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Caesarean SectionNCT03199170

Effect of Bilateral Quadratus Lumborum Block for Pain Relief in Patients With Cesarean Section

A study testing Intrathecal morphine, Bilateral Quadratus Lumborum Block and Intrathecal morphine with bilateral Quadratus Lumborum Block in people with Caesarean Section and Spinal Anesthesia, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cesarean section commonly induces moderate to severe pain for 48 hours. These patients have additional compelling reasons to provide adequate pain relief as early mobilization is a key factor to prevent the risk of thromboembolic event which is increased during pregnancy. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Intrathecal morphine, Bilateral Quadratus Lumborum Block and Intrathecal morphine with bilateral Quadratus Lumborum Block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteThailand
Study dates
1 Sep 2017to 1 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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All singleton pregnant women with gestation of at least 37 weeks scheduled for elective cesarean section with American Society of Anesthesiologists (ASA) physical status 1 or 2

Who cannot join

  • refuse to receive spinal block
  • allergy to drugs used in research: morphine, local anesthetic drug and paracetamol
  • abnormal coagulopathy: congenital coagulopathy or who used anticoagulants
  • platelet dysfunction or thrombocytopenia
  • distorted anatomical structures of lumbar spines
  • systemic infection or local infection at both flank areas which are the punctures sites for quadratus lumborum block
  • unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Siriraj hospital

    Bangkok, 10700

Other trials in Thailand

About this study

Cesarean section commonly induces moderate to severe pain for 48 hours. These patients have additional compelling reasons to provide adequate pain relief as early mobilization is a key factor to prevent the risk of thromboembolic event which is increased during pregnancy. Beside these, patients need to be pain free to takecare for their newborn and breastfeed them. Poorly controlled pain after cesarean section also increases risk of chronic pain and postpartum depression.

Intrathecal morphine is considered the "gold standard" for postoperative pain relief after cesarean delivery. The duration of analgesic effect of morphine extend to 12-24 hours. Its widespread use is due to its favorable pharmacokinetic profile, ease of administration and low cost. Although intrathecal morphine is highly effective, its use is associated with undesirable adverse effect particularly nausea, vomiting and pruritus which reduce overall patients' satisfaction. More serious complication is the risk of delayed maternal respiratory depression.

Read more

The Quadratus Lumborum block was first described in 2007 which demonstrates a spread to the paravertebral space, thus leads to a more extensive block to T5-L1 nerve branches and a long lasting block with the potential to provide visceral pain relief. Therefore, this block has an evolving role in postoperative analgesia for many lower abdominal surgeries. As the safety is concerned, there has been one report of a patient with unilateral hip flexion and knee extension weakness leading to unplanned overnight admission following lateral quadratus lumborum block after laparoscopic gynaecological operation.

If the result favors effective, it will have the advantage of a combination with intrathecal opioid to prolong the pain free period after cesarean section which has about 4,000 cases per year.

Being tested
Intrathecal morphine, Bilateral Quadratus Lumborum Block, Intrathecal morphine with bilateral Quadratus Lumborum Block
Keywords
Caesarean Section, Spinal anesthesia, Quadratus lumborum block, Postoperative pain, Intrathecal morphine
Medical subject headings
Agnosia, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intrathecal morphineDrug

    0.5% Hyperbaric bupivacaine 2 ml add morphine 0.2 mg for spinal anesthesia

  • Bilateral Quadratus Lumborum BlockDrug

    0.25% Bupivacaine 25 ml each side for quadratus lumborum block without spinal morphine

  • Intrathecal morphine with bilateral Quadratus Lumborum BlockDrug

    0.5% Hyperbaric bupivacaine 2 ml add morphine 0.2 mg for spinal anesthesia and 0.25% Bupivacaine 25 ml each side for quadratus lumborum block

