Quadratus Lumborum Block for Post-Cesarean Analgesia

Postoperative Pain Clinical Trial

Official title:

Comparison of Intrathecal Morphine With Quadratus Lumborum Block for Post-Cesarean Delivery Analgesia:

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02339766
• Other study ID #: 106224
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: February 5, 2017

Study information

• Verified date: September 2021
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Most women having planned cesarean section receive spinal anesthetic for the procedure.

Typically, spinal opioids are administered during the same time as a component of multimodal analgesia to provide pain relief in the 16-24 hr period postoperatively. However, spinal opioids are frequently associated with adverse effects such as nausea, pruritus, sedation and occasionally respiratory depression.

The quadratus lumborum (QL) block is a regional analgesic technique which blocks T5-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries and is a potential alternative to spinal opioids. There is some evidence that it may provide visceral along with somatic pain relief. It is a simple and safe technique that has been studied in lower abdominal surgeries, but has not been studied for pain relief after cesarean section.

If found effective, it will have the advantage of a reduction in opioid associated adverse effects while providing similar quality of analgesia. This block has evolved from the previously known transversus abdominis plane block.

We propose to undertake a study that will compare the relative efficacy of QL block with local anesthetic to spinal morphine. We will also study if it provides any incremental benefit when administered in addition to spinal morphine.

Description:

This will be a randomized controlled double blinded trial.

Seventy five female patients belonging to American Society of Anesthesiologists status 1-3, age 18-45 yrs undergoing elective caesarean delivery will be included in this prospective study.

After obtaining informed consent, they will be randomized to one of the three groups by a computer-generated randomization. All patients will receive standard spinal anesthetic. They will be randomized to one of the three groups (n=25 per group).

Groups 1 and 3 will receive intrathecal morphine in addition to the spinal anesthestic. Group 2 will receive equal volume of saline added to the intrathecal mixture.

Ultrasound guided Quadratus Lumborum block will be done. Following negative aspiration, 25 mL of Ropivacaine 0.5% (Groups 2 and 3), or the same amount of saline (Group 1) will be injected in each side.

All patients will receive routine postoperative analgesia, including analgesics and oral morphine.

All patients will be assessed postoperatively by a blinded investigator at 6, 12 and 24h post-operatively.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 5, 2017
• Est. primary completion date: February 5, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Elective cesarean delivery

• American Society of Anesthesiologists Physical Status 1-3

• Suitable for procedure to be carried out under spinal anesthesia

Exclusion Criteria:

• Inability to give informed consent or to co-operate with post-operative evaluation

• Allergy to local anesthetics, morphine, fentanyl, ropivacaine

• Ongoing major medical or psychiatric problems

• Chronic opioid use

• Major coagulopathy

• BMI>35 on first ante natal visit

• Pre-eclampsia

• Contraindication to neuraxial anesthesia

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Quadratus Lumborum Block
Quadratus Lumborum Block with Ropivacaine 0.5% will be done.
• Sham Block
Sham block of Quadratus Lumborum will be done with Saline.

Drug:
• Intrathecal Morphine
Intrathecal Morphine 150 mcg will be co-administered with the spinal anesthetic.
• Intrathecal Saline
Intrathecal Saline 0.15 mL will be co-administered with the spinal anesthetic.

Locations

Country	Name	City	State
Canada	Victoria Hospital- LHSC	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on movement at 12 hrs after surgery	Numeric Rating Scale to evaluate pain scores at 12 h after surgery.	12 hours
Secondary	Pain and Morphine consumption at 6,12 24 hrs after surgery.	Numeric Rating Scale to evaluate pain scores.	24 hours
Secondary	Nausea at 6, 12, 24 hrs after surgery	Nausea will be evaluated according to intensity. 0= no nausea; 1= nausea not requiring pharmacologic treatment; 2= nausea requiring pharmacologic treatment.	24 hours
Secondary	Chronic Wound Pain at 6 weeks	Development of chronic pain around incisional wound will be evaluated by phone interview.	6 weeks
Secondary	Pruritus at 6, 12, 24 hrs after surgery	Pruritus will be evaluated according to intensity 0= no pruritus; 1= pruritus not requiring pharmacologic treatment; 2= pruritus requiring pharmacologic treatment.	24 hours