Post Operative PainNCT05633173
Effects of Erector Spinae Plane and Caudal Block on Postoperative Stress Response
A study testing Ultrasound-guided erector spinae plan block and Ultrasound-guided caudal block in people with Post Operative Pain and Stress Response, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Inguinal hernia surgery is the most common practice of pediatric surgeons in their clinical practice. As these operations are usually day case procedures, maintaining adequate analgesia is an important component of perioperative care and ERAS protocols. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Post Operative Pain, Stress Response, Erector Spinae Plane Block
- What is being tested?
- Ultrasound-guided erector spinae plan block and Ultrasound-guided caudal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2022to 5 Mar 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA (American Society of Anesthesiologists) class I-II patients
- Patients aged 1 - 6 years
- Patients who will undergo unilateral inguinal hernia surgery
Who cannot join
- ASA III - IV patients
- Emergency surgery patients
- Children of parents who did not give consent
- Patients with chronic pain
- Local anesthetic allergy
- Infection in the block area
Show all 12Show fewer
- Coagulopathy
- Increased intracranial pressure
- Neurological deficit
- Severe organ failure
- Mental retardation
- Anatomical deformities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, Sisli
About this study
Official title: Comparison of the Effects of Erector Spinae Plane Block and Caudal Block on Postoperative Analgesia and Stress Response in Pediatric Patients Undergoing Inguinal Hernia Surgery, Prospective Randomized Trial
Inguinal hernia surgery is the most common practice of pediatric surgeons in their clinical practice. As these operations are usually day case procedures, maintaining adequate analgesia is an important component of perioperative care and ERAS protocols. Caudal block, which is one of the analgesic methods used for postoperative pain, is the most frequently used in inguinal hernia surgery and its effectiveness has been proven. Erector spina plane block, which is easy to apply and has a low risk of side effects, is another tool used in the treatment of postoperative pain after inguinal hernia surgery. These are the procedures that are routinely applied in our center with the aim of intraoperative and postoperative effective analgesia.
Read the detailed description
Surgery is a common medical procedure that exposes children to pain. More than 85% of children experience clinically significant pain after surgery and 63% after discharge. Postoperative pain management in pediatric ages also plays a role in future pain perception and chronic pain development. It has been reported that acute postoperative pain progresses to chronic pain in 20% of children undergoing major surgery. It is also known that children with inadequate pain management experience a decline in immune and neuroendocrine functions later in life.
Inguinal hernia surgery is one of the most frequently performed elective surgeries in pediatric surgery practice and often performed in early childhood. The presence of postoperative pain delays the return to normal activity and prolongs the time to discharge. Ideal pain management should provide complete pain relief without interfering with the child's daily life, and the techniques and drugs used in the treatment should cause as few side effects as possible. Opioid and non-opioid analgesics have side effects such as itching, vomiting, delay in gastrointestinal function, urinary retention, respiratory depression, liver failure, antithrombotic effect, delayed wound healing, renal and gastrointestinal toxicity that limit their use in children.
In recent years, multimodal analgesia in which non-opioid analgesics are combined with small doses of opioids or regional blocks is increasingly preferred. Caudal block, one of the regional blocks, has been widely used in pediatric surgery for many years due to its proven effectiveness in postoperative analgesia. In addition, with the widespread use of ultrasound, many body blocks have become used with high success rates in both upper and lower abdominal surgeries in postoperative pain management. Erector spina plane block (ESPB), defined by Forrero et al. in 2016, is an interfacial plane block that is a simpler and safer alternative to thoracic epidural or paravertebral block. Its use for analgesia is common in adults in various surgeries, and its use in pediatric surgeries is also becoming widespread. In a review published in 2019, it was reported that only 23 of 242 ESPB cases were children. Clinical studies of ESPB applied in pediatric patients are not sufficient in the literature.
