Postoperative PainNCT07075432
Preoperative and Postoperative Comparison of Two Nerve Blocks in Intertrochanteric Fracture Surgery
An observational study of Postoperative Pain and Fracture Femur, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
Patients with intertrochanteric femur fractures experience significant perioperative and postoperative pain. Perioperative pain can complicate and prolong the anesthesia process for patients undergoing spinal anesthesia, leading to complications in the procedure. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Postoperative Pain, Fracture Femur
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2025to 19 Nov 2025
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It was calculated that a minimum of 64 patients should be included in the study. Patients between the ages of 30 and 85 who are scheduled for intertrochanteric femur fracture surgery by the orthopedics and traumatology clinic will be included in the study.
Who may be able to join
- Patients scheduled for elective intertrochanteric femur fracture surgery
- Patients with ASA I, II, or III risk scores
- Patients aged 30-85
Who cannot join
- Patients with an ASA risk score of IV or higher
- Patients undergoing emergency surgery
- Patients who refuse to participate in the study or wish to withdraw afterward
- Patients with cognitive dysfunction such as Alzheimer's, dementia, or delirium
- Patients with a history of local anesthetic drug toxicity
- Patients with an infection in the area where the block will be performed
Show all 9Show fewer
- Patients with bleeding diatheses
- Patients undergoing additional surgery or additional anesthetic procedures (general anesthesia)
- Patients with a history of chronic opioid use and those receiving neuropathic pain treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzincan Üniversitesi, Erzincan, Merkez 24100
Erzincan, Merkez, 24100
About this study
Official title: Comparison of the Effects of Pericapsular Nerve Block and Anterior Quadratus Lumborum Block on Spinal Anesthesia Position Pain and Postoperative Analgesia in Patients Undergoing Surgery Due to Intertrochanteric Femur Fracture
Patients with intertrochanteric femur fractures experience significant perioperative and postoperative pain. Perioperative pain can complicate and prolong the anesthesia process for patients undergoing spinal anesthesia, leading to complications in the procedure. Postoperative pain, in turn, prolongs hospital stays, delays recovery, and can lead to chronic postoperative pain due to high-dose opioid use for pain control.
The aim of this single-center, prospective, observational study is to compare the effects of pericapsular nerve block and anterior quadratus lumborum block on spinal anesthesia positioning pain and postoperative analgesia in patients undergoing surgery for intertrochanteric femur fractures. Our study distinguishes itself by providing scientific guidance, as there are no studies in the literature comparing the effects of these two blocks on spinal anesthesia positioning pain, spinal anesthesia success, and postoperative analgesia.
Read the detailed description
A prospective observational study was planned to be conducted in the operating room of Erzincan Mengücek Gazi Training and Research Hospital. The study will be initiated after approval from the university ethics committee and written informed consent from the patients. A minimum of 64 patients aged 30-85 with elective intertrochanteric femur fractures scheduled for surgery under spinal anesthesia by the orthopedic clinic and ASA I, II, or III will be included in the study. Patients with an ASA risk score of IV or higher, those undergoing emergency surgery, those who refused the study or wished to withdraw later, those with Alzheimer's dementia delirium-like cognitive dysfunction, those with a history of local anesthetic drug toxicity, those with an infection at the block site, those with bleeding diatheses, those undergoing additional surgery or additional anesthetic procedures (general anesthesia), those with a history of chronic opioid use, and those receiving neuropathic pain medication will be excluded from the study. The study will be conducted over a 6-month period from May 19, 2025, to November 19, 2025. All patients will be informed about the study protocol and the procedures to be performed the day before surgery, and written informed consent will be obtained. Patients who are admitted to the preoperative preparation room in the operating room and who undergo routine preoperative monitoring and receive routine ultrasound-guided pericapsular nerve block (PENG) will be included in Group P, and those who undergo routine ultrasound-guided anterior quadratus lumborum block (QLB-3) will be included in Group Q. As is the routine perioperative approach, nasal oxygen will be administered at 2 L/min.
Patients will be transferred to the operating table for spinal anesthesia 30 minutes after the block. Hemodynamic data (SpO2, blood pressure, and pulse rate) will be recorded as is the routine preoperative and intraoperative process. During this process, the patient's resting pain before the block, dynamic pain before the block (leg pain at 15 degrees of elevation), resting pain at 30 minutes after the block, dynamic pain at 30 minutes after the block (leg pain at 15 degrees of elevation), and pain in the given position during spinal anesthesia will be recorded using a numerical rating scale (NRS). (The Numerical Rating Scale (NRS) is a pain score used to rate pain. During this score measurement, patients are asked to verbally state a number that corresponds to their pain, place a check mark on the number indicating their pain, or point to the number. The scale ranges from 0 to 10. 0 indicates no pain, while 10 represents the worst possible pain. Additionally, the anesthesiologist's block application times and whether spinal anesthesia was successful on the first attempt will be recorded. Patients in each group will be included in the group based on their demographic characteristics. After the procedure, patients will be admitted to the postoperative care unit as usual. Patients with an Aldrete score >9 will be transferred to the ward (The Aldrete Scoring System is a scoring system that reflects physiological recovery after anesthesia. This system examines five parameters: muscle activity, respiration, circulation, consciousness, and oxygen saturation. Each parameter is assigned a score of 0, 1, or 2, with a maximum total score of 10).
