Postoperative Pain, AcuteNCT05729308
Comparative Study Between Caudal Epidural Block and Bilateral Erector Spinae Plane Block in Lumbosacral Spine Surgeries.
A study testing caudal epidural block, bilateral erector spinae plane block and general anesthesia with intravenous analgesia. in people with Postoperative Pain, Acute, run by Ain Shams University at 1 site in Egypt.
Trial summary
It is widely believed that major lumbosacral spine surgeries are associated with severe postoperative pain that may delay the functional recovery of the patient. Caudal epidural injection (CE) has an important role in providing effective pain relief post lumbosacral spine surgeries by blocking sensory input at the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- caudal epidural block, bilateral erector spinae plane block and general anesthesia with intravenous analgesia.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2023to Mar 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for lumbosacral spine surgery level from L4 to S1.
- American Society of Anesthesiologists classification (ASA) class I or II.
Who cannot join
- Refusal of procedure or participation in the study.
- American Society of Anesthesiologists classification (ASA) class III or IV.
- Coagulation disorders (platelets count < 100,000; International normalized ratio >1.4; Patient control time< 60%) and coagulopathies.
- Skin lesion or infection at the injection site.
- Known allergy to any of the medications used.
- Chronic opioid users.
- Patients with pre-operative opioid consumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Caudal Epidural Block and Bilateral Erector Spinae Plane Block in Adult Patients Undergoing Lumbosacral Spine Surgeries.
It is widely believed that major lumbosacral spine surgeries are associated with severe postoperative pain that may delay the functional recovery of the patient. Caudal epidural injection (CE) has an important role in providing effective pain relief post lumbosacral spine surgeries by blocking sensory input at the level of the spinal cord. Erector Spinae Plane Block (ESPB) is a relatively new technique of trunk fascial block which was introduced in 2016. Reports showed that ESPB significantly relieved postoperative pain in patients with lumbosacral spine surgery, reducing the use of analgesics.The overall benefit of intravenous (IV) analgesia versus pre-emptive analgesia by caudal epidural or erector spinae block is still controversial.
The aim of this study is to compare the pre-emptive analgesic effect of bilateral erector spinae plane block versus Caudal epidural analgesia versus the conventional intravenous analgesia in adult patients undergoing lumbosacral spine surgeries under general anesthesia.
Read the detailed description
78 Participants undergoing lumbosacral spine surgeries who met the inclusion criteria will be divided into three groups each group contains 26 patients:
Group (CE): Patients receiving caudal epidural block. Group (ESP): Patients receiving bilateral erector spinae plane block. Group (C): Control group, patients receiving general anesthesia with intravenous analgesia.
- Study procedures:
- Routine preoperative assessment will be done for all the participants.
- All participants will be fasting before the procedure not less than 6 hours.
- General anesthesia will be induced with midazolam (0.05mg/kg), propofol (1.5-2mg/kg), fentanyl (1-2μg/kg) and atracurium (0.5mg/kg),
- Tracheal intubation will be performed. After induction, general anesthesia will be maintained with a volatile anesthetic agent (0.9:1.2% isoflurane) and controlled ventilation with atracurium every 20 mins (0.1 mg/kg).
- Standard monitoring of mean arterial blood pressure (MAP), heart rate (HR) and peripheral pulse oximeter (SPO2) value will be monitored at time of induction (time 0) and every 10 minutes till the end of the procedure.
Group (CE): Caudal epidural group The patient will be positioned in prone position, sterilized from the iliac crest margin to the lower buttock. Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound guidance using SonoSite M Turbo(USA).The scanning probe is the linear multi-frequency 6-13 megahertz transducer (L25 x 6-13 megahertz linear array)that is covered in sterile plastic bag.Short axis (transverse view) is used first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An 18-gauge epidural needle (length 90 mm) is used for direct puncture of sacrococcygeal membrane out of plane then the probe is rotated to long axis (longitudinal view) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.25% bupivacaine will expand the epidural space.
Group (ES): Erector spinae group The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of T12. A curvilinear high-frequency ultrasound transducer will be placed sagittal 3 cm lateral to T12 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 15 mL of 0.25% bupivacaine will be injected. The procedure will be repeated following the same steps on the other side.
Group(C): General anesthesia with conventional intravenous analgesia.
- Multimodal therapy with acetaminophen, and nonsteroidal anti-inflammatory drugs (NSAIDs) will be used.
- Vital data will be monitored as mentioned Intraoperatively, if the pulse rate and/or mean blood pressure increased above 20% of the baseline, IV fentanyl will be administered as an incremental dose of 50 µg.
