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

NCT ID: NCT03199170

Last Updated: 2019-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Caesarean Section Spinal Anesthesia Quadratus Lumborum Block Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intrathecal morphine

Intrathecal morphine 0.2 mg, 0.9%NSS each side

Group Type SHAM_COMPARATOR

Intrathecal morphine

Intervention Type DRUG

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

Intrathecal morphine with bilateral Quadratus Lumborum Block

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

Group Type EXPERIMENTAL

Intrathecal morphine with bilateral Quadratus Lumborum Block

Intervention Type 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

Bilateral Quadratus Lumborum Block

No intrathecal morphine, 0.25%Bupivacaine 25 ml each side

Group Type EXPERIMENTAL

Bilateral Quadratus Lumborum Block

Intervention Type DRUG

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

Interventions

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Intrathecal morphine

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

Intervention Type DRUG

Bilateral Quadratus Lumborum Block

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pawinee Pangthipampai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Siriraj hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 18818022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27635953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10598635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26638592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24249997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21851346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26174113 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26225500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27755488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26402020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27891579 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33761894 (View on PubMed)

Other Identifiers

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817/2559(EC1)

Identifier Type: -

Identifier Source: org_study_id

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