Patients' rest pain will be assessed and recorded using a numerical rating scale (NRS) at 1 hour, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively. All patients will be routinely administered 50 mg dexketoprofen intravenously three times daily for postoperative analgesia. Additionally, as is routinely done for postoperative pain management in our hospital's orthopedic department, 1 mg/kg tramadol will be administered intravenously as rescue analgesia if the patient's Numerical Rating Scale (NRS) score is 4 or higher (Rescue analgesia is an additional analgesic procedure performed when pain persists despite routine analgesic treatment). Tramadol dosing intervals will be planned to be no less than 6 hours, and the maximum daily tramadol dose will not exceed 400 mg. The total number of analgesic medications (NSAIDs or opioids) used in addition to the nerve block administered for pain control within 24 hours postoperatively will be recorded. For postoperative patient monitoring, patients will be evaluated by a physician who is unaware of the type of block administered.
- Conditions
- Postoperative Pain, Fracture Femur
- Keywords
- pericapsular nerve block, quadratus lumborum block, anterior, Pain, Postoperative, Fracture, intertrochanteric
- Medical subject headings
- Pain, Postoperative, Femoral Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Grup P-Pericapsular Nerve Block | Among the patients taken to the preoperative preparation room in the operating room, those who received routine ultrasound-guided pericapsular nerve block (PENG) following routine preoperative monitoring will be added to Group P. Pain measurement will be evaluated according to the NRS scale. | |
| Grup Q-Anterior Quadratus Lumborum Block | Among the patients taken to the preoperative preparation room in the operating room, those who underwent routine ultrasound-guided anterior quadratus lumborum (QLB-3) following routine preoperative monitoring will be added to Group Q. Pain measurement will be evaluated according to the NRS scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
The numerical rating scale (NRS) is a pain score used to rate pain. Patients are asked to verbally indicate a number that matches their pain, place a check mark on the number indicating their pain, or point to the number. The scale ranges from 0 to 10. 0 indicates no pain, while 10 represents the worst possible pain.
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 posted20 Jul 2025
- Study start19 May 2025
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİDEM ONK, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075432
- Sponsor's protocol ID
- ErzincanU-ANESTEZİ-DO-02
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Pericapsular Nerve Block and Anterior Quadratus Lumborum Block on Spinal Anesthesia Position Pain and Postoperative Analgesia in Patients Undergoing Surgery Due to Intertrochanteric Femur Fracture
- ClinicalTrials.gov ID
- NCT07075432
- Acronym / sponsor ID
- ErzincanU-ANESTEZİ-DO-02
- Conditions
- Postoperative Pain, Fracture Femur
- Keywords
- pericapsular nerve block, quadratus lumborum block, anterior, Pain, Postoperative, Fracture, intertrochanteric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 20 Jul 2025 (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.
Patients with intertrochanteric femur fractures experience significant perioperative and postoperative pain. Perioperative pain can complicate and prolong the anesthesia process for patients undergoing spinal anesthesia, leading to complications in the procedure. Postoperative pain, in turn, prolongs hospital stays, delays recovery, and can lead to chronic postoperative pain due to high-dose opioid use for pain control.
The aim of this single-center, prospective, observational study is to compare the effects of pericapsular nerve block and anterior quadratus lumborum block on spinal anesthesia positioning pain and postoperative analgesia in patients undergoing surgery for intertrochanteric femur fractures. Our study distinguishes itself by providing scientific guidance, as there are no studies in the literature comparing the effects of these two blocks on spinal anesthesia positioning pain, spinal anesthesia success, and postoperative analgesia.
