Regional AnesthesiaNCT06295224
Retrospective Evaluation of Effect of Anterior Iliac Block
An observational study of Regional Anesthesia, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to evaluate the effect of ultrasound-guided anterior iliac block which was performed preoperatively. Anterior iliac bone harvesting is associated with severe postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Regional Anesthesia
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 10 Mar 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent anterior iliac graft harvesting and were performed anterior iliac block at Kocaeli University Faculty of Medicine between January 2021 and December 2023 will be included in the study.
Who may be able to join
- ASA-1, ASA-2 and ASA-3 patients
- Female/male
Who cannot join
- Anticoagulant drug use
- Known allergy to the medications to be used
- Infection in the area where the needle will be inserted
- Missing data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Evaluation of Postoperative Analgesia Efficacy of the Anterior Iliac Block in Anterior Iliac Crest Bone Graft Harvesting: Preliminary Study
In this study, the investigators aimed to evaluate the effect of ultrasound-guided anterior iliac block which was performed preoperatively. Anterior iliac bone harvesting is associated with severe postoperative pain. As several fascial plane blocks were defined to provide analgesia, their effects are debatable and requires high volumes of local anesthetic considering the regional anesthesia technique used for the main surgical procedure.
Read the detailed description
Autologous bone grafting is the method called the gold standard in the reconstruction of bone defects and nonunions. Anterior iliac crest is most frequently preferred as the source of autologous bone graft. However, severe pain after anterior iliac crest graft harvesting increases morbidity. Various regional anesthesia techniques have been defined for the purpose of postoperative analgesia. The mechanism of fascial plane blocks, one of these techniques, has not been fully elucidated and drug distribution varies from person to person. Postoperative analgesia of the iliac crest donor site can be achieved by i infiltration of local anesthetics or morphine. Single injection or continuous infusions of local anesthetic have proven effective in adults.
In this study; the investigators aimed to retrospectively scan the records of patients who received anterior iliac bone graft in our clinic and determine the postoperative analgesia effectiveness of anterior iliac block. The data obtained after the research will make a significant contribution to the literature in the postoperative analgesia management of patients who are planned to receive anterior iliac bone graft.
- Conditions
- Regional Anesthesia
- Keywords
- Anterior Iliac Block, Anterior Iliac Crest Bone Harvesting
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 |
|---|---|---|
| Anterior Iliac Block | Patients who were performed anterior iliac block with ultrasound guidance with 10-20 mL 0.25% bupivacaine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Morphine consumption with patient controlled analgesia device
Measured: postoperative 1st hour, 6th hour, 12th hour and 24th hour
Secondary outcomes (1)
NRS score
NRS score at rest
Measured: postoperative 1st hour, 6th hour, 12th hour and 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Jan 2024
- Primary completion5 Mar 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadi Ufuk Yörükoğlu, Kocaeli University
- Investigators
- Hadi Ufuk Yörükoğlu, Principal investigator, Kocaeli University, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295224
- Sponsor's protocol ID
- GOKAEK-2024/02.19
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morgan SJ, Jeray KJ, Saliman LH, Miller HJ, Williams AE, Tanner SL, Smith WR, Broderick JS. Continuous infusion of local anesthetic at iliac crest bone-graft sites for postoperative pain relief. A randomized, double-blind study. J Bone Joint Surg Am. 2006 Dec;88(12):2606-12. doi: 10.2106/JBJS.E.00984.
PubMed 17142410Black ND, Malhas L, Jin R, Bhatia A, Chan VWS, Chin KJ. The analgesic efficacy of the transversalis fascia plane block in iliac crest bone graft harvesting: a randomized controlled trial. Korean J Anesthesiol. 2019 Aug;72(4):336-343. doi: 10.4097/kja.d.18.00352. Epub 2019 Mar 19.
