Laparoscopic CholecystectomyNCT03323684
Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-cholecystectomy Analgesia
A study testing Quadratus lumborum block Group (QL), Transversus abdominis plane Group (TAP) and Paracetamol infusion in people with Laparoscopic Cholecystectomy, run by Mansoura University at 2 sites in Egypt.
Trial summary
In laparoscopic cholecystectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain) due to trocar insertion sites, visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Quadratus lumborum block Group (QL), Transversus abdominis plane Group (TAP) and Paracetamol infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Oct 2017to 15 Mar 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Physical Status I or II
Who cannot join
- Patient refusal.
- Hematological diseases
- bleeding disorders.
- Coagulation abnormality.
- Psychiatric diseases.
- Local skin infection
Show all 11Show fewer
- sepsis at site of the block.
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2.
- Emergency laparoscopic cholecystectomy
- if laparoscopic procedure converted to open.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mansoura University, Faculty of Medicine
Al Mansurah, DK, 050
Mansoura University
Al Mansurah, DK, 050
About this study
Official title: Analgesic Efficacy of Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy
In laparoscopic cholecystectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain) due to trocar insertion sites, visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after laparoscopic cholecystectomy may predict development of chronic pain (e.g., postlaparoscopic cholecystectomy syndrome). Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.
Recently, the uses of peripheral axial blocks that deliver local anesthetic into the transversus abdominis fascial plane have become popular for operations that involve incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been shown to reduce perioperative opioid use in elective abdominal surgery, including open appendicectomy, laparotomy, and laparoscopic cholecystectomy. However, the efficacy of the TAP block is reportedly only reliable in providing analgesia below the umbilicus. The ultrasound-guided subcostal transversus abdominis (STA) block is a recently described variation on the TAP block which produces reliable supraumbilical analgesia. Deposition of local anesthetic in this plane has shown to block dermatomes T6 to T10 with an occasional spread to T12. This variant will be discussed in our study.
Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic cholecystectomy has not been investigated before and it is the variant that will be discussed in our study.
Read the detailed description
The aim of this study is to compare the analgesic efficacy of ultrasound guided posterior quadratus lumborum block and subcostal transversus abdominis plane block in laparoscopic cholecystectomy. The primary outcome will be assessment of postoperative opioid analgesic requirements. The secondary outcomes will include assessing intraoperative analgesic requirements, stress of trocar insertion and insufflation, postoperative visual analogue scale (VAS), length of stay at post-anesthesia care unit (PACU), time of first request to analgesia, incidence of nausea, and vomiting.
The study will hypothesize that quadratus lumborum block will be more superior than or equal to transversus abdominis block because it could cover all the dermatome segments from caudally L1 to cranially till T6 segments as the drug is expected to travel from the QL to the higher paravertebral spaces.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Quadratus lumborum block Group (QL), Transversus abdominis plane Group (TAP), Control group (C), Paracetamol infusion, Ketorolac analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum block Group (QL)Other
20 mL of 0.375% isobaric bupivacaine for each side deposited at the posterior aspect of the quadratus lumborum muscle (QLB type 2) using ultrasound after induction of general anesthesia and 15 minutes before start of surgery
Transversus abdominis plane Group (TAP)Other
20 mL of 0.375% isobaric bupivacaine for each side using ultrasound after induction of general anesthesia and 15 minutes before start of surgery
Control group (C)Other
No intervention will be done
Paracetamol infusionDrug
Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.
Ketorolac analgesiaDrug
In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.
fentanylDrug
With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, Fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Postoperatively, Fentanyl boluses (20 micrograms) will be given if VAS is more than 3 and it might be repeated after 30 minutes until VAS is ≤ 3.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block Group (QL) | Experimental | Quadratus lumborum block will be performed Receives: Other: Quadratus lumborum block Group (QL); Drug: Paracetamol infusion; Drug: Ketorolac analgesia; Drug: fentanyl |
| Transversus abdominis plane Group (TAP) | Experimental | Subcostal transversus abdominis plane will be performed Receives: Other: Transversus abdominis plane Group (TAP); Drug: Paracetamol infusion; Drug: Ketorolac analgesia; Drug: fentanyl |
| Control group (C) | Experimental | Postoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac Receives: Other: Control group (C); Drug: Paracetamol infusion; Drug: Ketorolac analgesia; Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative postoperative fentanyl consumption (total dose given in micrograms)
Measured: For 24 hours after surgery
Secondary outcomes (8)
Cumulative intraoperative fentanyl consumption (total dose given in micrograms)
Cumulative use of fentanyl during intra-operative period
Measured: For 4 hours after start of anaesthesia
Heart rate
Changes in intra-operative heart rate values
Measured: For 4 hours after start of anaesthesia
Mean arterial blood pressure (mmHg)
Changes in intra-operative mean arterial blood pressure values
Measured: For 4 hours after start of anaesthesia
Dermatomal distribution of the extent of the blockade will be assessed by pinprick method
Assessment of dermatomal distribution of the block for evaluating the success or failure of the block
Measured: the first one hour after surgery
Postoperative pain severity will be assessed using VAS
The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
Measured: For 24 hours after surgery
Time for the first request to rescue analgesia (in minutes)
Time for first request to rescue analgesia
Measured: For 24 hours after surgery
length of stay at PACU (in minutes)
Measured: For 24 hours after surgery
Incidence of postoperative nausea and vomiting
Measured: For 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Oct 2017
- Primary completion1 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Y Makharita, MD, Study chair, Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323684
- Sponsor's protocol ID
- MD/17.09.09
- Status last verified
- Apr 2018
- First submitted
- 17 Oct 2017
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03323684
- Acronym / sponsor ID
- MD/17.09.09
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 27 Oct 2017 (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.
