Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199170
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.


Condition or disease Intervention/treatment Phase
Caesarean Section Spinal Anesthesia Quadratus Lumborum Block Analgesia Drug: Intrathecal morphine Drug: Bilateral Quadratus Lumborum Block Drug: Intrathecal morphine with bilateral Quadratus Lumborum Block Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Bilateral Quadratus Lumborum Block for Pain Relief in Patients With Cesarean Section
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Sham Comparator: Intrathecal morphine
Intrathecal morphine 0.2 mg, 0.9%NSS each side
Drug: Intrathecal morphine
0.5% Hyperbaric bupivacaine 2 ml add morphine 0.2 mg for spinal anesthesia

Experimental: Intrathecal morphine with bilateral Quadratus Lumborum Block
Intrathecal morphine 0.2 mg, 0.25%Bupivacaine 25 ml each side
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

Experimental: Bilateral Quadratus Lumborum Block
No intrathecal morphine, 0.25%Bupivacaine 25 ml each side
Drug: Bilateral Quadratus Lumborum Block
0.25% Bupivacaine 25 ml each side for quadratus lumborum block without spinal morphine




Primary Outcome Measures :
  1. Time to first analgesic request (PCA morphine) [ Time Frame: 48 hours postoperatively ]
    Whether bilateral quadratus lumborum block can increase pain free period of patients undergo cesarean section under spinal block with intrathecal morphine or not


Secondary Outcome Measures :
  1. Pain score [ Time Frame: 48 hours postoperatively ]
    Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative

  2. Requirement of rescue pain [ Time Frame: 48 hours postoperatively ]
    Requirement of pain control medication

  3. Adverse effect [ Time Frame: 48 hours postoperatively ]
    Incidence of side effects e.g. nausea and vomiting, itching and sedation

  4. Satisfaction score [ Time Frame: 48 hours postoperatively ]
    Satisfaction score rated from 0-100



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199170


Locations
Layout table for location information
Thailand
Siriraj hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Layout table for investigator information
Principal Investigator: Pawinee Pangthipampai, M.D. Siriraj Hospital

Publications:

Layout table for additonal information
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03199170     History of Changes
Other Study ID Numbers: 817/2559(EC1)
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Caesarean Section
Spinal anesthesia
Quadratus lumborum block
Postoperative pain
Intrathecal morphine
Additional relevant MeSH terms:
Layout table for MeSH terms
Morphine
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics