Quadratus Lumborum Block After Cesarean Section: Analgesic Efficacy of Different Concentrations of Local Anesthetics

NCT05643846 | Active Not Recruiting DMC

• 1 other identifier: RP DAE/2022/102
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

QLB is an injection of a local anesthetics around the quadratus lumborum muscle. It uses a fascial compartment path to extend the distribution of local anesthetics into the posterior abdominal wall and paravertebral space. This central effect can be of vital importance when managing the visceral pain after caesarean section. Many studies have shown that the inclusion of quadratus lumborum block to a multimodal analgesic regimen would reduce pain scores, opioid consumption, and prolonging time to first rescue analgesic after cesarean delivery. However, the dose and concentration of the local anesthetic used among the studies are varied, and literature search identified no randomized controlled trial which looked at the concentration -response of local anesthetic to optimize the concentration resulting in the best pain relief. It is a perspective randomized controlled trial to compare the analgesic efficacy of 2 different concentrations of Bupivacaine to standardize postoperative analgesic protocol used for QLB after caesarean section.

Conditions

Outcome Measures

Outcome Measures

Primary Outcomes (6)

• Morphine dose requirements for pain control after surgery

  Actual doses of PCA morphine, in milligram unit, delivered to the participant after surgery on Day 0, Day1, and on Day2 after surgery.

  Day 0, Day1, Day 2 after surgery.

• Total number of morphine demands after surgery.

  Total number of PCA morphine demands after surgery on Day 0, on Day1, and on Day2 after surgery.

  Day 0, Day1, Day 2 after surgery.

• Assessment of heart rate changes from baseline after surgery.

  Measurement of heart rate in Beat per minutes changes from baseline after surgery. On Day 0 after surgery, on Day1, and on Day2 after surgery.

  Day 0, On Day1, and on Day 2 after surgery.

• Assessment of respiratory rate changes from baseline.

  Measurement of respiratory rate in breath per minutes changes from baseline. On Day 0 after surgery, on Day1, and on Day2 after surgery.

  Day 0, On Day1, and on Day 2 after surgery.

• Assessment of Oxygen saturation changes from baseline.

  Measurement of oxygen saturation percentage changes from baseline. On Day 0 after surgery, on Day1, and on Day2 after surgery.

  Day 0 after surgery, on Day1, and on Day2 after surgery.

• Noninvasive blood pressure changes from baseline after surgery.

  Noninvasive Measurement of blood pressure after surgery in Milliliter of mercury changes from baseline. Measurement of Systolic and diastolic blood pressure changes on Day 0 after surgery, on Day1, and on Day2 after surgery.

  Day 0 after surgery, on Day1, and on Day2 after surgery.

Secondary Outcomes (3)

• Post operative Pain score

  On Day 0, On Day1, and on Day 2.

• Measurement of Time to mobilization in hours after surgery.

  From 1st hour up to 48th hour after surgery.

• Assessment of Nausea and Vomiting postoperative.

  From 1st hour up to 48th hour after surgery.

Study Arms (2)

(Group 1) will receive the intervention 'Bupivacaine at concentration of 0.125%, dose of 0.2 ml/kg'.

ACTIVE COMPARATOR

(Group 1) will receive bilateral QLB procedure with the intervention 'Bupivacaine local anesthetic drug at concentration of 0.125% concentration, at a dose of 0.2 ml/kg'.

Procedure: QLB procedure after cesarean section

(Group 2) will receive the intervention 'Bupivacaine concentration of 0.25%, dose of 0.2 ml/kg'.

ACTIVE COMPARATOR

(Group 2) will receive bilateral QLB procedure with the intervention 'Bupivacaine local anesthetic drug at a concentration of 0.25% concentration, at a dose of 0.2 ml/kg'.

Procedure: QLB procedure after cesarean section

Interventions

QLB procedure after cesarean section PROCEDURE

Bupivacaine local anesthetic drug used for QLB procedure after Cesarean section. Intervention of two different concentration of Bupivacaine, 0.125% or 0.25%, at a dose of 0.2 ml/kg.

Also known as: Bupivacaine Local anesthetic drug at concentrations of 0.125% or 0.25%, Marcaine local anesthetic drug at concentration of 0.125% or 0.25%, at a dose of 0.2ml/kg

(Group 1) will receive the intervention 'Bupivacaine at concentration of 0.125%, dose of 0.2 ml/kg'.; (Group 2) will receive the intervention 'Bupivacaine concentration of 0.25%, dose of 0.2 ml/kg'.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who are American Society of Anesthesiologists physical status 1 or 2.
• Participants who have singleton pregnancy at a gestation of at least 37 weeks.
• Participant who are scheduled for elective caesarean section under spinal anesthesia.
• Participants who are consented to be enrolled into the study.

You may not qualify if:

• Patients who have contraindications to spinal or regional anesthesia (Coagulopathy or on anticoagulants).
• Who have Allergy or sensitivity to study medications.
• Who have anatomical abnormalities or localized infection.
• Who have history of chronic pain or on regular opioids use.
• Who are unable to comprehend or unable to use the verbal rating pain scoring system,
• Failed spinal anesthesia or conversion to general anesthesia after spinal anesthesia.

Sponsors & Collaborators

• Danat Al Emarat Hospital: lead

Study Sites (1)

Danat Al Emarat hospital

Abu Dhabi, United Arab Emirates

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are allocated randomly by means of computer generation sequencing. The allocation sequence with unique study number for each participant will be concealed in sequentially numbered, opaque, sealed, and stapled envelopes. This envelope will be opened by an anesthetist who was not involved in the study. This Anesthetist prepares the study medication as per the allocation and labels the syringe with the unique study number; this number will be used to identify the study medication and will be revealed only on completion of data collection at the end of the study. The investigators, participants and other healthcare providers who are involved in postoperative care, are blinded to the participant's group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: It is a Prospective, Double-blinded, randomized and controlled clinical trial.

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: December 9, 2022
• Study Start: February 27, 2023
• Primary Completion: September 6, 2025
• Study Completion: December 6, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

AE (1)