Quadratus Lumborum Block for Post-Cesarean Analgesia

Lawson Health Research Institute

Status: Terminated

Conditions: Postoperative Pain

Treatments: Procedure: Sham Block; Procedure: Quadratus Lumborum Block; Drug: Intrathecal Saline; Drug: Intrathecal Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02339766

106224

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8 participants in 3 patient groups

Group 1

Sham Comparator group

Description:

Group 1 will receive intrathecal morphine co-administered with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Sham Block be done with 25 mL of saline per side.

Treatment:

Drug: Intrathecal Morphine

Procedure: Sham Block

Group 2

Active Comparator group

Description:

Group 2 will receive an equivalent volume of intrathecal saline co-administered with the spinal anesthetic. After surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side.

Treatment:

Procedure: Quadratus Lumborum Block

Drug: Intrathecal Saline

Group 3

Active Comparator group

Description:

Group 3 will receive will receive intrathecal morphine with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side.

Treatment:

Drug: Intrathecal Morphine

Procedure: Quadratus Lumborum Block