Post Operative PainNCT05632536
Comparison of Analgesic Efficacy of ESP Block and Caudal Block in Patients Undergoing Hypospadias Surgery
A study testing SACRAL ESP AND CAUDAL BLOCK in people with Post Operative Pain and Hypospadias, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of clinical trial is to compare in of analgesic efficacy of sacrale erector spinae plane (ESP) block and caudal block in participants undergoing hypospadias surgery. Investigators will include children between the ages of 6 months and 7 years in the 1st and 2nd categories in the ASA. Read more about this study
- Who is it for?
- Ages 6 months to 7 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Hypospadias
- What is being tested?
- SACRAL ESP AND CAUDAL BLOCK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2022to 19 Dec 2023
- 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 6 months to 7 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- American Society of Anesthesiology (ASA) I-II group
- 6 months to 7 years old
- Paediatric age group patients who will undergo hypospadias surgery under general anesthesia
Who cannot join
- ASA III - IV patient group
- Patients who were operated on urgently
- Patient relatives who did not give consent
- Presence of local anesthetic allergy
- Presence of infection in the area to be blocked
- Presence of coagulation disorder
Show all 10Show fewer
- Severe organ failure
- Pre-existing neurological deficit
- Mental Retardation
- Anatomical Deformity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Research and Training Hospital
Sarıyer, Istanbul, 34450
About this study
Official title: Comparison of Analgesic Efficacy of Sacral erectOR Spinae Plane Block and Caudal Block in Patients Undergoing Hypospadias Surgery
The goal of clinical trial is to compare in of analgesic efficacy of sacrale erector spinae plane (ESP) block and caudal block in participants undergoing hypospadias surgery. Investigators will include children between the ages of 6 months and 7 years in the 1st and 2nd categories in the ASA.
In this study, investigators seek answers to the following questions:
Which of the sacral (ESP) block and caudal block applied to participants undergoing hypospadias surgery has higher postoperative analgesic efficiency than the other? Which of the sacral ESP block and caudal block applied to participants undergoing hypospadias surgery is superior in duration of analgesia? After general anesthesia is administered to the participants, one of the 2 blocks will be administered in a randomized manner and the relevant data will be recorded. This research will be conducted in a single center as a prospective randomized controlled study. It was planned to include 60 participnts from the ASA I-II pediatric participants aged between 6 months and 7 years, who will undergo hypospadias surgery between December 2022-December 2023, and randomization will be done by closed envelope method. Two groups with sacral ESP and caudal block will be formed, each with 30 participants.
Read the detailed description
This study will be conducted as a prospective, randomized controlled trial at a single center between December 2022 and December 2023. Sixty pediatric participants, aged 6 months to 7 years, classified as ASA I-II, who are scheduled for hypospadias surgery, will be included. Participants will be randomized into two groups: ESP block group and caudal block group, with 30 participants in each group. Randomization will be done using a sealed envelope technique based on computer-generated random numbers..
The study was planned to be performed as a double blind. Sacral ESP and caudal block will be administered by an anesthesiologist not responsible for the perioperative and postoperative management of the participants. A second anesthesiologist, who will be in charge of monitoring and data recording, will be unaware of the participants' group assignments. Additionally, parents, surgeons, and other personnel involved in the data collection process will be unaware of the group to which the child is assigned. Surgeons will not be present in the operating room while the anesthesiologist administers the block (sacral ESP block or caudal block). All participants will undergo aseptic skin preparation using Betadine. Since bandages will be applied to two points, the actual injection site will not be known.
The age, height, weight, gender and ASA scores of the participants in both groups will be recorded.
After the participants are taken to the operation table, standard monitoring will be performed. Heart rate (HR), mean arterial pressure (MAP), body temperature, peripheral oxygen saturation (SpO2) will be monitored and all parameters before surgical incision, after surgical incision, before awakening, postoperative 5 and 30 minutes will be recorded.
All participants will be placed in an IV cannula using 8% sevoflurane in 50/50 O2 / air for 2 - 4 minutes with a face mask, followed by induction of inhaled anesthesia. All participants will be placed in I-gel (supraglottic airway vehicle) by performing routine induction of general anesthesia with propofol 2-3 mg kg-1, fentanyl 1 mcg kg-1. Participants will have mechanical ventilatory support and tidal volume will be set to 8- 10 ml/kg and minute breathing will be set to 16-26. The end tidal carbon dioxide will be kept between 35-40 mmHg. Anesthesia maintenance will be provided with a starting dose of sevoflurane 2% and IV remifentanil 0.05 mcg kg-1 min-1 with a flow of 3 Lt min-1, an Oxygen/air mixture. >20% increase in intraoperative heart rate will be evaluated as pain and remifentanil dose will be increased and the need for remifentanil used intraoperatively will be recorded.