- The patients will be monitored for heart rate and blood pressure at regular 10-minute intervals. If blood pressure decreased more than 20% from baseline, then the patient will receive 500 mL saline infusion; if no response is seen, then 5 mg ephedrine will be administered. If heart rate decreased to 45 beats per minute, an IV injection of 0.1 mg /kg atropine will be administered.
- After completion of the surgical procedure, patient will be in supine position, isoflurane will be discontinued and fresh gas flow will be increased and any residual neuromuscular blockade will be reversed by I.V neostigmine 50 μg/kg (to a maximum of 5 mg) plus atropine 10-20 μg/kg.
- Any blood and secretions in the pharynx will be carefully suctioned. Tracheal extubation will be performed when the patient regained consciousness, has sufficient spontaneous breathing, intact gag reflex, purposeful movement, and spontaneous eye opening.
- After extubation in the three groups, the patients will be transferred to the postanesthesia care unit and will be monitored as mentioned above.
- The visual analog score (VAS) is a validated, subjective measure for acute pain. Scores are recorded by making a handwritten mark on a 10 cm line that represents a continuum between "no pain" and "worst pain".
- VAS score will be assessed at 15 \& 30 mins, then at 2, 6, 12, 24 hours post-operatively.
- Rescue pain analgesia will be given postoperatively for visual analogue scale (VAS)≥4 by nalbuphine hydrochloride (Nalufin)10-20 mg/70kg IV q3-6hr on demand; individual dose not to exceed 20 mg). VAS will be reassessed 15 minutes later to any post analgesic injection.
- Conditions
- Postoperative Pain, Acute
- Being tested
- caudal epidural block, bilateral erector spinae plane block, general anesthesia with intravenous analgesia.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal epidural blockProcedure or surgery
The patient will be positioned in prone position, sterilized from the iliac crest margin to the lower buttock. Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound guidance using SonoSite M Turbo(USA).The scanning probe is the linear multi-frequency 6-13 MHz transducer (L25 x 6-13 megahertz linear array)that is covered in sterile plastic bag.Short axis (transverse view) is used first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An 18-gauge epidural needle (length 90 mm) is used for direct puncture of sacrococcygeal membrane out of plane then the probe is rotated to long axis (longitudinal view) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.25% bupivacaine will expand the epidural space
bilateral erector spinae plane blockProcedure or surgery
The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of T12. A curvilinear high-frequency ultrasound transducer will be placed sagittal 3 cm lateral to T12 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 15 mL of 0.25% bupivacaine will be injected. The procedure will be repeated following the same steps on the other side
general anesthesia with intravenous analgesia.Procedure or surgery
- Multimodal therapy with acetaminophen, and nonsteroidal anti-inflammatory drugs (NSAIDs) will be used.
- Vital data will be monitored as mentioned Intraoperatively, if the pulse rate and/or mean blood pressure increased above 20% of the baseline, IV fentanyl will be administered as an incremental dose of 50 µg.
- The patients will be monitored for heart rate and blood pressure at regular 10-minute intervals. If blood pressure decreased more than 20% from baseline, then the patient will receive 500 mL saline infusion; if no response is seen, then 5 mg ephedrine will be administered. If heart rate decreased to 45 beats per minute, an IV injection of 0.1 mg /kg atropine will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Group (CE): Patients receiving caudal epidural block | Active comparator | Not described Receives: Procedure: caudal epidural block |
| Group (ESP): Patients receiving bilateral erector spinae plane block. | Active comparator | Not described Receives: Procedure: bilateral erector spinae plane block |
| Group (C): Control group, patients receiving general anesthesia with intravenous analgesia. | Active comparator | Not described Receives: Procedure: general anesthesia with intravenous analgesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesia
using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: immediately postoperative
postoperative analgesia
using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: 2 hours postoperative
postoperative analgesia
using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: 6 hours postoperative
postoperative analgesia
using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: 12 hours postoperative
postoperative analgesia
using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: 24 hours postoperative
Secondary outcomes (7)
intraoperative mean arterial blood pressure
measured by non invasive blood pressure monitoring
Measured: every 10 minutes intraoperative till end of surgery
intraoperative heart rate
measured by twelve leads electrocardiogram
Measured: every 10 minutes intraoperative till end of surgery
postoperative first rescue analgesia time
Measured: during the 24 hours postoperative
Surgical field bleeding.
using Fromme score assessed by the surgeon 6-point scale
Endoscopic surgical field grading system
Grade Assessment 0 No bleeding (cadaveric conditions)
- Slight bleeding, no suctioning required
- Slight bleeding, occasional suctioning required
- Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed
- Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed
- Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible
Measured: from the start till the end of the operation
Number of participant with postoperative nausea
Measured: during the 24 hours postoperative
Number of participant with postoperative vomiting
Measured: during the 24 hours postoperative
Number of participant with postoperative urinary retention
Measured: during the 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729308
- Sponsor's protocol ID
- md 335/2022
- Status last verified
- Feb 2023
- First submitted
- 28 Jan 2023
- Last updated
- 15 Feb 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 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Caudal Epidural Block and Bilateral Erector Spinae Plane Block in Adult Patients Undergoing Lumbosacral Spine Surgeries.
