Pain Management of Inguinal HerniorrhaphyNCT04026243
Ultrasound-Guided Transversalis Fascia Plane Block Versus Transmuscular Quadratus Lumborum Block for Post-operative Analgesia in Inguinal Hernia Repair
A study testing QL block and TF block in people with Pain Management of Inguinal Herniorrhaphy, run by Cairo University at 1 site in Egypt.
Trial summary
Regional blocks as a part of multimodal analgesia can improve pain control in the postoperative period. The transversalis fascia plane (TFP) block can block the proximal portions of the T12 and L1 nerves, while the main advantage of the Quadratus Lumborum (QL) block is the possible extension of the local anesthetic… Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management of Inguinal Herniorrhaphy
- What is being tested?
- QL block and TF block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 31 Aug 2019
- 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All consecutive patients of ASA classification grade I and II,
- aged above 18 years old and less than 65 years old,
- of both sexes,
- body mass index (BMI) below 35,
- who had a capacity to rate pain on a numeric rating scale (NRS) of 0 to --underwent non-recurrent unilateral inguinal hernia repair
Who cannot join
- patient refusal
- patient aged < 18 or > 65 years old,
- ASA classification > II, BMI < 35
- those with previous difficulty in evaluating their level of pain
- any contraindications for local anesthesia as: patient refusal of local anesthesia injection, coagulopathy( defined as either thrombocytopenia (platelet count below 100,000 platelets per microliter and/or prothrombin time greater than 14 seconds ), therapeutic anticoagulation, presence of skin infection or hematoma in the vicinity of the puncture site or those with known allergy to any of the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Regional blocks as a part of multimodal analgesia can improve pain control in the postoperative period. The transversalis fascia plane (TFP) block can block the proximal portions of the T12 and L1 nerves, while the main advantage of the Quadratus Lumborum (QL) block is the possible extension of the local anesthetic beyond the transversus abdominis plane (TAP) plane spreading into the thoracic paravertebral space and anesthetizing both the lateral and anterior cutaneous branches from T7 to L1. the aim of this study is to compare effectiveness of ultrasound-guided transversalis fascia plane block to trans-muscular quadratus lumborum block in providing postoperative analgesia in patients undergoing unilateral inguinal hernia repair.
Read the detailed description
This prospective randomized controlled study will include 50 patients (25 in each group) of American Society of Anesthesiologist (ASA) I and II physical status who will undergo unilateral inguinal herniorrhaphy under general anesthesia. The investigators hypothesize that ultrasound-guided trans-muscular quadratus lumborum block will be more effective than ultrasound guided transversalis fascia plane block in providing postoperative analgesia in these type of patients. Randomization will be done by a computer-generated random numbers. Patients will be blinded to the study groups. All patients will undergo a thorough pre anesthetic check-up and will be premedicated with metoclopramide 10 mg intravenously.
In the operation theatre, an 18-gauge intravenous (IV) catheter will be placed and monitoring devices will be attached which will include electrocardiograph (ECG) using (GE-Datex Ohmeda 5 lead ECG cable), pulse oximetry (SpO2) using (GE- Datex Ohmeda adult finger spO2 sensor), non-invasive blood pressure (NIBP) using (GE-Datex Ohmeda NIBP cuff, adult double tube with bag). Emergency drugs and equipment will be ready and prepared. Numeric pain rating scale will be explained clearly to all patients before conduction of anesthesia.
Anesthesia will be induced with fentanyl (2 mcg/kg) and propofol (1.5-2.5 mg/kg) and atracurium besylate (0.5 mg/Kg). An endotracheal tube will be inserted, and controlled ventilation will be adjusted to maintain normocapnia. Anesthesia will be maintained with sevoflurane at 1% and boluses of atracurium (0.1 mg/Kg) every 30 min. All patients will be given 1 g intravenous paracetamol, together with 4 mg ondansetron 10 min prior to the end of surgery for postoperative nausea and vomiting prophylaxis.
The patients will be classified into two equal groups; Group QL (n=25) and group TF (n=25).
All blocks will be performed on patients, following general anesthesia induction and endotracheal tube insertion, under guidance of a digital ultrasonic diagnostic imaging system (Mindray®, china), using a low frequency (2-6 MHz) curvilinear probe and a 100-150-mm short-bevel echogenic needle. Before ultrasound scanning, the operator will wear sterilized gown and gloves following routine scrubbing, flank skin will be prepared by antiseptic solution and fenestrated drape and dressings will be used for all procedures. After surgical disinfection of ipsilateral flank and protection of the ultrasound probe with a sterile ultrasound probe cover, sterile gel will be applied prior to scanning.