Group ESP (n=30) participants will be given a lateral decubitus position under general anesthesia before the operation and sacral ESP block will be performed accompanied by ultrasound. Group C (n=30) participants who will undergo caudal block will also be given a lateral decubitus position and ultrasound-guided block will be performed.
After 15 minutes of block surgery will be initiated. All operations will be performed by the same experienced team with the same surgical technique.
Near the end of the operation, 15 mg kg-1 IV paracetamol will be given. At the end of the operation, the duration of operation will be recorded.
Pain scoring system Face, Legs, Activity, Cry, Consolability (FLACC) will be recorded in 5th and 30th minutes and 1st, 2nd, 4th, 6th, 12th, 24th hours.
At the end of the operation, the time when there is a need for analgesia will be evaluated as "the first need for analgesia (hour)".
Total amount of additional analgesia (oral paracetamol, mg), amount of rescue analgesia (oral ibuprofen, mg), participants' relative satisfaction (1-Not satisfied, 2-Satisfied, 3-Very satisfied) will be recorded.
Motor weakness, neurological deficit, urinary retention, nausea, vomiting, hypotension, bradycardia, itching, local anesthetic toxicity and bleeding that may occur will be recorded.
- Conditions
- Post Operative Pain, Hypospadias
- Being tested
- SACRAL ESP AND CAUDAL BLOCK
- Keywords
- sacral erector spinae plane block, caudal block, hypospadias, pediatric surgery
- Medical subject headings
- Pain, Postoperative, Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SACRAL ESP AND CAUDAL BLOCKProcedure or surgery
Application of ultrasound-guided sacral erector spinae plane (ESP) block or ultrasound-guided caudal block with 1mL/kg 0.25% bupivacaine (local anesthetic) to patients
| Study group | Role | What they receive |
|---|---|---|
| GROUP ESP | Active comparator | Before the operation, under general anesthesia, group ESP (n=30) patients will be blocked with the sacral ESP block method. By giving the lateral decubitus position, the linear ultrasound probe will be placed in the sterilized area longitudinally on the midline of the sacrum. The erector spinae muscle and the sacral medial crest will be visualized. The 22 gauge, 50 mm needle will be advanced in the direction from cranial to caudal to reach the sacral crest. 0.25% bupivacaine from a dose of 1 mL kg-1 will be aspirated and injected every 2 mL under the erector spina muscle at the level of the median sacral crest at the level of the 4th sacral vertebra. (A test dose will be administered with 1 mL of saline.) Receives: Procedure: SACRAL ESP AND CAUDAL BLOCK |
| GROUP C | Sham comparator | Group C (n=30) patients to whom caudal block will be applied will be placed in the lateral decubitus position and the linear ultrasound probe will be placed longitudinally in the sterilized area on the midline of the sacrum. A 2.5 cm 22 gauge needle will be inserted over the back skin of the sacral hiatus (located distal to the sacrum and formed by the two sacral cornua on its lateral edges) at a 90° position. The sacrococcygeal ligament will be crossed, the needle will be oriented approximately 25° and advanced approximately 2 to 3 mm to reach the sacral canal. After entering the sacral hiatus and confirming the location with negative aspiration method, 1 mL kg-1 0.25% bupivacaine will be injected by aspiration every 2 mL (test dose will be administered with 1 mL saline). Receives: Procedure: SACRAL ESP AND CAUDAL BLOCK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the analgesia
The duration that elapsed between block application and the patient\'s first analgesic requirement (if FLACC\>3) was evaluated and recorded as \'\'duration of analgesia (hours)\'\'
Measured: 1 year
Secondary outcomes (2)
Evaluation of the analgesic effects of sacral ESP and caudal block with Face/ Leg/ Activity/ Cry/ Consolability (FLACC) scores in patients undergoing hypospadias surgery.