- ClinicalTrials.gov ID
- NCT05729308
- Acronym / sponsor ID
- md 335/2022
- Conditions
- Postoperative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 15 Feb 2023 (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.
It is widely believed that major lumbosacral spine surgeries are associated with severe postoperative pain that may delay the functional recovery of the patient. Caudal epidural injection (CE) has an important role in providing effective pain relief post lumbosacral spine surgeries by blocking sensory input at the level of the spinal cord. Erector Spinae Plane Block (ESPB) is a relatively new technique of trunk fascial block which was introduced in 2016. Reports showed that ESPB significantly relieved postoperative pain in patients with lumbosacral spine surgery, reducing the use of analgesics.The overall benefit of intravenous (IV) analgesia versus pre-emptive analgesia by caudal epidural or erector spinae block is still controversial.
The aim of this study is to compare the pre-emptive analgesic effect of bilateral erector spinae plane block versus Caudal epidural analgesia versus the conventional intravenous analgesia in adult patients undergoing lumbosacral spine surgeries under general anesthesia.
Detailed description
78 Participants undergoing lumbosacral spine surgeries who met the inclusion criteria will be divided into three groups each group contains 26 patients:
Group (CE): Patients receiving caudal epidural block. Group (ESP): Patients receiving bilateral erector spinae plane block. Group (C): Control group, patients receiving general anesthesia with intravenous analgesia.
- Study procedures:
- Routine preoperative assessment will be done for all the participants.
- All participants will be fasting before the procedure not less than 6 hours.
- General anesthesia will be induced with midazolam (0.05mg/kg), propofol (1.5-2mg/kg), fentanyl (1-2μg/kg) and atracurium (0.5mg/kg),
- Tracheal intubation will be performed. After induction, general anesthesia will be maintained with a volatile anesthetic agent (0.9:1.2% isoflurane) and controlled ventilation with atracurium every 20 mins (0.1 mg/kg).
- Standard monitoring of mean arterial blood pressure (MAP), heart rate (HR) and peripheral pulse oximeter (SPO2) value will be monitored at time of induction (time 0) and every 10 minutes till the end of the procedure.
Group (CE): Caudal epidural group The patient will be positioned in prone position, sterilized from the iliac crest margin to the lower buttock. Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound guidance using SonoSite M Turbo(USA).The scanning probe is the linear multi-frequency 6-13 megahertz transducer (L25 x 6-13 megahertz linear array)that is covered in sterile plastic bag.Short axis (transverse view) is used first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An 18-gauge epidural needle (length 90 mm) is used for direct puncture of sacrococcygeal membrane out of plane then the probe is rotated to long axis (longitudinal view) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.25% bupivacaine will expand the epidural space.
Group (ES): Erector spinae group The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of T12. A curvilinear high-frequency ultrasound transducer will be placed sagittal 3 cm lateral to T12 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 15 mL of 0.25% bupivacaine will be injected. The procedure will be repeated following the same steps on the other side.
Group(C): General anesthesia with conventional intravenous analgesia.
- Multimodal therapy with acetaminophen, and nonsteroidal anti-inflammatory drugs (NSAIDs) will be used.
- Vital data will be monitored as mentioned Intraoperatively, if the pulse rate and/or mean blood pressure increased above 20% of the baseline, IV fentanyl will be administered as an incremental dose of 50 µg.
- The patients will be monitored for heart rate and blood pressure at regular 10-minute intervals. If blood pressure decreased more than 20% from baseline, then the patient will receive 500 mL saline infusion; if no response is seen, then 5 mg ephedrine will be administered. If heart rate decreased to 45 beats per minute, an IV injection of 0.1 mg /kg atropine will be administered.
- After completion of the surgical procedure, patient will be in supine position, isoflurane will be discontinued and fresh gas flow will be increased and any residual neuromuscular blockade will be reversed by I.V neostigmine 50 μg/kg (to a maximum of 5 mg) plus atropine 10-20 μg/kg.
- Any blood and secretions in the pharynx will be carefully suctioned. Tracheal extubation will be performed when the patient regained consciousness, has sufficient spontaneous breathing, intact gag reflex, purposeful movement, and spontaneous eye opening.
- After extubation in the three groups, the patients will be transferred to the postanesthesia care unit and will be monitored as mentioned above.