Tissue damage caused by surgery or trauma brings hormonal, metabolic and hemodynamic changes. It is known that post-surgical stress response causes major changes in the cardiovascular and respiratory systems. Controlling postoperative pain is associated with decreased stress hormone response. The scales used in the evaluation of postoperative pain in pediatric patients are insufficient due to the inability of the patients to express themselves and their high anxiety coefficients. For this reason, it has been suggested that stress hormone levels may be an objective method for determining the analgesic efficacy of the anesthetic technique. Early mobilization and postoperative pain management gain importance in inguinal hernia surgery, since they are outpatient surgical procedures.
- Being tested
- Ultrasound-guided erector spinae plan block, Ultrasound-guided caudal block
- Keywords
- Pediatric regional anesthesia, Erector spina plane block, Caudal block, Surgical stress hormone
- Medical subject headings
- Pain, Postoperative, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided erector spinae plan blockProcedure or surgery
Ultrasound-guided erector spina plan block was performed for patients in group E for postoperative analgesia. The patients were placed in the lateral decubitus position and the linear ultrasound probe was placed longitudinally into the sterilized area 1-2 cm lateral to the spinous process of the L1 vertebra. After visualizing the erector spina muscle and the transverse process, the transverse process was reached by pushing forward the 22 gauge, 50 mm needle in the direction from cranial to caudal. Hydrodissection was performed with 1 ml of saline for confirmation. 0.5 mL kg-1 dose of 0.25% bupivacaine was injected under the erector spina muscle at the level of the 1st lumbar vertebra by aspiration every 2 mL.
Ultrasound-guided caudal blockProcedure or surgery
The patients in group C underwent ultrasound guided caudal block for postoperative analgesia. By placing the patients in the lateral decubitus position, the linear ultrasound probe was placed longitudinally on the sterilized area on the midline of the sacrum, and access was provided with a 2.5 cm 22 gauge needle on the dorsal skin of the sacral hiatus at a 90° position. The sacrococcygeal ligament was crossed, the needle was oriented approximately 25° and advanced approximately 2 to 3 mm to reach the sacral canal. When it was understood that the sacral hiatus had been entered, 0.5 mL kg-1 0.25% bupivacaine was injected by aspirating every 2 mL after the location was confirmed with the negative aspiration method.
| Study group | Role | What they receive |
|---|---|---|
| Group E | Experimental | Ultrasound-guided erector spina plan block was performed for patients in group E for postoperative analgesia. The patients were placed in the lateral decubitus position and the linear ultrasound probe was placed longitudinally into the sterilized area 1-2 cm lateral to the spinous process of the L1 vertebra. After visualizing the erector spina muscle and the transverse process, the transverse process was reached by pushing forward the 22 gauge, 50 mm needle in the direction from cranial to caudal. Hydrodissection was performed with 1 ml of saline for confirmation. 0.5 mL kg-1 dose of 0.25% bupivacaine was injected under the erector spina muscle at the level of the 1st lumbar vertebra by aspiration every 2 mL. Receives: Procedure: Ultrasound-guided erector spinae plan block |
| Group C | Active comparator | The patients in group C underwent ultrasound guided caudal block for postoperative analgesia. By placing the patients in the lateral decubitus position, the linear ultrasound probe was placed longitudinally on the sterilized area on the midline of the sacrum, and access was provided with a 2.5 cm 22 gauge needle on the dorsal skin of the sacral hiatus at a 90° position. The sacrococcygeal ligament was crossed, the needle was oriented approximately 25° and advanced approximately 2 to 3 mm to reach the sacral canal. When it was understood that the sacral hiatus had been entered, 0.5 mL kg-1 0.25% bupivacaine was injected by aspirating every 2 mL after the location was confirmed with the negative aspiration method. Receives: Procedure: Ultrasound-guided caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress Response
serum concentration of Cortisol, serum concentration of Prolactin
Measured: 3 hours
Secondary outcomes (4)
FLACC scores
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale. FLACC is abehavioral pain assessment scale used for nonverbal or preverbal patients who areunable to self-report their level of pain. Pain is assessed through observation of 5categories including face, legs, activity, cry, and consolability. The increase in thepain felt by the patient also increases the fl acc score. Each category is scored onthe 0-2 scale which results in a total score of 0-10.