Evaluation of the analgesic effects of sacral ESP and caudal block with FLACC scores in patients undergoing hypospadias surgery. According to this scoring system, each category is between 0-2, The total score ranges from 0 to 10. 0 points that the game is calm and relaxed, between 1-3 score players are mildly disturbing, scores 4-6 games are moderate He had surgery, scores between 7-10 the player is noticeably disturbing, Pain or harm together reports that
Measured: 1 year
Morphine consumption
Number of patients requiring postoperative morphine, and total postoperative morphine (first 24 hours postoperatively) requirement were recorded.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start21 Dec 2022
- Primary completion18 Dec 2023
- Study completion19 Dec 2023
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 Post Operative 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our research will be conducted in a single center as a prospective randomized controlled study. It was planned to include 60 patients from the ASA I-II pediatric patient group aged between 6 months and 7 years, who will undergo hypospadias surgery in our hospital between December 2022 and December 2023, and randomization will be done by closed envelope method. Two groups with sacral ESP and caudal block will be formed, each with 30 patients.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Kesici, MD, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Sevgi KESİCİ, Principal investigator, Sisli Etfal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632536
- Sponsor's protocol ID
- 240819
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2022
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mostafa SF, Abdelghany MS, Abdelraheem TM, Abu Elyazed MM. Ultrasound-guided erector spinae plane block for postoperative analgesia in pediatric patients undergoing splenectomy: A prospective randomized controlled trial. Paediatr Anaesth. 2019 Dec;29(12):1201-1207. doi: 10.1111/pan.13758. Epub 2019 Nov 8.
PubMed 31630465Aksu C, Gurkan Y. Sacral Erector Spinae Plane Block with longitudinal midline approach: Could it be the new era for pediatric postoperative analgesia? J Clin Anesth. 2020 Feb;59:38-39. doi: 10.1016/j.jclinane.2019.06.007. Epub 2019 Jun 13. No abstract available.
PubMed 31203111Kundra P, Yuvaraj K, Agrawal K, Krishnappa S, Kumar LT. Surgical outcome in children undergoing hypospadias repair under caudal epidural vs penile block. Paediatr Anaesth. 2012 Jul;22(7):707-12. doi: 10.1111/j.1460-9592.2011.03702.x. Epub 2011 Sep 29.
PubMed 21957982Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20.
PubMed 32507565Kaya C, Dost B, Tulgar S. Sacral Erector Spinae Plane Block Provides Surgical Anesthesia in Ambulatory Anorectal Surgery: Two Case Reports. Cureus. 2021 Jan 9;13(1):e12598. doi: 10.7759/cureus.12598.
PubMed 33585088Topdagi Yilmaz EP, Oral Ahiskalioglu E, Ahiskalioglu A, Tulgar S, Aydin ME, Kumtepe Y. A Novel Multimodal Treatment Method and Pilot Feasibility Study for Vaginismus: Initial Experience With the Combination of Sacral Erector Spinae Plane Block and Progressive Dilatation. Cureus. 2020 Oct 8;12(10):e10846. doi: 10.7759/cureus.10846.
PubMed 33178502
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Sacral erectOR Spinae Plane Block and Caudal Block in Patients Undergoing Hypospadias Surgery
- ClinicalTrials.gov ID
- NCT05632536
- Acronym / sponsor ID
- 240819
- Conditions
- Post Operative Pain, Hypospadias
- Keywords
- sacral erector spinae plane block, caudal block, hypospadias, pediatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 30 Nov 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.
The goal of clinical trial is to compare in of analgesic efficacy of sacrale erector spinae plane (ESP) block and caudal block in participants undergoing hypospadias surgery. Investigators will include children between the ages of 6 months and 7 years in the 1st and 2nd categories in the ASA.
In this study, investigators seek answers to the following questions:
Which of the sacral (ESP) block and caudal block applied to participants undergoing hypospadias surgery has higher postoperative analgesic efficiency than the other? Which of the sacral ESP block and caudal block applied to participants undergoing hypospadias surgery is superior in duration of analgesia? After general anesthesia is administered to the participants, one of the 2 blocks will be administered in a randomized manner and the relevant data will be recorded. This research will be conducted in a single center as a prospective randomized controlled study. It was planned to include 60 participnts from the ASA I-II pediatric participants aged between 6 months and 7 years, who will undergo hypospadias surgery between December 2022-December 2023, and randomization will be done by closed envelope method. Two groups with sacral ESP and caudal block will be formed, each with 30 participants.
Detailed description
This study will be conducted as a prospective, randomized controlled trial at a single center between December 2022 and December 2023. Sixty pediatric participants, aged 6 months to 7 years, classified as ASA I-II, who are scheduled for hypospadias surgery, will be included. Participants will be randomized into two groups: ESP block group and caudal block group, with 30 participants in each group. Randomization will be done using a sealed envelope technique based on computer-generated random numbers..