After skin closure, inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered IV after return of patient's spontaneous breathing. Patient will then be transferred to post anesthesia care unit (PACU) for complete recovery and monitoring.
In the PACU; rescue analgesia in the form of intravenous nalbuphine (in 5 mg increments) will be given for a numerical pain score more than 4 in the immediate postoperative period.
The block will be considered a failed block if the patient required more than one 5mg dose of nalbuphine in the first hour postoperatively.
In the ward; rescue analgesia will be given in the form of intravenous nalbuphine (in 5 mg increments) and repeated if needed every half an hour with a maximal dose of 60 mg in 24 hours.
- Being tested
- QL block, TF block
- Keywords
- ultrasound guided regional blocks, Transversalis Fascia Plane Block, Quadratus Lumborum Block, inguinal herniorrhaphy, Pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL blockProcedure or surgery
U/S guided Transmuscular Quadratus Lumborum Block
TF blockProcedure or surgery
Also called TFP block
U/S guided Transversalis Fascia Plane Block
| Study group | Role | What they receive |
|---|---|---|
| QL group (n = 25) | Active comparator | After general anesthesia (GA), patient will be placed in lateral position with side to be anesthetised upwards. U/S probe will be placed in the transverse plane at the abdominal flank immediately cranial to the iliac crest. Then moved dorsally until the QL muscle is identified with its attachment to lateral edge of the transverse process of the L4 vertebral body with identification of shamrock sign. The needle is inserted in-plane to transducer (lateral edge) and tip of needle is advanced through the QL muscle. Once the tip of the needle correctly placed and confirmed by negative aspiration, 2 ml of normal saline will be instilled to confirm correct separation of the plane. Following this, 30 ml of 0.25% bupivacaine will be injected between the QL and psoas major. Receives: Procedure: QL block |
| TF group (n = 25) | Active comparator | After GA, patient will be placed in lateral position with side to be anesthetised upwards. U/S probe will be placed in midaxillary line just cephalad to the iliac crest. Scanning anteriorly will identify the three muscles of the anterior abdominal wall. The transversus abdominis typically tapers to form a hyper echoic aponeurosis that passes posterior to quadratus lumborum. Scan will be continued posteriorly to visualize solid organs or viscera deep to the transversus abdominis. The needle will be positioned such that it enters the skin anterior to the ultrasound probe and passes in-plane posterolateral through the three lateral abdominal muscles. Once the tip of the needle correctly placed and confirmed by negative aspiration, 2 ml of normal saline will be instilled to confirm correct separation of the plane. Following this, 30 ml of 0.25% bupivacaine will be injected between the transversus abdominis muscle and the transversalis fascia anterolateral to quadratus lumborum. Receives: Procedure: TF block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative numeric pain rating scale (NRS) from 0 to 10
Patient-assessed resting and movement-induced pain on a numeric pain rating scale of 0 to 10 (higher score will be taken).
Measured: Measured at 30 minutes postoperatively.
Secondary outcomes (8)
postoperative numeric pain rating scale (NRS) from 0 to 10
Patient-assessed resting and movement-induced pain on a numeric pain rating scale of 0 to 10 (higher score will be taken).
Measured: Measurements at 10 minutes, 30 minutes, 60 minutes and 90 minutes after surgery, and at 24 hours postoperatively
number of increments of rescue analgesia
number of increments of nalbuphine needed in the immediate postoperative period up to 24 hours postoperative
Measured: from 30 mintes up to 24 hours postoperative
level of sensory block in the immediate postoperative period
determined by application of a cold, wet cotton swab: anesthesiologist will compare reaction to the stimulus between the nerve territories on the surgery side to the contralateral territory. Sensitivity will be graded on a scale of 0 to 2 (2: normal sensitivity to cold; 1: hypoesthesia; and 0: anesthesia)
Measured: 10 minutes after PACU admission
Easiness of performance of the block
operator will be asked and his answer will be rated on a simple verbal scale (easy/moderately difficult/difficult) and defined as follows:Easy block: if successful block after the 1st skin puncture and no need for needle image optimization (no adjustment of depth, gain, or focus to visualize the needle path). Moderately difficult block: if successful block after more than one skin puncture attempt or with the need for needle image optimization (as adjustment of depth, gain, or focus to visualize the needle path).Difficult block: if successful block after > one skin puncture attempt and with the need for needle image optimization (as adjustment of depth, gain, or focus to visualize the needle path). N.B: successful block means adequate hydrodissection under U/S
Measured: once during block performance
Block performance time in minutes
Block performance time in minutes (defined as time from probe contact with skin till needle withdrawal
Measured: from U/S probe contact with skin till needle withdrawal up to 30 minuteas afteintubation
Patient satisfaction regarding pain management
a verbal questionnaire (how did you find your pain sensation in the past 6 hours?), patient will describe his/her satisfaction regarding pain management as being (very satisfied, satisfied, not very satisfied, dissatisfied),
Measured: rated 6 hours after surgery
incidence of adverse effects,
incidence of adverse effects, such as postoperative nausea and vomiting, urinary retention, and local anesthetic toxicity
Measured: postoperative up to 24 hours
Failure rate of the block
the block will be considered a failed block if when the patient required more than two 5 mg doses of nalbuphine in the first hour postoperatively
Measured: in the first hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Jan 2019
- Primary completion1 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Management of Inguinal HerniorrhaphyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mohammed El-Hadi Shoukat Mohammed, Cairo University
- Investigators
- Hany MES Mohammed, MD, Principal investigator, www.kasralainy.cu.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026243
- Sponsor's protocol ID
- N-48-2018
- Status last verified
- Jan 2020
- First submitted
- 15 Jul 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Transversalis Fascia Plane Block Versus Transmuscular Quadratus Lumborum Block for Post-operative Analgesia in Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT04026243
- Acronym / sponsor ID
- N-48-2018
- Keywords
- ultrasound guided regional blocks, Transversalis Fascia Plane Block, Quadratus Lumborum Block, inguinal herniorrhaphy, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 19 Jul 2019 (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.
