HysterectomyNCT04382274
Quadratus Lumborum Block Versus Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve Blocks for Postoperative Analgesia Following Total Abdominal Hysterectomy
A study testing Quadratus Lumborum Block and Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve blocks in people with Hysterectomy, run by Tanta University at 1 site in Egypt.
Trial summary
Multimodal pain management program is needed to control severe pain after abdominal hysterectomy which is considered as one of the major abdominal surgeries. Opioids (which are the analgesic of choice) have many adverse effects such as sedation, nausea, and vomiting. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Quadratus Lumborum Block and Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve blocks
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2020to 1 Nov 2020
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1.60 female patients 2. aged 45-60 years 3. ASA Physical Status Class I and II 4. scheduled for abdominal hysterectomy
Who cannot join
- Patients had infection at injection site
- Allergy to local anesthetics
- Coagulation disorders
- Severe obesity
- Physical or mental diseases which could interfere with the evaluation of pain scores
- Kidney failure or liver failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quadratus Lumborum Block Versus Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve Blocks for Postoperative Analgesia Following Total Abdominal Hysterectomy: A Randomized Controlled Trial
Multimodal pain management program is needed to control severe pain after abdominal hysterectomy which is considered as one of the major abdominal surgeries. Opioids (which are the analgesic of choice) have many adverse effects such as sedation, nausea, and vomiting. Hence, different methods are needed to control pain and decrease opioid consumption and its side effects.
Transversus abdominis plane (TAP) block blocks the sensory afferent nerves run between the abdominal muscles and controls postoperative incisional pain.
Read more
Blanco was the first who described the quadratus lumborum block (QLB). Somatic pain after upper and lower abdominal surgery can be controlled by QLB. QLB can be performed for all generations (adult, pediatrics, and pregnant).
QLB is considered to be an easy technique to learn as it is easy to get the key sonoanatomic markers for QLB. The novice can learn this block after only a few performance of the procedure. QLB produces effective postoperative analgesia after abdominal surgery, laparoscopic surgery, anterior abdominal wall surgery, and hip and femur surgery. The analgesic effect of QLB covers 24-48 h. While some authors inserted catheter for continuous infusion of the local anesthetic drug to extend the duration of postoperative analgesia, others added dexamethasone to local anesthetic to extend the effect of local anesthetic drugs.
Ultrasound (US)-guided Ilioinguinal and Iliohypogastric nerve and TAP block have been established as analgesic adjuncts for post hernia repair pain management, under general anaesthesia, neuraxial, MAC and infiltration techniques.
US-guided technique of blocking Ilioinguinal and Iliohypogastric nerves have higher success rate compared to conventional technique. TAP block provides analgesia to the parietal peritoneum and skin of the abdomen in infra-umbilical surgeries. Few cadaveric studies showed good analgesic effect in the region between T10 and L1 following a single posterior TAP injection.
Read the detailed description
All patients will be assessed preoperatively by history taking, physical examination, and laboratory evaluation. On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, pulse oximetry, and capnography will be applied. Baseline parameters such as systolic blood pressure, diastolic blood pressure, mean blood pressure, heart rate (HR), and arterial oxygen saturation will be also recorded.
Intravenous (IV) line will be inserted and IV fluid will be started. For both groups, general anesthesia will be induced with IV injection of fentanyl (1 µg/kg) (Sunny Pharmaceutical, Egypt) and propofol (2mg/kg) (AstraZeneca, UK), and then, atracurium (0.5 mg/kg) (GlaxoSmithKline, UK) will be injected for endotracheal intubation.
Mechanical ventilation will be maintained to keep the end-expiratory CO2 values between 34 and 36 mmHg. Anesthesia will be continued with isoflurane 1%-2% in 100% O2. Incremental dose of atracurium (0.1 mg/kg) will be given every 30 min or when needed.
After endotracheal intubation and before the start of the surgery. A computer system will be used for randomization by creating a list of number each number referred to one of the two groups. Block randomization will be used to ensure equality of the groups. Each number will be sealed in an opaque envelope. Then, each patient will be asked to choose one of the envelopes and give to an anesthesiologist who compared it to the computer-generated list and hence assigned her to one of the two groups. Anesthesiologist (who will be blinded to the collected data until the end of the study) will perform the block techniques and administered the medication.