The study was planned to be performed as a double blind. Sacral ESP and caudal block will be administered by an anesthesiologist not responsible for the perioperative and postoperative management of the participants. A second anesthesiologist, who will be in charge of monitoring and data recording, will be unaware of the participants' group assignments. Additionally, parents, surgeons, and other personnel involved in the data collection process will be unaware of the group to which the child is assigned. Surgeons will not be present in the operating room while the anesthesiologist administers the block (sacral ESP block or caudal block). All participants will undergo aseptic skin preparation using Betadine. Since bandages will be applied to two points, the actual injection site will not be known.
The age, height, weight, gender and ASA scores of the participants in both groups will be recorded.
After the participants are taken to the operation table, standard monitoring will be performed. Heart rate (HR), mean arterial pressure (MAP), body temperature, peripheral oxygen saturation (SpO2) will be monitored and all parameters before surgical incision, after surgical incision, before awakening, postoperative 5 and 30 minutes will be recorded.
All participants will be placed in an IV cannula using 8% sevoflurane in 50/50 O2 / air for 2 - 4 minutes with a face mask, followed by induction of inhaled anesthesia. All participants will be placed in I-gel (supraglottic airway vehicle) by performing routine induction of general anesthesia with propofol 2-3 mg kg-1, fentanyl 1 mcg kg-1. Participants will have mechanical ventilatory support and tidal volume will be set to 8- 10 ml/kg and minute breathing will be set to 16-26. The end tidal carbon dioxide will be kept between 35-40 mmHg. Anesthesia maintenance will be provided with a starting dose of sevoflurane 2% and IV remifentanil 0.05 mcg kg-1 min-1 with a flow of 3 Lt min-1, an Oxygen/air mixture. >20% increase in intraoperative heart rate will be evaluated as pain and remifentanil dose will be increased and the need for remifentanil used intraoperatively will be recorded.
Group ESP (n=30) participants will be given a lateral decubitus position under general anesthesia before the operation and sacral ESP block will be performed accompanied by ultrasound. Group C (n=30) participants who will undergo caudal block will also be given a lateral decubitus position and ultrasound-guided block will be performed.
After 15 minutes of block surgery will be initiated. All operations will be performed by the same experienced team with the same surgical technique.
Near the end of the operation, 15 mg kg-1 IV paracetamol will be given. At the end of the operation, the duration of operation will be recorded.
Pain scoring system Face, Legs, Activity, Cry, Consolability (FLACC) will be recorded in 5th and 30th minutes and 1st, 2nd, 4th, 6th, 12th, 24th hours.
At the end of the operation, the time when there is a need for analgesia will be evaluated as "the first need for analgesia (hour)".
Total amount of additional analgesia (oral paracetamol, mg), amount of rescue analgesia (oral ibuprofen, mg), participants' relative satisfaction (1-Not satisfied, 2-Satisfied, 3-Very satisfied) will be recorded.
Motor weakness, neurological deficit, urinary retention, nausea, vomiting, hypotension, bradycardia, itching, local anesthetic toxicity and bleeding that may occur will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Our research will be conducted in a single center as a prospective randomized controlled study. It was planned to include 60 patients from the ASA I-II pediatric patient group aged between 6 months and 7 years, who will undergo hypospadias surgery in our hospital between December 2022 and December 2023, and randomization will be done by closed envelope method. Two groups with sacral ESP and caudal block will be formed, each with 30 patients.
