Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04382274 |
| Other study ID # |
QL versus TAB/II&IH block |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2, 2020 |
| Est. completion date |
November 1, 2020 |
Study information
| Verified date |
November 2023 |
| Source |
Tanta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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:
1. Demographic data as age, BMI, ASA status, duration of anesthesia and duration of surgery
2. 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.
3. 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