60 Patients were randomly allocated into two equal groups (each 30 patients):
- Group D-TAP (30 patients): Each patient will receive general anesthesia plus bilateral ultrasound-guided dual TAP [combining TAP and IL/IH nerve blocks]
- Group QL (30 patients): Each patient will receive general anesthesia plus bilateral ultrasound-guided QLB.
Blocks technique:
Both blocks were performed under complete aseptic precautions using ultrasound machine with high-frequency linear probe covered with sterile sheath (Sonoscape® SSI-6000, Chinawith12-6 MHz high-frequency linear probe) and 100-mm needle (B Braun Medical Inc., Bethlehem, PA, USA).
In TAP / Ilioinguinal/Iliohypogastric nerve block, the probe will be located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall will be identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique will be used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine will be injected. Then abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualised between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side.
In QL block, the patient will be positioned supine with lateral tilt to perform the block, and the transducer will be placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border will be visualized (hook sign), leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine will be applied and the same technique will be performed on the other side.
Intraoperative fentanyl 1-2 ug/kg will be given if the HR or the blood pressure or both increase >20% of the baseline. About 30 min before the end of the surgical procedure, paracetamol 1 g IV will be given for all patients. Isoflurane will be discontinued on completion of the surgical procedure, and neostigmine 0.05 mg/kg plus atropine 0.01 mg/kg will be administered to reverse the effect of atracurium. After awakening from anesthesia and achieving an appropriate level of consciousness, the patient will be discharged from the operating room. Visual analog scale (VAS) will be used to assess the postoperative pain; if VAS >3 postoperatively, IV increment of morphine 3 mg will be given. Any side effects were recorded as hypotension (systolic arterial pressure <90 mmHg), arrhythmia, bradycardia (HR <50 beat/min), nausea or vomiting, lower limb muscle weakness, or any other complications.
Measurements:
- Demographic data as age, BMI, ASA status, duration of anesthesia and duration of surgery
- Postoperative pain severity assessed by VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively at 30 min and 2, 4, 6, 12, and 24 h postoperative. Patients with VAS≥ 4 will be received morphine at dose IV increment of morphine 3 mg. while patients with VAS<4 will be received paracetamol 1gm IV infusion.
- The total dose of morphine used postoperatively/patient (rescue analgesia) within first 24 h postoperative.
- The total dose of intraoperatively fentanyl.
- Duration of postoperative analgesia (the time from recovery to the first given dose of morphine)
- Number of patients needed rescue analgesia.
- Any recorded postoperative complication as hypotension (systolic arterial pressure <90 mmHg), arrhythmia, bradycardia (HR <50 beat/min), nausea or vomiting, lower limb muscle weakness, or any other complications
- Conditions
- Hysterectomy
- Being tested
- Quadratus Lumborum Block, Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve blocks
- Keywords
- Hysterectomy, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum BlockProcedure or surgery
transducer will be placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border will be visualized leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine will be applied
Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve blocksProcedure or surgery
the probe will be located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall will be identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique will be used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine will be injected. Then abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualised between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum Block | Experimental | the transducer will be placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border will be visualized, leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial then placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine will be applied Receives: Procedure: Quadratus Lumborum Block |
| Dual block | Experimental | the probe will be located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall will be identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique will be used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine will be injected. Then abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualised between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side. Receives: Procedure: Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of morphine used
The total dose of morphine used postoperatively/patient (rescue analgesia) within first 24 h postoperative
Measured: up to 24 hours postoperative
Secondary outcomes (4)
The total dose of intraoperatively fentanyl
The total dose of intraoperatively fentanyl
Measured: during the procedure/surgery
Duration of postoperative analgesia
Duration of postoperative analgesia (the time from recovery to the first given dose of morphine)
Measured: up to 24 hours postoperative
Number of patients needed rescue analgesia
Number of patients needed rescue analgesia
Measured: up to 24 hours postoperative
Postoperative pain severity
Postoperative pain severity assessed by Visual Analogue Scale for pain
Measured: up to 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 posted11 May 2020
- Study start2 May 2020
- Primary completion31 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Arafa Elbadry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382274
- Sponsor's protocol ID
- QL versus TAB/II&IH block
- Status last verified
- Nov 2023
- First submitted
- 4 May 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block Versus Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve Blocks for Postoperative Analgesia Following Total Abdominal Hysterectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04382274
- Acronym / sponsor ID
- QL versus TAB/II&IH block
- Conditions
- Hysterectomy
- Keywords
- Hysterectomy, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 2 May 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 11 May 2020 (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.