Measured: 24 hours
Analgesic Consumption
The total amount of analgesic in the first 24 hours
Measured: 24 hours
Analgesia Time
The time of first analgesic need
Measured: 24 hours
Complications
Hypotension, bradycardia, vomiting, itching
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 posted1 Dec 2022
- Study start6 Dec 2022
- Primary completion25 Feb 2023
- Study completion5 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- The patients to be included in the study were randomized into two groups, Group E and C, using the closed envelope method in the preoperative period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Uyanıkoğlu, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Ayşe Surhan ÇINAR, Study chair, Sisli Hamidiye Etfal Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633173
- Sponsor's protocol ID
- 7931
- Status last verified
- Mar 2023
- First submitted
- 17 Nov 2022
- Last updated
- 24 Mar 2023
- 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 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Erector Spinae Plane Block and Caudal Block on Postoperative Analgesia and Stress Response in Pediatric Patients Undergoing Inguinal Hernia Surgery, Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05633173
- Acronym / sponsor ID
- 7931
- Keywords
- Pediatric regional anesthesia, Erector spina plane block, Caudal block, Surgical stress hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 1 Dec 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.
Inguinal hernia surgery is the most common practice of pediatric surgeons in their clinical practice. As these operations are usually day case procedures, maintaining adequate analgesia is an important component of perioperative care and ERAS protocols. Caudal block, which is one of the analgesic methods used for postoperative pain, is the most frequently used in inguinal hernia surgery and its effectiveness has been proven. Erector spina plane block, which is easy to apply and has a low risk of side effects, is another tool used in the treatment of postoperative pain after inguinal hernia surgery. These are the procedures that are routinely applied in our center with the aim of intraoperative and postoperative effective analgesia.
Detailed description
Surgery is a common medical procedure that exposes children to pain. More than 85% of children experience clinically significant pain after surgery and 63% after discharge. Postoperative pain management in pediatric ages also plays a role in future pain perception and chronic pain development. It has been reported that acute postoperative pain progresses to chronic pain in 20% of children undergoing major surgery. It is also known that children with inadequate pain management experience a decline in immune and neuroendocrine functions later in life.
Inguinal hernia surgery is one of the most frequently performed elective surgeries in pediatric surgery practice and often performed in early childhood. The presence of postoperative pain delays the return to normal activity and prolongs the time to discharge. Ideal pain management should provide complete pain relief without interfering with the child's daily life, and the techniques and drugs used in the treatment should cause as few side effects as possible. Opioid and non-opioid analgesics have side effects such as itching, vomiting, delay in gastrointestinal function, urinary retention, respiratory depression, liver failure, antithrombotic effect, delayed wound healing, renal and gastrointestinal toxicity that limit their use in children.
In recent years, multimodal analgesia in which non-opioid analgesics are combined with small doses of opioids or regional blocks is increasingly preferred. Caudal block, one of the regional blocks, has been widely used in pediatric surgery for many years due to its proven effectiveness in postoperative analgesia. In addition, with the widespread use of ultrasound, many body blocks have become used with high success rates in both upper and lower abdominal surgeries in postoperative pain management. Erector spina plane block (ESPB), defined by Forrero et al. in 2016, is an interfacial plane block that is a simpler and safer alternative to thoracic epidural or paravertebral block. Its use for analgesia is common in adults in various surgeries, and its use in pediatric surgeries is also becoming widespread. In a review published in 2019, it was reported that only 23 of 242 ESPB cases were children. Clinical studies of ESPB applied in pediatric patients are not sufficient in the literature.
Tissue damage caused by surgery or trauma brings hormonal, metabolic and hemodynamic changes. It is known that post-surgical stress response causes major changes in the cardiovascular and respiratory systems. Controlling postoperative pain is associated with decreased stress hormone response. The scales used in the evaluation of postoperative pain in pediatric patients are insufficient due to the inability of the patients to express themselves and their high anxiety coefficients. For this reason, it has been suggested that stress hormone levels may be an objective method for determining the analgesic efficacy of the anesthetic technique. Early mobilization and postoperative pain management gain importance in inguinal hernia surgery, since they are outpatient surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The patients to be included in the study were randomized into two groups, Group E and C, using the closed envelope method in the preoperative period.
