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

NCT03199170 | Completed DMC

• 1 other identifier: 817/2559(EC1)
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Caesarean Section; Spinal Anesthesia; Quadratus Lumborum Block; Analgesia

Keywords

Caesarean Section; Spinal anesthesia; Quadratus lumborum block; Postoperative pain; Intrathecal morphine

Outcome Measures

Primary Outcomes (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

  48 hours postoperatively

Secondary Outcomes (4)

• Pain score

  48 hours postoperatively

• Requirement of rescue pain

  48 hours postoperatively

• Adverse effect

  48 hours postoperatively

• Satisfaction score

  48 hours postoperatively

Study Arms (3)

Intrathecal morphine

SHAM COMPARATOR

Intrathecal morphine 0.2 mg, 0.9%NSS each side

Drug: Intrathecal morphine

Intrathecal morphine with bilateral Quadratus Lumborum Block

EXPERIMENTAL

Intrathecal morphine 0.2 mg, 0.25%Bupivacaine 25 ml each side

Drug: Intrathecal morphine with bilateral Quadratus Lumborum Block

Bilateral Quadratus Lumborum Block

EXPERIMENTAL

No intrathecal morphine, 0.25%Bupivacaine 25 ml each side

Drug: Bilateral Quadratus Lumborum Block

Interventions

Intrathecal morphine DRUG

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

Intrathecal morphine

Bilateral Quadratus Lumborum Block DRUG

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

Bilateral Quadratus Lumborum Block

Intrathecal morphine with bilateral Quadratus Lumborum Block DRUG

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

Intrathecal morphine with bilateral Quadratus Lumborum Block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj hospital

Bangkok, 10700, Thailand

Location

Related Publications (12)

• 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.

  PMID: 18818022 BACKGROUND

• 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.

  PMID: 27635953 BACKGROUND

• 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.

  PMID: 10598635 BACKGROUND

• 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.

  PMID: 26638592 BACKGROUND

• 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.

  PMID: 24249997 BACKGROUND

• 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.

  PMID: 21851346 BACKGROUND

• 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.

  PMID: 26174113 BACKGROUND

• 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.

  PMID: 26225500 BACKGROUND

• 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.

  PMID: 27755488 BACKGROUND

• 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.

  PMID: 26402020 BACKGROUND

• 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.

  PMID: 27891579 BACKGROUND

• 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.

  PMID: 33761894 DERIVED

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Pawinee Pangthipampai, M.D.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 26, 2017
• Study Start: September 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

TH (1)