Detailed description
A prospective observational study was planned to be conducted in the operating room of Erzincan Mengücek Gazi Training and Research Hospital. The study will be initiated after approval from the university ethics committee and written informed consent from the patients. A minimum of 64 patients aged 30-85 with elective intertrochanteric femur fractures scheduled for surgery under spinal anesthesia by the orthopedic clinic and ASA I, II, or III will be included in the study. Patients with an ASA risk score of IV or higher, those undergoing emergency surgery, those who refused the study or wished to withdraw later, those with Alzheimer's dementia delirium-like cognitive dysfunction, those with a history of local anesthetic drug toxicity, those with an infection at the block site, those with bleeding diatheses, those undergoing additional surgery or additional anesthetic procedures (general anesthesia), those with a history of chronic opioid use, and those receiving neuropathic pain medication will be excluded from the study. The study will be conducted over a 6-month period from May 19, 2025, to November 19, 2025. All patients will be informed about the study protocol and the procedures to be performed the day before surgery, and written informed consent will be obtained. Patients who are admitted to the preoperative preparation room in the operating room and who undergo routine preoperative monitoring and receive routine ultrasound-guided pericapsular nerve block (PENG) will be included in Group P, and those who undergo routine ultrasound-guided anterior quadratus lumborum block (QLB-3) will be included in Group Q. As is the routine perioperative approach, nasal oxygen will be administered at 2 L/min.
Patients will be transferred to the operating table for spinal anesthesia 30 minutes after the block. Hemodynamic data (SpO2, blood pressure, and pulse rate) will be recorded as is the routine preoperative and intraoperative process. During this process, the patient's resting pain before the block, dynamic pain before the block (leg pain at 15 degrees of elevation), resting pain at 30 minutes after the block, dynamic pain at 30 minutes after the block (leg pain at 15 degrees of elevation), and pain in the given position during spinal anesthesia will be recorded using a numerical rating scale (NRS). (The Numerical Rating Scale (NRS) is a pain score used to rate pain. During this score measurement, patients are asked to verbally state a number that corresponds to their pain, place a check mark on the number indicating their pain, or point to the number. The scale ranges from 0 to 10. 0 indicates no pain, while 10 represents the worst possible pain. Additionally, the anesthesiologist's block application times and whether spinal anesthesia was successful on the first attempt will be recorded. Patients in each group will be included in the group based on their demographic characteristics. After the procedure, patients will be admitted to the postoperative care unit as usual. Patients with an Aldrete score >9 will be transferred to the ward (The Aldrete Scoring System is a scoring system that reflects physiological recovery after anesthesia. This system examines five parameters: muscle activity, respiration, circulation, consciousness, and oxygen saturation. Each parameter is assigned a score of 0, 1, or 2, with a maximum total score of 10).
Patients' rest pain will be assessed and recorded using a numerical rating scale (NRS) at 1 hour, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively. All patients will be routinely administered 50 mg dexketoprofen intravenously three times daily for postoperative analgesia. Additionally, as is routinely done for postoperative pain management in our hospital's orthopedic department, 1 mg/kg tramadol will be administered intravenously as rescue analgesia if the patient's Numerical Rating Scale (NRS) score is 4 or higher (Rescue analgesia is an additional analgesic procedure performed when pain persists despite routine analgesic treatment). Tramadol dosing intervals will be planned to be no less than 6 hours, and the maximum daily tramadol dose will not exceed 400 mg. The total number of analgesic medications (NSAIDs or opioids) used in addition to the nerve block administered for pain control within 24 hours postoperatively will be recorded. For postoperative patient monitoring, patients will be evaluated by a physician who is unaware of the type of block administered.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grup P-Pericapsular Nerve Block | – | –Among the patients taken to the preoperative preparation room in the operating room, those who received routine ultrasound-guided pericapsular nerve block (PENG) following routine preoperative monitoring will be added to Group P. Pain measurement will be evaluated according to the NRS scale. |
| Grup Q-Anterior Quadratus Lumborum Block | – | –Among the patients taken to the preoperative preparation room in the operating room, those who underwent routine ultrasound-guided anterior quadratus lumborum (QLB-3) following routine preoperative monitoring will be added to Group Q. Pain measurement will be evaluated according to the NRS scale. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It was calculated that a minimum of 64 patients should be included in the study. Patients between the ages of 30 and 85 who are scheduled for intertrochanteric femur fracture surgery by the orthopedics and traumatology clinic will be included in the study.
Key inclusion criteria (3 listed)
- Patients scheduled for elective intertrochanteric femur fracture surgery
- Patients with ASA I, II, or III risk scores
- Patients aged 30-85
Key exclusion criteria (9 listed)
- Patients with an ASA risk score of IV or higher
- Patients undergoing emergency surgery
- Patients who refuse to participate in the study or wish to withdraw afterward
- Patients with cognitive dysfunction such as Alzheimer's, dementia, or delirium
- Patients with a history of local anesthetic drug toxicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numeric Rating Scale
Time frame: 24 hours
The numerical rating scale (NRS) is a pain score used to rate pain. Patients are asked to verbally indicate a number that matches their pain, place a check mark on the number indicating their pain, or point to the number. The scale ranges from 0 to 10. 0 indicates no pain, while 10 represents the worst possible pain.
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 17 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Pain and Fracture Femur, run by Erzincan 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 3 inclusion and 9 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 17 Aug 2026. 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?
Numeric Rating Scale (time frame: 24 hours). 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 17 Aug 2026.