Multimodal pain management program is needed to control severe pain after abdominal hysterectomy which is considered as one of the major abdominal surgeries. Opioids (which are the analgesic of choice) have many adverse effects such as sedation, nausea, and vomiting. Hence, different methods are needed to control pain and decrease opioid consumption and its side effects.
Transversus abdominis plane (TAP) block blocks the sensory afferent nerves run between the abdominal muscles and controls postoperative incisional pain.
Blanco was the first who described the quadratus lumborum block (QLB). Somatic pain after upper and lower abdominal surgery can be controlled by QLB. QLB can be performed for all generations (adult, pediatrics, and pregnant).
QLB is considered to be an easy technique to learn as it is easy to get the key sonoanatomic markers for QLB. The novice can learn this block after only a few performance of the procedure. QLB produces effective postoperative analgesia after abdominal surgery, laparoscopic surgery, anterior abdominal wall surgery, and hip and femur surgery. The analgesic effect of QLB covers 24-48 h. While some authors inserted catheter for continuous infusion of the local anesthetic drug to extend the duration of postoperative analgesia, others added dexamethasone to local anesthetic to extend the effect of local anesthetic drugs.
Ultrasound (US)-guided Ilioinguinal and Iliohypogastric nerve and TAP block have been established as analgesic adjuncts for post hernia repair pain management, under general anaesthesia, neuraxial, MAC and infiltration techniques.
US-guided technique of blocking Ilioinguinal and Iliohypogastric nerves have higher success rate compared to conventional technique. TAP block provides analgesia to the parietal peritoneum and skin of the abdomen in infra-umbilical surgeries. Few cadaveric studies showed good analgesic effect in the region between T10 and L1 following a single posterior TAP injection.
Detailed description
All patients will be assessed preoperatively by history taking, physical examination, and laboratory evaluation. On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, pulse oximetry, and capnography will be applied. Baseline parameters such as systolic blood pressure, diastolic blood pressure, mean blood pressure, heart rate (HR), and arterial oxygen saturation will be also recorded.
Intravenous (IV) line will be inserted and IV fluid will be started. For both groups, general anesthesia will be induced with IV injection of fentanyl (1 µg/kg) (Sunny Pharmaceutical, Egypt) and propofol (2mg/kg) (AstraZeneca, UK), and then, atracurium (0.5 mg/kg) (GlaxoSmithKline, UK) will be injected for endotracheal intubation.
Mechanical ventilation will be maintained to keep the end-expiratory CO2 values between 34 and 36 mmHg. Anesthesia will be continued with isoflurane 1%-2% in 100% O2. Incremental dose of atracurium (0.1 mg/kg) will be given every 30 min or when needed.
After endotracheal intubation and before the start of the surgery. A computer system will be used for randomization by creating a list of number each number referred to one of the two groups. Block randomization will be used to ensure equality of the groups. Each number will be sealed in an opaque envelope. Then, each patient will be asked to choose one of the envelopes and give to an anesthesiologist who compared it to the computer-generated list and hence assigned her to one of the two groups. Anesthesiologist (who will be blinded to the collected data until the end of the study) will perform the block techniques and administered the medication.
60 Patients were randomly allocated into two equal groups (each 30 patients):
- Group D-TAP (30 patients): Each patient will receive general anesthesia plus bilateral ultrasound-guided dual TAP [combining TAP and IL/IH nerve blocks]
- Group QL (30 patients): Each patient will receive general anesthesia plus bilateral ultrasound-guided QLB.
