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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199170
• Other study ID #: 817/2559(EC1)
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: September 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

1. refuse to receive spinal block

2. allergy to drugs used in research: morphine, local anesthetic drug and paracetamol

3. abnormal coagulopathy: congenital coagulopathy or who used anticoagulants

4. platelet dysfunction or thrombocytopenia

5. distorted anatomical structures of lumbar spines

6. systemic infection or local infection at both flank areas which are the punctures sites for quadratus lumborum block

7. unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia

Related Conditions & MeSH terms

• Analgesia
• Caesarean Section
• Quadratus Lumborum Block
• Spinal Anesthesia

Intervention

Drug:
• Intrathecal morphine
0.5% Hyperbaric bupivacaine 2 ml add morphine 0.2 mg for spinal anesthesia
• Bilateral Quadratus Lumborum Block
0.25% Bupivacaine 25 ml each side for quadratus lumborum block without spinal morphine
• Intrathecal morphine with bilateral Quadratus Lumborum Block
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

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. Erratum in: Reg Anesth Pain Med. 2018;43:111. — View Citation

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. — View Citation

Dahl JB, Jeppesen IS, Jørgensen H, Wetterslev J, Møiniche 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Weibel S, Neubert K, Jelting Y, Meissner W, Wöckel 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. Review. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours postoperatively
Secondary	Pain score	Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative	48 hours postoperatively
Secondary	Requirement of rescue pain	Requirement of pain control medication	48 hours postoperatively
Secondary	Adverse effect	Incidence of side effects e.g. nausea and vomiting, itching and sedation	48 hours postoperatively
Secondary	Satisfaction score	Satisfaction score rated from 0-100	48 hours postoperatively