Opioid UseNCT06443892
Comparison of Pain Relief After Hip Fracture Surgery: Hip and Groin Nerve Block
An observational study of Opioid Use and Pain, Postoperative, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This observational prospective double-blind study aims to compare the analgesic effectiveness of the pericapsular nerve group block (PENG) group and the suprainguinal fascia iliaca compartment block(SFICB) group to be applied to relieve postoperative pain in participants over the age of 18 who will be treated under… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Pain, Postoperative, Hip Fractures
- What is being tested?
- Pericapsular Nerve Block (PENG) and Suprainguinal Fascia Iliaca Compartment Block (SFICB)
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Jul 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who underwent surgery under spinal anesthesia with interthorachanteric femur fracture over the age of 18
Who may be able to join
- Those with Interthorachanteric Femur Fracture
- Patients over 18 years of age
- ASA I-II-III
- Fully oriented and able to cooperate
- Patients who underwent PENG or Suprainguinal Fascia iliaca compartment block for postoperative analgesia after elective surgery.
Who cannot join
- ASA IV-V
- Patients under 18 years of age
- Presence of active infection in the area to be treated
- Chronic analgesic use
- Patients who cannot cooperate with postoperative pain follow-ups
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Çam Ve Sakura City Hospital
Istanbul
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Pericapsular Nerve Block (PENG) and Suprainguinal Fascia Iliaca Compartment Block(SFICB) in Intertrochanteric Femur Fractures
This observational prospective double-blind study aims to compare the analgesic effectiveness of the pericapsular nerve group block (PENG) group and the suprainguinal fascia iliaca compartment block(SFICB) group to be applied to relieve postoperative pain in participants over the age of 18 who will be treated under spinal anesthesia with intertrochanteric femur fracture. The main question it aims to answer is:
- Demonstration of whether PENG block or SFICB is more effective for postoperative analgesia in patients who have undergone intertrochanteric femur fracture surgery, based on pain scores, opioid consumption and patient satisfaction.
Read more
ıntertrochanteric femur fractures cause severe pain with movement. Postoperatively, participants' movements are severely restricted, increasing the likelihood of complications.
In this study, participants' pain status, VAS score, opioid consumption through patient-controlled analgesia, and satisfaction will be measured with a survey at the end of the 24th hour.
Read the detailed description
Intertrochanteric femoral fracture accounts for approximately 45% to 50% of all hip fractures. Intertrochanteric femur fractures cause severe pain with movement. Postoperatively, the movements of the participants are severely restricted, which increases the risk of deep vein thrombosis in the lower extremities, pulmonary infection and mortality in the participants.
Peripheral nerve blocks have been shown to have less impact on hemodynamics, respiratory function, and consciousness than systemic pain relief options. It is recommended as a first-line analgesia program, especially for hip surgeries, with its features of shortening postoperative recovery time, reducing the risk of pneumonia, and not hindering postoperative movement. Fascia Iliaca compartment block used in this area is safe and widely used in postoperative hip fractures. However, to provide effective analgesia for hip surgery, it is necessary to simultaneously block the femoral nerve, lateral femoral cutaneous nerve, and obturator nerve. It has been reported that suprainguinal fascia iliaca compartment block does not provide adequate analgesia and does not reduce opioid consumption because the obturatory nerve cannot be blocked. Therefore, blocking the femoral nerve, obturatory nerve and accessory obturatory nerves with PENG block has led to the idea that postoperative pain scores and opioid consumption will decrease significantly. In this study, we aim to compare the effectiveness of suprainguinal fascia iliaca compartment block and PENG block for postoperative analgesia based on pain scores and opioid consumption in intertrochanteric femur fractures.
Pain is a symptom known to be subjective, and in order to minimize differences between participants, it will be questioned with the Numeric Rating Scale (NRS), which is a standardized scale.
The total narcotic analgesic needs of the block-treated participants will be recorded with the PCA device inserted intravenously postoperatively, and their total Tramadol consumption will be recorded.
Mobilization start times and pain during the mobilization process will be questioned with the Turkish-American Pain Society Revised Patient Outcomes Survey.