| Arm | Type | Receives |
|---|---|---|
| Group E | Experimental | Procedure: Ultrasound-guided erector spinae plan blockUltrasound-guided erector spina plan block was performed for patients in group E for postoperative analgesia. The patients were placed in the lateral decubitus position and the linear ultrasound probe was placed longitudinally into the sterilized area 1-2 cm lateral to the spinous process of the L1 vertebra. After visualizing the erector spina muscle and the transverse process, the transverse process was reached by pushing forward the 22 gauge, 50 mm needle in the direction from cranial to caudal. Hydrodissection was performed with 1 ml of saline for confirmation. 0.5 mL kg-1 dose of 0.25% bupivacaine was injected under the erector spina muscle at the level of the 1st lumbar vertebra by aspiration every 2 mL. |
| Group C | Active comparator | Procedure: Ultrasound-guided caudal blockThe patients in group C underwent ultrasound guided caudal block for postoperative analgesia. By placing the patients in the lateral decubitus position, the linear ultrasound probe was placed longitudinally on the sterilized area on the midline of the sacrum, and access was provided with a 2.5 cm 22 gauge needle on the dorsal skin of the sacral hiatus at a 90° position. The sacrococcygeal ligament was crossed, the needle was oriented approximately 25° and advanced approximately 2 to 3 mm to reach the sacral canal. When it was understood that the sacral hiatus had been entered, 0.5 mL kg-1 0.25% bupivacaine was injected by aspirating every 2 mL after the location was confirmed with the negative aspiration method. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA (American Society of Anesthesiologists) class I-II patients
- Patients aged 1 - 6 years
- Patients who will undergo unilateral inguinal hernia surgery
Key exclusion criteria (12 listed)
- ASA III - IV patients
- Emergency surgery patients
- Children of parents who did not give consent
- Patients with chronic pain
- Local anesthetic allergy
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 |
|---|---|---|
| Ultrasound-guided erector spinae plan blockUltrasound-guided erector spina plan block was performed for patients in group E for postoperative analgesia. The patients were placed in the lateral decubitus position and the linear ultrasound probe was placed longitudinally into the sterilized area 1-2 cm lateral to the spinous process of the L1 vertebra. After visualizing the erector spina muscle and the transverse process, the transverse process was reached by pushing forward the 22 gauge, 50 mm needle in the direction from cranial to caudal. Hydrodissection was performed with 1 ml of saline for confirmation. 0.5 mL kg-1 dose of 0.25% bupivacaine was injected under the erector spina muscle at the level of the 1st lumbar vertebra by aspiration every 2 mL. | Procedure or surgery | Group E |
| Ultrasound-guided caudal blockThe patients in group C underwent ultrasound guided caudal block for postoperative analgesia. By placing the patients in the lateral decubitus position, the linear ultrasound probe was placed longitudinally on the sterilized area on the midline of the sacrum, and access was provided with a 2.5 cm 22 gauge needle on the dorsal skin of the sacral hiatus at a 90° position. The sacrococcygeal ligament was crossed, the needle was oriented approximately 25° and advanced approximately 2 to 3 mm to reach the sacral canal. When it was understood that the sacral hiatus had been entered, 0.5 mL kg-1 0.25% bupivacaine was injected by aspirating every 2 mL after the location was confirmed with the negative aspiration method. | Procedure or surgery | Group C |
Primary outcome
Stress Response
Time frame: 3 hours
serum concentration of Cortisol, serum concentration of Prolactin
4 secondary outcomes
FLACC scores
Time frame: 24 hours
Analgesic Consumption
Time frame: 24 hours
Analgesia Time
Time frame: 24 hours
Complications
Time frame: 24 hours
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 Mar 2023.
- 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.
Ayşe Surhan ÇINAR study chair
Sisli Hamidiye Etfal Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided erector spinae plan block and Ultrasound-guided caudal block in people with Post Operative Pain and Stress Response, 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 12 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 Mar 2023. 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?
Stress Response (time frame: 3 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 24 Mar 2023.