PubMed 30886131Shin SR, Tornetta P 3rd. Donor Site Morbidity After Anterior Iliac Bone Graft Harvesting. J Orthop Trauma. 2016 Jun;30(6):340-3. doi: 10.1097/BOT.0000000000000551.
PubMed 27218470Sondekoppam RV, Ip V, Johnston DF, Uppal V, Johnson M, Ganapathy S, Tsui BCH. Ultrasound-guided lateral-medial transmuscular quadratus lumborum block for analgesia following anterior iliac crest bone graft harvesting: a clinical and anatomical study. Can J Anaesth. 2018 Feb;65(2):178-187. doi: 10.1007/s12630-017-1021-y. Epub 2017 Nov 21.
PubMed 29164530Gundes H, Kilickan L, Gurkan Y, Sarlak A, Toker K. Short- and long-term effects of regional application of morphine and bupivacaine on the iliac crest donor site. Acta Orthop Belg. 2000 Oct;66(4):341-4.
PubMed 11103484Chin KJ, McDonnell JG, Carvalho B, Sharkey A, Pawa A, Gadsden J. Essentials of Our Current Understanding: Abdominal Wall Blocks. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):133-183. doi: 10.1097/AAP.0000000000000545.
PubMed 28085788Ouaki J, Dadure C, Bringuier S, Raux O, Rochette A, Captier G, Capdevila X. Continuous infusion of ropivacaine: an optimal postoperative analgesia regimen for iliac crest bone graft in children. Paediatr Anaesth. 2009 Sep;19(9):887-91. doi: 10.1111/j.1460-9592.2009.03095.x.
PubMed 19691695Yorukoglu HU, Cesur S, Izgin Avci I, GoK A, Aksu C, Selek O, Kus A. Retrospective evaluation of postoperative analgesia efficacy of a new technique in anterior iliac crest bone graft harvesting: anterior iliac block. BMC Anesthesiol. 2024 Nov 29;24(1):443. doi: 10.1186/s12871-024-02829-7.
PubMed 39609729
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Postoperative Analgesia Efficacy of the Anterior Iliac Block in Anterior Iliac Crest Bone Graft Harvesting: Preliminary Study
- ClinicalTrials.gov ID
- NCT06295224
- Acronym / sponsor ID
- GOKAEK-2024/02.19
- Conditions
- Regional Anesthesia
- Keywords
- Anterior Iliac Block, Anterior Iliac Crest Bone Harvesting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 6 Mar 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.
In this study, the investigators aimed to evaluate the effect of ultrasound-guided anterior iliac block which was performed preoperatively. Anterior iliac bone harvesting is associated with severe postoperative pain. As several fascial plane blocks were defined to provide analgesia, their effects are debatable and requires high volumes of local anesthetic considering the regional anesthesia technique used for the main surgical procedure.
Detailed description
Autologous bone grafting is the method called the gold standard in the reconstruction of bone defects and nonunions. Anterior iliac crest is most frequently preferred as the source of autologous bone graft. However, severe pain after anterior iliac crest graft harvesting increases morbidity. Various regional anesthesia techniques have been defined for the purpose of postoperative analgesia. The mechanism of fascial plane blocks, one of these techniques, has not been fully elucidated and drug distribution varies from person to person. Postoperative analgesia of the iliac crest donor site can be achieved by i infiltration of local anesthetics or morphine. Single injection or continuous infusions of local anesthetic have proven effective in adults.
In this study; the investigators aimed to retrospectively scan the records of patients who received anterior iliac bone graft in our clinic and determine the postoperative analgesia effectiveness of anterior iliac block. The data obtained after the research will make a significant contribution to the literature in the postoperative analgesia management of patients who are planned to receive anterior iliac bone graft.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior Iliac Block | – | –Patients who were performed anterior iliac block with ultrasound guidance with 10-20 mL 0.25% bupivacaine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent anterior iliac graft harvesting and were performed anterior iliac block at Kocaeli University Faculty of Medicine between January 2021 and December 2023 will be included in the study.