The Turkish version of the revised American Pain Society patient outcomes survey for surgical patients will be used to evaluate participants' satisfaction with pain management. According to the confirmatory factor analysis fit indices of the Turkish-Revised American Pain Society Patient Outcomes Questionnaire, whose Cronbach's Alpha value was calculated as 0.88, its three-factor structure was found to be appropriate. The Turkish-Revised American Pain Society Patient Outcomes Questionnaire is a tool to improve the quality of pain management for adult patients. With this questionnaire (1) pain intensity and relief; (2) the impact of pain on activity, sleep, and negative emotions; (3) medication side effects; (4) usefulness of pain management information;(5) ability to participate in pain management decisions; and (6) the use of non-pharmacological techniques will be questioned.
Demographic characteristics of the participants, comorbidities, operation times and complications will be recorded and analyzed statistically.
- Conditions
- Opioid Use, Pain, Postoperative, Hip Fractures
- Being tested
- Pericapsular Nerve Block (PENG), Suprainguinal Fascia Iliaca Compartment Block (SFICB)
- Medical subject headings
- Pain, Postoperative, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular Nerve Block (PENG)Procedure or surgery
Evaluation of postoperative analgesic efficacy of PENG block in participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia.
Suprainguinal Fascia Iliaca Compartment Block (SFICB)Procedure or surgery
Evaluation of postoperative analgesic efficacy of SFICB block in participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| PENG Group | Participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia and receiving postoperative pericapsular nerve block (PENG). Receives: Procedure: Pericapsular Nerve Block (PENG) | |
| SFICB Group | Participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia and receiving postoperative suprainguinal fascia iliaca compartment block (SFICB). Receives: Procedure: Suprainguinal Fascia Iliaca Compartment Block (SFICB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness on pain scores
Postoperative pain assessment is performed using the Numerical Rating Scale (NRS). Participants are asked about their rest pain at 0, 1, 6, 12 and 24 hours after applying a postoperative peripheral nerve block. With this method, participants rate their pain with a precise numerical value from 0 to 10. While zero(0) represents "no pain"; Ten (10) represents the opposite end of the pain continuum (e.g., "The most intense pain imaginable," "As intense pain as possible," "Maximum pain").
Measured: At 0, 1, 6, 12 and 24 hours after postoperative peripheral nerve block application
Secondary outcomes (1)
Effect on total narcotic analgesic consumption
After the surgery, participants will receive a peripheral nerve block procedure in the postoperative anesthetic care area, and then simultaneously receive intravenous patient-controlled analgesia (PCA) and start an infusion. "Tramadol" was preferred as the treatment method to be used for the PCA method. In preparation for PCA, 400 mg of tramadol is added to 100 cc of physiological saline. As PCA protocol, 1 cc/hour (4 mg/hour) basal infusion dose, 5 cc (20 mg) bolus dose, 30 minutes lockout period (maximum 2 bolus doses in 1 hour) are set. The total number of bolus doses administered by the participants on the PCA device at the end of 24 hours will be recorded and evaluated as the amount of additional opioid needed.
Measured: Total number of bolus doses administered at the end of 24 hours of the intravenous PCA device inserted simultaneously after postoperative peripheral nerve block application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 May 2023
- Primary completion31 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muzaffer GENCER, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443892
- Sponsor's protocol ID
- BSH-ANES-MA-01
- Status last verified
- Jan 2025
- First submitted
- 24 May 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657Mosaffa F, Taheri M, Manafi Rasi A, Samadpour H, Memary E, Mirkheshti A. Comparison of pericapsular nerve group (PENG) block with fascia iliaca compartment block (FICB) for pain control in hip fractures: A double-blind prospective randomized controlled clinical trial. Orthop Traumatol Surg Res. 2022 Feb;108(1):103135. doi: 10.1016/j.otsr.2021.103135. Epub 2021 Oct 29.
PubMed 34715388Kong M, Tang Y, Tong F, Guo H, Zhang XL, Zhou L, Ni H, Wang B, Liu Y, Liu J. The analgesic efficacy of pericapsular nerve group block in patients with intertrochanteric femur fracture: A randomized controlled trial. PLoS One. 2022 Oct 13;17(10):e0275793. doi: 10.1371/journal.pone.0275793. eCollection 2022.
PubMed 36227845Allard C, Pardo E, de la Jonquiere C, Wyniecki A, Soulier A, Faddoul A, Tsai ES, Bonnet F, Verdonk F. Comparison between femoral block and PENG block in femoral neck fractures: A cohort study. PLoS One. 2021 Jun 4;16(6):e0252716. doi: 10.1371/journal.pone.0252716. eCollection 2021.