- The visual analog score (VAS) is a validated, subjective measure for acute pain. Scores are recorded by making a handwritten mark on a 10 cm line that represents a continuum between "no pain" and "worst pain".
- VAS score will be assessed at 15 \& 30 mins, then at 2, 6, 12, 24 hours post-operatively.
- Rescue pain analgesia will be given postoperatively for visual analogue scale (VAS)≥4 by nalbuphine hydrochloride (Nalufin)10-20 mg/70kg IV q3-6hr on demand; individual dose not to exceed 20 mg). VAS will be reassessed 15 minutes later to any post analgesic injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (CE): Patients receiving caudal epidural block | Active comparator | Procedure: caudal epidural block |
| Group (ESP): Patients receiving bilateral erector spinae plane block. | Active comparator | Procedure: bilateral erector spinae plane block |
| Group (C): Control group, patients receiving general anesthesia with intravenous analgesia. | Active comparator | Procedure: general anesthesia with intravenous analgesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for lumbosacral spine surgery level from L4 to S1.
- American Society of Anesthesiologists classification (ASA) class I or II.
Key exclusion criteria (7 listed)
- Refusal of procedure or participation in the study.
- American Society of Anesthesiologists classification (ASA) class III or IV.
- Coagulation disorders (platelets count < 100,000; International normalized ratio >1.4; Patient control time< 60%) and coagulopathies.
- Skin lesion or infection at the injection site.
- Known allergy to any of the medications used.
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 |
|---|---|---|
| caudal epidural blockThe patient will be positioned in prone position, sterilized from the iliac crest margin to the lower buttock. Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound guidance using SonoSite M Turbo(USA).The scanning probe is the linear multi-frequency 6-13 MHz transducer (L25 x 6-13 megahertz linear array)that is covered in sterile plastic bag.Short axis (transverse view) is used first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An 18-gauge epidural needle (length 90 mm) is used for direct puncture of sacrococcygeal membrane out of plane then the probe is rotated to long axis (longitudinal view) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.25% bupivacaine will expand the epidural space | Procedure or surgery | Group (CE): Patients receiving caudal epidural block |
| bilateral erector spinae plane blockThe patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of T12. A curvilinear high-frequency ultrasound transducer will be placed sagittal 3 cm lateral to T12 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 15 mL of 0.25% bupivacaine will be injected. The procedure will be repeated following the same steps on the other side | Procedure or surgery | Group (ESP): Patients receiving bilateral erector spinae plane block. |
| general anesthesia with intravenous analgesia.* Multimodal therapy with acetaminophen, and nonsteroidal anti-inflammatory drugs (NSAIDs) will be used. * Vital data will be monitored as mentioned Intraoperatively, if the pulse rate and/or mean blood pressure increased above 20% of the baseline, IV fentanyl will be administered as an incremental dose of 50 µg. * The patients will be monitored for heart rate and blood pressure at regular 10-minute intervals. If blood pressure decreased more than 20% from baseline, then the patient will receive 500 mL saline infusion; if no response is seen, then 5 mg ephedrine will be administered. If heart rate decreased to 45 beats per minute, an IV injection of 0.1 mg /kg atropine will be administered. | Procedure or surgery | Group (C): Control group, patients receiving general anesthesia with intravenous analgesia. |
Primary outcome
postoperative analgesia
Time frame: immediately postoperative
using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
postoperative analgesia
Time frame: 2 hours postoperative
using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
postoperative analgesia
Time frame: 6 hours postoperative
using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
postoperative analgesia
Time frame: 12 hours postoperative
using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
postoperative analgesia
Time frame: 24 hours postoperative
using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
7 secondary outcomes
intraoperative mean arterial blood pressure
Time frame: every 10 minutes intraoperative till end of surgery
intraoperative heart rate
Time frame: every 10 minutes intraoperative till end of surgery
postoperative first rescue analgesia time
Time frame: during the 24 hours postoperative
Surgical field bleeding.
Time frame: from the start till the end of the operation
Number of participant with postoperative nausea
Time frame: during the 24 hours postoperative
Number of participant with postoperative vomiting
Time frame: during the 24 hours postoperative
Number of participant with postoperative urinary retention
Time frame: during the 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 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.
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?
A study testing caudal epidural block, bilateral erector spinae plane block and general anesthesia with intravenous analgesia. in people with Postoperative Pain, Acute, run by Ain Shams University at 1 site in Egypt.
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 7 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: status not confirmed, as of the sponsor's last update on 15 Feb 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 Egypt. 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?
Results are not available in the source record.
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?
postoperative analgesia (time frame: immediately postoperative). The study lists 5 primary outcomes in all. 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 15 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.