Blocks technique:
Both blocks were performed under complete aseptic precautions using ultrasound machine with high-frequency linear probe covered with sterile sheath (Sonoscape® SSI-6000, Chinawith12-6 MHz high-frequency linear probe) and 100-mm needle (B Braun Medical Inc., Bethlehem, PA, USA).
In TAP / Ilioinguinal/Iliohypogastric nerve block, the probe will be located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall will be identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique will be used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine will be injected. Then abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualised between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side.
In QL block, the patient will be positioned supine with lateral tilt to perform the block, and the transducer will be placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border will be visualized (hook sign), leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine will be applied and the same technique will be performed on the other side.
Intraoperative fentanyl 1-2 ug/kg will be given if the HR or the blood pressure or both increase >20% of the baseline. About 30 min before the end of the surgical procedure, paracetamol 1 g IV will be given for all patients. Isoflurane will be discontinued on completion of the surgical procedure, and neostigmine 0.05 mg/kg plus atropine 0.01 mg/kg will be administered to reverse the effect of atracurium. After awakening from anesthesia and achieving an appropriate level of consciousness, the patient will be discharged from the operating room. Visual analog scale (VAS) will be used to assess the postoperative pain; if VAS >3 postoperatively, IV increment of morphine 3 mg will be given. Any side effects were recorded as hypotension (systolic arterial pressure <90 mmHg), arrhythmia, bradycardia (HR <50 beat/min), nausea or vomiting, lower limb muscle weakness, or any other complications.
Measurements:
- Demographic data as age, BMI, ASA status, duration of anesthesia and duration of surgery
- Postoperative pain severity assessed by VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively at 30 min and 2, 4, 6, 12, and 24 h postoperative. Patients with VAS≥ 4 will be received morphine at dose IV increment of morphine 3 mg. while patients with VAS<4 will be received paracetamol 1gm IV infusion.
- The total dose of morphine used postoperatively/patient (rescue analgesia) within first 24 h postoperative.
- The total dose of intraoperatively fentanyl.
- Duration of postoperative analgesia (the time from recovery to the first given dose of morphine)
- Number of patients needed rescue analgesia.
- Any recorded postoperative complication as hypotension (systolic arterial pressure <90 mmHg), arrhythmia, bradycardia (HR <50 beat/min), nausea or vomiting, lower limb muscle weakness, or any other complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum Block | Experimental | Procedure: Quadratus Lumborum Blockthe transducer will be placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border will be visualized, leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial then placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine will be applied |
| Dual block | Experimental | Procedure: Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve blocksthe probe will be located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall will be identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique will be used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine will be injected. Then abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualised between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1.60 female patients 2. aged 45-60 years 3. ASA Physical Status Class I and II 4. scheduled for abdominal hysterectomy
Key exclusion criteria (6 listed)
- Patients had infection at injection site
- Allergy to local anesthetics
- Coagulation disorders
- Severe obesity
- Physical or mental diseases which could interfere with the evaluation of pain scores
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 |
|---|---|---|
| Quadratus Lumborum Blocktransducer will be placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border will be visualized leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine will be applied | Procedure or surgery | Quadratus Lumborum Block |
| Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve blocksthe probe will be located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall will be identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique will be used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine will be injected. Then abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualised between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side. | Procedure or surgery | Dual block |
Primary outcome
The total dose of morphine used
Time frame: up to 24 hours postoperative
The total dose of morphine used postoperatively/patient (rescue analgesia) within first 24 h postoperative
4 secondary outcomes
The total dose of intraoperatively fentanyl
Time frame: during the procedure/surgery
Duration of postoperative analgesia
Time frame: up to 24 hours postoperative
Number of patients needed rescue analgesia
Time frame: up to 24 hours postoperative
Postoperative pain severity
Time frame: up to 24 hours postoperative
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 30 Nov 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 Quadratus Lumborum Block and Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve blocks in people with Hysterectomy, run by Tanta 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 1 inclusion and 6 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 30 Nov 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?
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?
The total dose of morphine used (time frame: up to 24 hours postoperative). 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 30 Nov 2023.