PubMed 34086782Choi YS, Park KK, Lee B, Nam WS, Kim DH. Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca Compartment Block for Total Hip Arthroplasty: A Randomized Clinical Trial. J Pers Med. 2022 Mar 6;12(3):408. doi: 10.3390/jpm12030408.
PubMed 35330408Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
PubMed 21401544
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Pericapsular Nerve Block (PENG) and Suprainguinal Fascia Iliaca Compartment Block(SFICB) in Intertrochanteric Femur Fractures
- ClinicalTrials.gov ID
- NCT06443892
- Acronym / sponsor ID
- BSH-ANES-MA-01
- Conditions
- Opioid Use, Pain, Postoperative, Hip Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 5 Jun 2024 (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.
This observational prospective double-blind study aims to compare the analgesic effectiveness of the pericapsular nerve group block (PENG) group and the suprainguinal fascia iliaca compartment block(SFICB) group to be applied to relieve postoperative pain in participants over the age of 18 who will be treated under spinal anesthesia with intertrochanteric femur fracture. The main question it aims to answer is:
- Demonstration of whether PENG block or SFICB is more effective for postoperative analgesia in patients who have undergone intertrochanteric femur fracture surgery, based on pain scores, opioid consumption and patient satisfaction.
ıntertrochanteric femur fractures cause severe pain with movement. Postoperatively, participants' movements are severely restricted, increasing the likelihood of complications.
In this study, participants' pain status, VAS score, opioid consumption through patient-controlled analgesia, and satisfaction will be measured with a survey at the end of the 24th hour.
Detailed description
Intertrochanteric femoral fracture accounts for approximately 45% to 50% of all hip fractures. Intertrochanteric femur fractures cause severe pain with movement. Postoperatively, the movements of the participants are severely restricted, which increases the risk of deep vein thrombosis in the lower extremities, pulmonary infection and mortality in the participants.
Peripheral nerve blocks have been shown to have less impact on hemodynamics, respiratory function, and consciousness than systemic pain relief options. It is recommended as a first-line analgesia program, especially for hip surgeries, with its features of shortening postoperative recovery time, reducing the risk of pneumonia, and not hindering postoperative movement. Fascia Iliaca compartment block used in this area is safe and widely used in postoperative hip fractures. However, to provide effective analgesia for hip surgery, it is necessary to simultaneously block the femoral nerve, lateral femoral cutaneous nerve, and obturator nerve. It has been reported that suprainguinal fascia iliaca compartment block does not provide adequate analgesia and does not reduce opioid consumption because the obturatory nerve cannot be blocked. Therefore, blocking the femoral nerve, obturatory nerve and accessory obturatory nerves with PENG block has led to the idea that postoperative pain scores and opioid consumption will decrease significantly. In this study, we aim to compare the effectiveness of suprainguinal fascia iliaca compartment block and PENG block for postoperative analgesia based on pain scores and opioid consumption in intertrochanteric femur fractures.
Pain is a symptom known to be subjective, and in order to minimize differences between participants, it will be questioned with the Numeric Rating Scale (NRS), which is a standardized scale.
The total narcotic analgesic needs of the block-treated participants will be recorded with the PCA device inserted intravenously postoperatively, and their total Tramadol consumption will be recorded.
Mobilization start times and pain during the mobilization process will be questioned with the Turkish-American Pain Society Revised Patient Outcomes Survey.
The Turkish version of the revised American Pain Society patient outcomes survey for surgical patients will be used to evaluate participants' satisfaction with pain management. According to the confirmatory factor analysis fit indices of the Turkish-Revised American Pain Society Patient Outcomes Questionnaire, whose Cronbach's Alpha value was calculated as 0.88, its three-factor structure was found to be appropriate. The Turkish-Revised American Pain Society Patient Outcomes Questionnaire is a tool to improve the quality of pain management for adult patients. With this questionnaire (1) pain intensity and relief; (2) the impact of pain on activity, sleep, and negative emotions; (3) medication side effects; (4) usefulness of pain management information;(5) ability to participate in pain management decisions; and (6) the use of non-pharmacological techniques will be questioned.