Regional blocks as a part of multimodal analgesia can improve pain control in the postoperative period. The transversalis fascia plane (TFP) block can block the proximal portions of the T12 and L1 nerves, while the main advantage of the Quadratus Lumborum (QL) block is the possible extension of the local anesthetic beyond the transversus abdominis plane (TAP) plane spreading into the thoracic paravertebral space and anesthetizing both the lateral and anterior cutaneous branches from T7 to L1. the aim of this study is to compare effectiveness of ultrasound-guided transversalis fascia plane block to trans-muscular quadratus lumborum block in providing postoperative analgesia in patients undergoing unilateral inguinal hernia repair.
Detailed description
This prospective randomized controlled study will include 50 patients (25 in each group) of American Society of Anesthesiologist (ASA) I and II physical status who will undergo unilateral inguinal herniorrhaphy under general anesthesia. The investigators hypothesize that ultrasound-guided trans-muscular quadratus lumborum block will be more effective than ultrasound guided transversalis fascia plane block in providing postoperative analgesia in these type of patients. Randomization will be done by a computer-generated random numbers. Patients will be blinded to the study groups. All patients will undergo a thorough pre anesthetic check-up and will be premedicated with metoclopramide 10 mg intravenously.
In the operation theatre, an 18-gauge intravenous (IV) catheter will be placed and monitoring devices will be attached which will include electrocardiograph (ECG) using (GE-Datex Ohmeda 5 lead ECG cable), pulse oximetry (SpO2) using (GE- Datex Ohmeda adult finger spO2 sensor), non-invasive blood pressure (NIBP) using (GE-Datex Ohmeda NIBP cuff, adult double tube with bag). Emergency drugs and equipment will be ready and prepared. Numeric pain rating scale will be explained clearly to all patients before conduction of anesthesia.
Anesthesia will be induced with fentanyl (2 mcg/kg) and propofol (1.5-2.5 mg/kg) and atracurium besylate (0.5 mg/Kg). An endotracheal tube will be inserted, and controlled ventilation will be adjusted to maintain normocapnia. Anesthesia will be maintained with sevoflurane at 1% and boluses of atracurium (0.1 mg/Kg) every 30 min. All patients will be given 1 g intravenous paracetamol, together with 4 mg ondansetron 10 min prior to the end of surgery for postoperative nausea and vomiting prophylaxis.
The patients will be classified into two equal groups; Group QL (n=25) and group TF (n=25).
All blocks will be performed on patients, following general anesthesia induction and endotracheal tube insertion, under guidance of a digital ultrasonic diagnostic imaging system (Mindray®, china), using a low frequency (2-6 MHz) curvilinear probe and a 100-150-mm short-bevel echogenic needle. Before ultrasound scanning, the operator will wear sterilized gown and gloves following routine scrubbing, flank skin will be prepared by antiseptic solution and fenestrated drape and dressings will be used for all procedures. After surgical disinfection of ipsilateral flank and protection of the ultrasound probe with a sterile ultrasound probe cover, sterile gel will be applied prior to scanning.
After skin closure, inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered IV after return of patient's spontaneous breathing. Patient will then be transferred to post anesthesia care unit (PACU) for complete recovery and monitoring.
In the PACU; rescue analgesia in the form of intravenous nalbuphine (in 5 mg increments) will be given for a numerical pain score more than 4 in the immediate postoperative period.
