of "0" means that patient suffers no pain at all while a score of "10" means they suffer the worst pain possible.
Measured: 30 minutes after PENG block is performed
Secondary outcomes (5)
Block pain at rest
Pain score at rest according to numerical rating scale after PENG blok is performed. Numeric rating scale is a patient's self reported pain score between a minimum of "0" and a maximum of "10". Higher numbers indicate worse pain. A score of "0" means that patient suffers no pain at all while a score of "10" means they suffer the worst pain possible.
Measured: 15 minutes after PENG block is performed
Block pain with movement
Pain score with 10 degree flexion according to numerical rating scale after PENG. Numeric rating scale is a patient's self reported pain score between a minimum of "0" and a maximum of "10". Higher numbers indicate worse pain. A score of "0" means that patient suffers no pain at all while a score of "10" means they suffer the worst pain possible.
Measured: 15 minutes after PENG block is performed
Postoperative pain
Pain score at rest according to numerical rating scale postoperatively. Numeric rating scale is a patient's self reported pain score between a minimum of "0" and a maximum of "10". Numbers increase with increasing pain and a score of "0" means that patient suffers no pain at all and "10" means they suffer the worst pain possible.
Measured: Postoperative 24th hour
Breakthrough analgesic use
Existence and amount of breakthrough analgesics used
Measured: Postoperative 24th hour
Delirium
Existence of delirium according to 4AT score
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Nov 2022
- Primary completion1 May 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Okur, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Onur OKUR, Principal investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400148
- Sponsor's protocol ID
- 108
- Status last verified
- Feb 2024
- First submitted
- 27 May 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose and Concentration Relationship of Bupivacaine for Pericapsular Nerve Group Block in Hip Surgery
- ClinicalTrials.gov ID
- NCT05400148
- Acronym / sponsor ID
- 108
- Conditions
- Hip Fractures, Post Operative Pain
- Keywords
- hip fracture, peripheral nerve blocks, postoperative pain, bupivacaine volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 1 Jun 2022 (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.
A number of peripheral nerve blocks are routinely performed in patients who will undergo orthopedic hip surgery for pain relief. Proximal extensor group nerve (PENG) block is one such field block which is used for this purpose and could be performed both before and after the operation. When used before surgery, PENG block is reported to be beneficial in alleviating pain during positioning for spinal anesthesia. Furthermore, some studies suggest a high volume block may increase the analgesic effect of the block. In this perspective, this study aims to observe the effects of different volumes of local anesthetic (bupivacaine) at the same dose used for PENG block in hip fracture positioning for spinal anesthesia.
The investigator hypothesizes that a high volume (>20ml) PENG block will reduce pain during positioning compared to a low volume PENG block.
Detailed description
This prospective observational study will be conducted between 04.07.2022-04.01.2023 in the orthopedic operating rooms of T.C. Ministry of Health University of Health Sciences Prof. Dr. Cemil Taşçıoğlu City Hospital. Patients over the age of 18 who are scheduled for hip fracture under spinal anesthesia meeting the inclusion criteria and who agree to participate in the study by signing a consent form will be included. Patients will be surveyed about the amount of pain they suffer with numerical rating scale (NRS) four times; firstly, 15 minutes after the block at rest, then, a second time with a 10 degree hip flexion, after that a third time when patient is given sitting position for spinal anesthesia, and lastly, 24 hours after the surgery. Age, height, weight, gender, co-morbidities, American Society of Anesthesiologists physical condition (ASA) scores, time of block administration, whether an intraoperative complication developed (hypotension, tachycardia, bradycardia, inotropic need, desaturation), local anesthetic (bupivacaine) volume used for PENG block will be recorded from the anesthesia charts. Twenty-four hours after the surgery patients will be questioned for nausea, vomiting and urinary retention. At this point the 4 A's test (4AT) will be performed to detect any presence of delirium. Postoperative iv analgesic treatments and mobilization times(if mobilized) of the patients will be recorded from patient charts. Resulting data for low volume (less than or equal to 20ml) and high volume PENG blocks will be compared.
It is expected that a total of 112 patients will be recruited for this study. A power analysis revealed that it is necessary to recruit at least 102 patients, when effect size d is assumed to be 0.5 ( for medium difference) for a 0.05 alpha error with a %80 power. Taking in account a 10% follow-up loss we planned to recruit 112 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low volume | – | Drug: Bupivacaine HydrochlorideThis cohort will include the patients to whom an analgesic PENG block was administered with a bupivacaine solution volume of up to 20 ml in a dose of 2.5mg/kg-1. This cohort is anticipated to have 56 participants. |
| high volume | – | Drug: Bupivacaine HydrochlorideThis cohort will include the patients to whom an analgesic PENG block was administered with a bupivacaine solution volume more than 20 ml in a dose of 2.5mg/kg-1. This cohort is anticipated to have 56 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected consecutively from those who are admitted to a tertiary care center with a diagnosis of hip fracture and scheduled for a hip surgery in a tertiary care center, until the required sample size is achieved.
Key inclusion criteria (5 listed)
- Patients over the age of 18 who consent to participate and;
- Patients who are scheduled for hip surgery under spinal anaesthesia,
- Patients who have no neurocognitive disorders that impair cooperation and communication (e.g Alzheimer's disease, Parkinson's disease, senile dementia),
- Patients who have no local anaesthetic allergies,
- Patients to whom an analgesic PENG block was administered preoperatively to facilitate sitting position during spinal anaesthesia will be included.
Key exclusion criteria (6 listed)
- Patients under the age of 18,
- Patients who decline to participate,
- Patients who are scheduled for hip surgery under general anaesthesia
- Patients who have neurocognitive disorders
- Patients who have local anaesthetic allergies
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 |
|---|---|---|
| Bupivacaine HydrochlorideAlso: PENG blockPatients who were administered an analgesic PENG block with a dose of 2.5mg/kg with either lov (<20ml) or high volume (>20ml) | Drug | high volume, low volume |
Primary outcome
Sitting pain
Time frame: 30 minutes after PENG block is performed
Pain score according to numerical rating scale when patient is brought to sitting position for spinal anesthesia. Numeric rating scale is a patient's self reported pain score between a minimum of "0" and a maximum of "10". Higher numbers indicate worse pain. A score of "0" means that patient suffers no pain at all while a score of "10" means they suffer the worst pain possible.
5 secondary outcomes
Block pain at rest
Time frame: 15 minutes after PENG block is performed
Block pain with movement
Time frame: 15 minutes after PENG block is performed
Postoperative pain
Time frame: Postoperative 24th hour
Breakthrough analgesic use
Time frame: Postoperative 24th hour
Delirium
Time frame: Postoperative 24th hour
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 Feb 2024.
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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.
Onur OKUR principal investigator
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Post Operative Pain, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 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 Feb 2024. 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. 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?
Sitting pain (time frame: 30 minutes after PENG block is performed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2024.