Demographic characteristics of the participants, comorbidities, operation times and complications will be recorded and analyzed statistically.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG Group | – | Procedure: Pericapsular Nerve Block (PENG)Participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia and receiving postoperative pericapsular nerve block (PENG). |
| SFICB Group | – | Procedure: Suprainguinal Fascia Iliaca Compartment Block (SFICB)Participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia and receiving postoperative suprainguinal fascia iliaca compartment block (SFICB). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who underwent surgery under spinal anesthesia with interthorachanteric femur fracture over the age of 18
Key inclusion criteria (5 listed)
- Those with Interthorachanteric Femur Fracture
- Patients over 18 years of age
- ASA I-II-III
- Fully oriented and able to cooperate
- Patients who underwent PENG or Suprainguinal Fascia iliaca compartment block for postoperative analgesia after elective surgery.
Key exclusion criteria (5 listed)
- ASA IV-V
- Patients under 18 years of age
- Presence of active infection in the area to be treated
- Chronic analgesic use
- Patients who cannot cooperate with postoperative pain follow-ups
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 |
|---|---|---|
| Pericapsular Nerve Block (PENG)Evaluation of postoperative analgesic efficacy of PENG block in participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia. | Procedure or surgery | PENG Group |
| Suprainguinal Fascia Iliaca Compartment Block (SFICB)Evaluation of postoperative analgesic efficacy of SFICB block in participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia. | Procedure or surgery | SFICB Group |
Primary outcome
Effectiveness on pain scores
Time frame: At 0, 1, 6, 12 and 24 hours after postoperative peripheral nerve block application
Postoperative pain assessment is performed using the Numerical Rating Scale (NRS). Participants are asked about their rest pain at 0, 1, 6, 12 and 24 hours after applying a postoperative peripheral nerve block. With this method, participants rate their pain with a precise numerical value from 0 to 10. While zero(0) represents "no pain"; Ten (10) represents the opposite end of the pain continuum (e.g., "The most intense pain imaginable," "As intense pain as possible," "Maximum pain").
1 secondary outcome
Effect on total narcotic analgesic consumption
Time frame: Total number of bolus doses administered at the end of 24 hours of the intravenous PCA device inserted simultaneously after postoperative peripheral nerve block application
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 24 Jan 2025.
- Results publication: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Results publication: PubMed 34715388Mosaffa F, Taheri M, Manafi Rasi A, Samadpour H, Memary E, Mirkheshti A. Comparison of pericapsular nerve group (PENG) block with fascia iliaca compartment block (FICB) for pain control in hip fractures: A double-blind prospective randomized controlled clinical trial. Orthop Traumatol Surg Res. 2022 Feb;108(1):103135. doi: 10.1016/j.otsr.2021.103135. Epub 2021 Oct 29.
- Results publication: PubMed 36227845Kong M, Tang Y, Tong F, Guo H, Zhang XL, Zhou L, Ni H, Wang B, Liu Y, Liu J. The analgesic efficacy of pericapsular nerve group block in patients with intertrochanteric femur fracture: A randomized controlled trial. PLoS One. 2022 Oct 13;17(10):e0275793. doi: 10.1371/journal.pone.0275793. eCollection 2022.
- Results publication: PubMed 34086782Allard C, Pardo E, de la Jonquiere C, Wyniecki A, Soulier A, Faddoul A, Tsai ES, Bonnet F, Verdonk F. Comparison between femoral block and PENG block in femoral neck fractures: A cohort study. PLoS One. 2021 Jun 4;16(6):e0252716. doi: 10.1371/journal.pone.0252716. eCollection 2021.
- Results publication: PubMed 35330408Choi YS, Park KK, Lee B, Nam WS, Kim DH. Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca Compartment Block for Total Hip Arthroplasty: A Randomized Clinical Trial. J Pers Med. 2022 Mar 6;12(3):408. doi: 10.3390/jpm12030408.
- Results publication: PubMed 21401544Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
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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 Opioid Use and Pain, Postoperative, run by Başakşehir Çam & Sakura City Hospital 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 5 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 24 Jan 2025. 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?
Effectiveness on pain scores (time frame: At 0, 1, 6, 12 and 24 hours after postoperative peripheral nerve block application). 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 NCT06443892, which also lists 6 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 24 Jan 2025.