The block will be considered a failed block if the patient required more than one 5mg dose of nalbuphine in the first hour postoperatively.
In the ward; rescue analgesia will be given in the form of intravenous nalbuphine (in 5 mg increments) and repeated if needed every half an hour with a maximal dose of 60 mg in 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL group (n = 25) | Active comparator | Procedure: QL blockAfter general anesthesia (GA), patient will be placed in lateral position with side to be anesthetised upwards. U/S probe will be placed in the transverse plane at the abdominal flank immediately cranial to the iliac crest. Then moved dorsally until the QL muscle is identified with its attachment to lateral edge of the transverse process of the L4 vertebral body with identification of shamrock sign. The needle is inserted in-plane to transducer (lateral edge) and tip of needle is advanced through the QL muscle. Once the tip of the needle correctly placed and confirmed by negative aspiration, 2 ml of normal saline will be instilled to confirm correct separation of the plane. Following this, 30 ml of 0.25% bupivacaine will be injected between the QL and psoas major. |
| TF group (n = 25) | Active comparator | Procedure: TF blockAfter GA, patient will be placed in lateral position with side to be anesthetised upwards. U/S probe will be placed in midaxillary line just cephalad to the iliac crest. Scanning anteriorly will identify the three muscles of the anterior abdominal wall. The transversus abdominis typically tapers to form a hyper echoic aponeurosis that passes posterior to quadratus lumborum. Scan will be continued posteriorly to visualize solid organs or viscera deep to the transversus abdominis. The needle will be positioned such that it enters the skin anterior to the ultrasound probe and passes in-plane posterolateral through the three lateral abdominal muscles. Once the tip of the needle correctly placed and confirmed by negative aspiration, 2 ml of normal saline will be instilled to confirm correct separation of the plane. Following this, 30 ml of 0.25% bupivacaine will be injected between the transversus abdominis muscle and the transversalis fascia anterolateral to quadratus lumborum. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All consecutive patients of ASA classification grade I and II,
- aged above 18 years old and less than 65 years old,
- of both sexes,
- body mass index (BMI) below 35,
- who had a capacity to rate pain on a numeric rating scale (NRS) of 0 to --underwent non-recurrent unilateral inguinal hernia repair
Key exclusion criteria (5 listed)
- patient refusal
- patient aged < 18 or > 65 years old,
- ASA classification > II, BMI < 35
- those with previous difficulty in evaluating their level of pain
- any contraindications for local anesthesia as: patient refusal of local anesthesia injection, coagulopathy( defined as either thrombocytopenia (platelet count below 100,000 platelets per microliter and/or prothrombin time greater than 14 seconds ), therapeutic anticoagulation, presence of skin infection or hematoma in the vicinity of the puncture site or those with known allergy to any of the study drugs
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 |
|---|---|---|
| QL blockU/S guided Transmuscular Quadratus Lumborum Block | Procedure or surgery | QL group (n = 25) |
| TF blockAlso: TFP blockU/S guided Transversalis Fascia Plane Block | Procedure or surgery | TF group (n = 25) |
Primary outcome
postoperative numeric pain rating scale (NRS) from 0 to 10
Time frame: Measured at 30 minutes postoperatively.
Patient-assessed resting and movement-induced pain on a numeric pain rating scale of 0 to 10 (higher score will be taken).
8 secondary outcomes
postoperative numeric pain rating scale (NRS) from 0 to 10
Time frame: Measurements at 10 minutes, 30 minutes, 60 minutes and 90 minutes after surgery, and at 24 hours postoperatively
number of increments of rescue analgesia
Time frame: from 30 mintes up to 24 hours postoperative
level of sensory block in the immediate postoperative period
Time frame: 10 minutes after PACU admission
Easiness of performance of the block
Time frame: once during block performance
Block performance time in minutes
Time frame: from U/S probe contact with skin till needle withdrawal up to 30 minuteas afteintubation
Patient satisfaction regarding pain management
Time frame: rated 6 hours after surgery
incidence of adverse effects,
Time frame: postoperative up to 24 hours
Failure rate of the block
Time frame: in the first hour postoperatively
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 14 Jan 2020.
- Individual participant dataSharing planned: Yes
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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.
Hany MES Mohammed, MD principal investigator
www.kasralainy.cu.edu.eg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QL block and TF block in people with Pain Management of Inguinal Herniorrhaphy, run by Cairo 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 5 inclusion and 5 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 14 Jan 2020. 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?
postoperative numeric pain rating scale (NRS) from 0 to 10 (time frame: Measured at 30 minutes postoperatively.). 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 14 Jan 2020.