Key inclusion criteria (2 listed)
- ASA-1, ASA-2 and ASA-3 patients
- Female/male
Key exclusion criteria (4 listed)
- Anticoagulant drug use
- Known allergy to the medications to be used
- Infection in the area where the needle will be inserted
- Missing data
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
Morphine consumption
Time frame: postoperative 1st hour, 6th hour, 12th hour and 24th hour
Morphine consumption with patient controlled analgesia device
1 secondary outcome
NRS score
Time frame: postoperative 1st hour, 6th hour, 12th hour and 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 6 Mar 2025.
- Background: PubMed 17142410Morgan SJ, Jeray KJ, Saliman LH, Miller HJ, Williams AE, Tanner SL, Smith WR, Broderick JS. Continuous infusion of local anesthetic at iliac crest bone-graft sites for postoperative pain relief. A randomized, double-blind study. J Bone Joint Surg Am. 2006 Dec;88(12):2606-12. doi: 10.2106/JBJS.E.00984.
- Background: PubMed 30886131Black ND, Malhas L, Jin R, Bhatia A, Chan VWS, Chin KJ. The analgesic efficacy of the transversalis fascia plane block in iliac crest bone graft harvesting: a randomized controlled trial. Korean J Anesthesiol. 2019 Aug;72(4):336-343. doi: 10.4097/kja.d.18.00352. Epub 2019 Mar 19.
- Background: PubMed 27218470Shin SR, Tornetta P 3rd. Donor Site Morbidity After Anterior Iliac Bone Graft Harvesting. J Orthop Trauma. 2016 Jun;30(6):340-3. doi: 10.1097/BOT.0000000000000551.
- Background: PubMed 29164530Sondekoppam RV, Ip V, Johnston DF, Uppal V, Johnson M, Ganapathy S, Tsui BCH. Ultrasound-guided lateral-medial transmuscular quadratus lumborum block for analgesia following anterior iliac crest bone graft harvesting: a clinical and anatomical study. Can J Anaesth. 2018 Feb;65(2):178-187. doi: 10.1007/s12630-017-1021-y. Epub 2017 Nov 21.
- Background: PubMed 11103484Gundes H, Kilickan L, Gurkan Y, Sarlak A, Toker K. Short- and long-term effects of regional application of morphine and bupivacaine on the iliac crest donor site. Acta Orthop Belg. 2000 Oct;66(4):341-4.
- Background: PubMed 28085788Chin KJ, McDonnell JG, Carvalho B, Sharkey A, Pawa A, Gadsden J. Essentials of Our Current Understanding: Abdominal Wall Blocks. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):133-183. doi: 10.1097/AAP.0000000000000545.
- Background: PubMed 19691695Ouaki J, Dadure C, Bringuier S, Raux O, Rochette A, Captier G, Capdevila X. Continuous infusion of ropivacaine: an optimal postoperative analgesia regimen for iliac crest bone graft in children. Paediatr Anaesth. 2009 Sep;19(9):887-91. doi: 10.1111/j.1460-9592.2009.03095.x.
- Derived from this study: PubMed 39609729Yorukoglu HU, Cesur S, Izgin Avci I, GoK A, Aksu C, Selek O, Kus A. Retrospective evaluation of postoperative analgesia efficacy of a new technique in anterior iliac crest bone graft harvesting: anterior iliac block. BMC Anesthesiol. 2024 Nov 29;24(1):443. doi: 10.1186/s12871-024-02829-7.
- 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.
Hadi Ufuk Yörükoğlu principal investigator
Kocaeli University, Department of Anesthesiology and Reanimation
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 Regional Anesthesia, run by Kocaeli 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 4 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 6 Mar 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?
Morphine consumption (time frame: postoperative 1st hour, 6th hour, 12th hour and 24th hour). 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 NCT06295224, which also lists 8 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 6 Mar 2025.