| Arm | Type | Receives |
|---|---|---|
| GROUP ESP | Active comparator | Procedure: SACRAL ESP AND CAUDAL BLOCKBefore the operation, under general anesthesia, group ESP (n=30) patients will be blocked with the sacral ESP block method. By giving the lateral decubitus position, the linear ultrasound probe will be placed in the sterilized area longitudinally on the midline of the sacrum. The erector spinae muscle and the sacral medial crest will be visualized. The 22 gauge, 50 mm needle will be advanced in the direction from cranial to caudal to reach the sacral crest. 0.25% bupivacaine from a dose of 1 mL kg-1 will be aspirated and injected every 2 mL under the erector spina muscle at the level of the median sacral crest at the level of the 4th sacral vertebra. (A test dose will be administered with 1 mL of saline.) |
| GROUP C | Sham comparator | Procedure: SACRAL ESP AND CAUDAL BLOCKGroup C (n=30) patients to whom caudal block will be applied will be placed in the lateral decubitus position and the linear ultrasound probe will be placed longitudinally in the sterilized area on the midline of the sacrum. A 2.5 cm 22 gauge needle will be inserted over the back skin of the sacral hiatus (located distal to the sacrum and formed by the two sacral cornua on its lateral edges) at a 90° position. The sacrococcygeal ligament will be crossed, the needle will be oriented approximately 25° and advanced approximately 2 to 3 mm to reach the sacral canal. After entering the sacral hiatus and confirming the location with negative aspiration method, 1 mL kg-1 0.25% bupivacaine will be injected by aspiration every 2 mL (test dose will be administered with 1 mL saline). |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesiology (ASA) I-II group
- 6 months to 7 years old
- Paediatric age group patients who will undergo hypospadias surgery under general anesthesia
Key exclusion criteria (10 listed)
- ASA III - IV patient group
- Patients who were operated on urgently
- Patient relatives who did not give consent
- Presence of local anesthetic allergy
- Presence of infection in the area to be blocked
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 |
|---|---|---|
| SACRAL ESP AND CAUDAL BLOCKApplication of ultrasound-guided sacral erector spinae plane (ESP) block or ultrasound-guided caudal block with 1mL/kg 0.25% bupivacaine (local anesthetic) to patients | Procedure or surgery | GROUP C, GROUP ESP |
Primary outcome
Duration of the analgesia
Time frame: 1 year
The duration that elapsed between block application and the patient\'s first analgesic requirement (if FLACC\>3) was evaluated and recorded as \'\'duration of analgesia (hours)\'\'
2 secondary outcomes
Evaluation of the analgesic effects of sacral ESP and caudal block with Face/ Leg/ Activity/ Cry/ Consolability (FLACC) scores in patients undergoing hypospadias surgery.
Time frame: 1 year
Morphine consumption
Time frame: 1 year
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 3 Oct 2024.
- Results publication: PubMed 31630465Mostafa SF, Abdelghany MS, Abdelraheem TM, Abu Elyazed MM. Ultrasound-guided erector spinae plane block for postoperative analgesia in pediatric patients undergoing splenectomy: A prospective randomized controlled trial. Paediatr Anaesth. 2019 Dec;29(12):1201-1207. doi: 10.1111/pan.13758. Epub 2019 Nov 8.
- Results publication: PubMed 31203111Aksu C, Gurkan Y. Sacral Erector Spinae Plane Block with longitudinal midline approach: Could it be the new era for pediatric postoperative analgesia? J Clin Anesth. 2020 Feb;59:38-39. doi: 10.1016/j.jclinane.2019.06.007. Epub 2019 Jun 13. No abstract available.
- Results publication: PubMed 21957982Kundra P, Yuvaraj K, Agrawal K, Krishnappa S, Kumar LT. Surgical outcome in children undergoing hypospadias repair under caudal epidural vs penile block. Paediatr Anaesth. 2012 Jul;22(7):707-12. doi: 10.1111/j.1460-9592.2011.03702.x. Epub 2011 Sep 29.
- Results publication: PubMed 32507565Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20.
- Results publication: PubMed 33585088Kaya C, Dost B, Tulgar S. Sacral Erector Spinae Plane Block Provides Surgical Anesthesia in Ambulatory Anorectal Surgery: Two Case Reports. Cureus. 2021 Jan 9;13(1):e12598. doi: 10.7759/cureus.12598.
- Results publication: PubMed 33178502Topdagi Yilmaz EP, Oral Ahiskalioglu E, Ahiskalioglu A, Tulgar S, Aydin ME, Kumtepe Y. A Novel Multimodal Treatment Method and Pilot Feasibility Study for Vaginismus: Initial Experience With the Combination of Sacral Erector Spinae Plane Block and Progressive Dilatation. Cureus. 2020 Oct 8;12(10):e10846. doi: 10.7759/cureus.10846.
- 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.
Sevgi KESİCİ principal investigator
Sisli Etfal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SACRAL ESP AND CAUDAL BLOCK in people with Post Operative Pain and Hypospadias, run by Sisli Hamidiye Etfal Training and Research 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 3 inclusion and 10 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 3 Oct 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. 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?
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?
Duration of the analgesia (time frame: 1 year). 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 NCT05632536, 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 3 Oct 2024.