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

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT03199170

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Sep 1, 2017

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time to first analgesic request (PCA morphine) [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

Pain score [48 hours postoperatively]
Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative
Requirement of rescue pain [48 hours postoperatively]
Requirement of pain control medication
Adverse effect [48 hours postoperatively]
Incidence of side effects e.g. nausea and vomiting, itching and sedation
Satisfaction score [48 hours postoperatively]
Satisfaction score rated from 0-100

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

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