Pain PostoperativeNCT02586454
Analgesic Efficacy of Transmuscular Quadratus Lumborum in Patients Undergoing Total Abdominal Hysterectomy
A study testing Transmuscular quadratus lumborum block, morphine and ropivacaine in people with Pain Postoperative, run by Kuala Lumpur General Hospital at 1 site in Malaysia.
Trial summary
Patients who have undergone laparotomies often require multimodal postoperative pain regimes. In recent years, abdominal wall blocks have been included to become part of this in order to overcome side effects of systemic opioids and complications from epidural analgesia. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Pain Postoperative
- What is being tested?
- Transmuscular quadratus lumborum block, morphine and ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteMalaysia
- Study dates
- Nov 2015to Jan 2017
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or II
- Patient's weight > 50kg
- Elective TAH
Who cannot join
- Body mass index (BMI) > 35 kg/m2
- Any contraindications to peripheral nerve blocks i.e. local skin infection, coagulopathy, allergy to LA
- Inability to use patient controlled analgesia
- Patient on antiplatelet, anticoagulant or on regular use of opioids, paracetamol, nonsteroidal anti-inflammatory drugs or tramadol for chronic condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transmuscular Quadratus Lumborum Block for Postoperative Pain After Total Abdominal Hysterectomy
Patients who have undergone laparotomies often require multimodal postoperative pain regimes. In recent years, abdominal wall blocks have been included to become part of this in order to overcome side effects of systemic opioids and complications from epidural analgesia.
Borglum popularised a new approach on abdominal wall blocks by introducing the transmuscular quadratus lumborum (QL) block. Transmuscular QL block is thought to be effective against somatic and visceral pain as local anaesthetic tends to spread from the site of injection to thoracic paravertebral spaces where the sympathetic chain lies.
The objective of this study is to evaluate the analgesic efficacy of transmuscular QL block in patients undergoing total abdominal hysterectomy (TAH) by measuring cumulative opioid consumption, pain score at rest and on movement 24 hours after TAH. Our hypothesis is patients given transmuscular QL block will have lower cumulative opioid consumption.
- Conditions
- Pain Postoperative
- Being tested
- Transmuscular quadratus lumborum block, morphine, ropivacaine
- Keywords
- Transmuscular quadratus lumborum block, total abdominal hysterectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transmuscular quadratus lumborum blockProcedure or surgery
morphineDrug
ropivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Transmuscular quadratus lumborum (QL) block | Experimental | Bilateral QL block using 20 ml 0.375% ropivacaine in each side (to a maximum dose 3 mg/kg) plus patient controlled analgesia morphine (1mg/bolus morphine, lockout time 5 minutes) post operative Receives: Procedure: Transmuscular quadratus lumborum block; Drug: morphine; Drug: ropivacaine |
| Control | Active comparator | Patient controlled analgesia morphine (1mg/bolus morphine, lockout time 5 minutes) post operative Receives: Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative morphine consumption
in mg for 24 hours
Measured: 24 hours after total abdominal hysterectomy
Pain score at rest and movement
using visual analogue scale 1 to 10
Measured: 24 hours after total abdominal hysterectomy
Secondary outcomes (1)
Complications related to the transmuscular QL block
Complications related to transmuscular QL block: Haematoma at site of injection,infection at site of injection Complications related to PCAM:Nausea, vomiting, pruritus, sedation
Measured: 24 hours after total abdominal hysterectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuala Lumpur General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amiruddin Nik Mohamed Kamil, Kuala Lumpur General Hospital
- Investigators
- Amiruddin Nik Mohamed Kamil, MBBS MMed (Anaesthesiology), Principal investigator, Kuala Lumpur General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586454
- Sponsor's protocol ID
- NMRR-15-919-25992
- Status last verified
- Jun 2017
- First submitted
- 23 Oct 2015
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
PubMed 18020088Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.
PubMed 23811424Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.
PubMed 21851346Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
PubMed 24249997Kadam VR. Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. No abstract available.
PubMed 25788791Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9.
PubMed 23927552
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmuscular Quadratus Lumborum Block for Postoperative Pain After Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT02586454
- Acronym / sponsor ID
- NMRR-15-919-25992
- Conditions
- Pain Postoperative
- Keywords
- Transmuscular quadratus lumborum block, total abdominal hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kuala Lumpur General HospitalOther government
- Study start
- Nov 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Oct 2015 (estimated)
- 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.
Patients who have undergone laparotomies often require multimodal postoperative pain regimes. In recent years, abdominal wall blocks have been included to become part of this in order to overcome side effects of systemic opioids and complications from epidural analgesia.
Borglum popularised a new approach on abdominal wall blocks by introducing the transmuscular quadratus lumborum (QL) block. Transmuscular QL block is thought to be effective against somatic and visceral pain as local anaesthetic tends to spread from the site of injection to thoracic paravertebral spaces where the sympathetic chain lies.
The objective of this study is to evaluate the analgesic efficacy of transmuscular QL block in patients undergoing total abdominal hysterectomy (TAH) by measuring cumulative opioid consumption, pain score at rest and on movement 24 hours after TAH. Our hypothesis is patients given transmuscular QL block will have lower cumulative opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transmuscular quadratus lumborum (QL) block | Experimental | Procedure: Transmuscular quadratus lumborum block, Drug: morphine, Drug: ropivacaineBilateral QL block using 20 ml 0.375% ropivacaine in each side (to a maximum dose 3 mg/kg) plus patient controlled analgesia morphine (1mg/bolus morphine, lockout time 5 minutes) post operative |
| Control | Active comparator | Drug: morphinePatient controlled analgesia morphine (1mg/bolus morphine, lockout time 5 minutes) post operative |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I or II
- Patient's weight > 50kg
- Elective TAH
Key exclusion criteria (4 listed)
- Body mass index (BMI) > 35 kg/m2
- Any contraindications to peripheral nerve blocks i.e. local skin infection, coagulopathy, allergy to LA
- Inability to use patient controlled analgesia
- Patient on antiplatelet, anticoagulant or on regular use of opioids, paracetamol, nonsteroidal anti-inflammatory drugs or tramadol for chronic condition
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 |
|---|---|---|
| Transmuscular quadratus lumborum block | Procedure or surgery | Transmuscular quadratus lumborum (QL) block |
| morphine | Drug | Control, Transmuscular quadratus lumborum (QL) block |
| ropivacaine | Drug | Transmuscular quadratus lumborum (QL) block |
Primary outcome
Cumulative morphine consumption
Time frame: 24 hours after total abdominal hysterectomy
in mg for 24 hours
Pain score at rest and movement
Time frame: 24 hours after total abdominal hysterectomy
using visual analogue scale 1 to 10
1 secondary outcome
Complications related to the transmuscular QL block
Time frame: 24 hours after total abdominal hysterectomy
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 20 Jun 2017.
- Background: PubMed 18020088Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
- Background: PubMed 23811424Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.
- Background: PubMed 21851346Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.
- Background: PubMed 24249997Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
- Background: PubMed 25788791Kadam VR. Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. No abstract available.
- Background: PubMed 23927552Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9.
- Related InfoLink provided by the sponsor.
- 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.
Amiruddin Nik Mohamed Kamil, MBBS MMed (Anaesthesiology) principal investigator
Kuala Lumpur General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transmuscular quadratus lumborum block, morphine and ropivacaine in people with Pain Postoperative, run by Kuala Lumpur General Hospital at 1 site in Malaysia.
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 3 inclusion and 4 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 20 Jun 2017. 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 Malaysia. 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 morphine consumption (time frame: 24 hours after total abdominal hysterectomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02586454, which also lists 6 linked publications.
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 20 Jun 2017.