Study groups in NCT03199170
Study groupRoleWhat they receive
Intrathecal morphineSham comparatorIntrathecal morphine 0.2 mg, 0.9%NSS each side
Receives: Drug: Intrathecal morphine
Intrathecal morphine with bilateral Quadratus Lumborum BlockExperimentalIntrathecal morphine 0.2 mg, 0.25%Bupivacaine 25 ml each side
Receives: Drug: Intrathecal morphine with bilateral Quadratus Lumborum Block
Bilateral Quadratus Lumborum BlockExperimentalNo intrathecal morphine, 0.25%Bupivacaine 25 ml each side
Receives: Drug: Bilateral Quadratus Lumborum Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first analgesic request (PCA morphine)

    Whether bilateral quadratus lumborum block can increase pain free period of patients undergo cesarean section under spinal block with intrathecal morphine or not

    Measured: 48 hours postoperatively

Secondary outcomes (4)

  1. Pain score

    Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative

    Measured: 48 hours postoperatively

  2. Requirement of rescue pain

    Requirement of pain control medication

    Measured: 48 hours postoperatively

  3. Adverse effect

    Incidence of side effects e.g. nausea and vomiting, itching and sedation

    Measured: 48 hours postoperatively

  4. Satisfaction score

    Satisfaction score rated from 0-100

    Measured: 48 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2017
  2. Study start1 Sep 2017
  3. Primary completion1 Jan 2019
  4. Study completion1 Aug 2019

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03199170
Sponsor's protocol ID
817/2559(EC1)
Status last verified
Sep 2019
First submitted
22 Jun 2017
Last updated
26 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.

    PubMed 18818022

  • Weibel S, Neubert K, Jelting Y, Meissner W, Wockel A, Roewer N, Kranke P. Incidence and severity of chronic pain after caesarean section: A systematic review with meta-analysis. Eur J Anaesthesiol. 2016 Nov;33(11):853-865. doi: 10.1097/EJA.0000000000000535.

    PubMed 27635953

  • Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.

    PubMed 10598635

  • Triyasunant N, Chinachoti T, Duangburong S. Direct Field Block with 40 ML of 0.125% Bupivacaine in Conjunction with Intrathecal Morphine for Analgesia after Cesarean Section: A Randomized Controlled Trial. J Med Assoc Thai. 2015 Oct;98(10):1001-9.

    PubMed 26638592

  • Kadam 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 24249997

  • Carney 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 21851346

  • Baidya DK, Maitra S, Arora MK, Agarwal A. Quadratus lumborum block: an effective method of perioperative analgesia in children undergoing pyeloplasty. J Clin Anesth. 2015 Dec;27(8):694-6. doi: 10.1016/j.jclinane.2015.05.006. Epub 2015 Jul 11. No abstract available.

    PubMed 26174113

  • Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.

    PubMed 26225500

  • Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.

    PubMed 27755488

  • Shaaban M, Esa WA, Maheshwari K, Elsharkawy H, Soliman LM. Bilateral Continuous Quadratus Lumborum Block for Acute Postoperative Abdominal Pain as a Rescue After Opioid-Induced Respiratory Depression. A A Case Rep. 2015 Oct 1;5(7):107-11. doi: 10.1213/XAA.0000000000000188.

    PubMed 26402020

  • Wikner M. Unexpected motor weakness following quadratus lumborum block for gynaecological laparoscopy. Anaesthesia. 2017 Feb;72(2):230-232. doi: 10.1111/anae.13754. Epub 2016 Nov 28.

    PubMed 27891579

  • Pangthipampai P, Dejarkom S, Poolsuppasit S, Luansritisakul C, Tangchittam S. Bilateral posterior Quadratus Lumborum block for pain relief after cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2021 Mar 25;21(1):90. doi: 10.1186/s12871-021-01309-6.

    PubMed 33761894

Questions about this trial

What is this clinical trial studying?

A study testing Intrathecal morphine, Bilateral Quadratus Lumborum Block and Intrathecal morphine with bilateral Quadratus Lumborum Block in people with Caesarean Section and Spinal Anesthesia, run by Mahidol University at 1 site in Thailand.

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 7 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 26 Sep 2019. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?

Time to first analgesic request (PCA morphine) (time frame: 48 hours postoperatively). 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 NCT03199170, which also lists 12 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 26 Sep 2019.

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