In laparoscopic cholecystectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain) due to trocar insertion sites, visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after laparoscopic cholecystectomy may predict development of chronic pain (e.g., postlaparoscopic cholecystectomy syndrome). Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.
Recently, the uses of peripheral axial blocks that deliver local anesthetic into the transversus abdominis fascial plane have become popular for operations that involve incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been shown to reduce perioperative opioid use in elective abdominal surgery, including open appendicectomy, laparotomy, and laparoscopic cholecystectomy. However, the efficacy of the TAP block is reportedly only reliable in providing analgesia below the umbilicus. The ultrasound-guided subcostal transversus abdominis (STA) block is a recently described variation on the TAP block which produces reliable supraumbilical analgesia. Deposition of local anesthetic in this plane has shown to block dermatomes T6 to T10 with an occasional spread to T12. This variant will be discussed in our study.
Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic cholecystectomy has not been investigated before and it is the variant that will be discussed in our study.
Detailed description
The aim of this study is to compare the analgesic efficacy of ultrasound guided posterior quadratus lumborum block and subcostal transversus abdominis plane block in laparoscopic cholecystectomy. The primary outcome will be assessment of postoperative opioid analgesic requirements. The secondary outcomes will include assessing intraoperative analgesic requirements, stress of trocar insertion and insufflation, postoperative visual analogue scale (VAS), length of stay at post-anesthesia care unit (PACU), time of first request to analgesia, incidence of nausea, and vomiting.
The study will hypothesize that quadratus lumborum block will be more superior than or equal to transversus abdominis block because it could cover all the dermatome segments from caudally L1 to cranially till T6 segments as the drug is expected to travel from the QL to the higher paravertebral spaces.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum block Group (QL) | Experimental | Other: Quadratus lumborum block Group (QL), Drug: Paracetamol infusion, Drug: Ketorolac analgesia, Drug: fentanylQuadratus lumborum block will be performed |
| Transversus abdominis plane Group (TAP) | Experimental | Other: Transversus abdominis plane Group (TAP), Drug: Paracetamol infusion, Drug: Ketorolac analgesia, Drug: fentanylSubcostal transversus abdominis plane will be performed |
| Control group (C) | Experimental | Other: Control group (C), Drug: Paracetamol infusion, Drug: Ketorolac analgesia, Drug: fentanylPostoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Physical Status I or II
Key exclusion criteria (11 listed)
- Patient refusal.
- Hematological diseases
- bleeding disorders.
- Coagulation abnormality.
- Psychiatric diseases.
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 block Group (QL)20 mL of 0.375% isobaric bupivacaine for each side deposited at the posterior aspect of the quadratus lumborum muscle (QLB type 2) using ultrasound after induction of general anesthesia and 15 minutes before start of surgery | Other | Quadratus lumborum block Group (QL) |
| Transversus abdominis plane Group (TAP)20 mL of 0.375% isobaric bupivacaine for each side using ultrasound after induction of general anesthesia and 15 minutes before start of surgery | Other | Transversus abdominis plane Group (TAP) |
| Control group (C)No intervention will be done | Other | Control group (C) |
| Paracetamol infusionParacetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. | Drug | Control group (C), Quadratus lumborum block Group (QL), Transversus abdominis plane Group (TAP) |
| Ketorolac analgesiaIn PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours. | Drug | Control group (C), Quadratus lumborum block Group (QL), Transversus abdominis plane Group (TAP) |
| fentanylWith induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, Fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Postoperatively, Fentanyl boluses (20 micrograms) will be given if VAS is more than 3 and it might be repeated after 30 minutes until VAS is ≤ 3. | Drug | Control group (C), Quadratus lumborum block Group (QL), Transversus abdominis plane Group (TAP) |
Primary outcome
Cumulative postoperative fentanyl consumption (total dose given in micrograms)
Time frame: For 24 hours after surgery
8 secondary outcomes
Cumulative intraoperative fentanyl consumption (total dose given in micrograms)
Time frame: For 4 hours after start of anaesthesia
Heart rate
Time frame: For 4 hours after start of anaesthesia
Mean arterial blood pressure (mmHg)
Time frame: For 4 hours after start of anaesthesia
Dermatomal distribution of the extent of the blockade will be assessed by pinprick method
Time frame: the first one hour after surgery
Postoperative pain severity will be assessed using VAS
Time frame: For 24 hours after surgery
Time for the first request to rescue analgesia (in minutes)
Time frame: For 24 hours after surgery
length of stay at PACU (in minutes)
Time frame: For 24 hours after surgery
Incidence of postoperative nausea and vomiting
Time frame: For 24 hours after surgery
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 1 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed Y Makharita, MD study chair
Professor of Anesthesia and Surgical Intensive Care
2 sites 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 Group (QL), Transversus abdominis plane Group (TAP) and Paracetamol infusion in people with Laparoscopic Cholecystectomy, run by Mansoura University at 2 sites 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 11 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 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Cumulative postoperative fentanyl consumption (total dose given in micrograms) (time frame: For 24 hours after surgery). 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 1 May 2018.