Erector Spinae Plane Block (ESPB) Versus Quadratus Lumborum Block (QLB) for Postoperative Analgesia After Caesarean Section

Bilateral Erector Spinae Plane Block (ESPB) Versus Posterior Quadratus Lumborum Block (p-QLB) for Postoperative Analgesia After Caesarean Section: an Observational Closed Mixed Cohort Study

Management of pain after caesarean section represents an important anesthesiologic issue, since it is often suboptimal, leading to delayed functional recovery and chronic pain. Currently, the postoperative analgesic strategy mostly relies on intrathecal morphine (ITM) and multimodal analgesic regimen. Recently, the need for alterative opioid sparing techniques is emerging. Paraspinal fascial plane blocks, as quadratus lumborum block (QLB) and erector spinae plane block (ESPB) performed at T9 level, have therefore been proposed as alternatives to ITM, because of their demonstrated effect on visceral and somatic pain.

The aim of the study is to assess the efficacy, the feasibility and safety of bilateral ESPB compared to bilateral QLB for the management of postoperative pain after ceasarean section conducted under spinal anesthesia without ITM.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Cesarean Section Complications; Pain, Post Operative; Obstetric Anesthesia Problems
• Intervention / Treatment: Procedure: ESPB

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy
      • Fondazione Policlinico Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study is an observational comparative study, including a prospective cohort (the ESPB group) and a historical control group (the p-QLB group) from our institution.

Description

Inclusion Criteria:

- Patients ASA 2 with normal singleton pregnancy, scheduled for elective caesarean section without intrathecal morphine, who underwent bilateral ESPB at the end of surgery an who gave informed consent to data collection.

Exclusion Criteria:

• Contraindications to spinal anesthesia;
• Contraindications to or a history of opioid dependence;
• Allergy to local anesthetics, acetaminophen, NSAIDs
• Inability to understand pain assessment scales or to use Patient Controlled Analgesia (PCA) pump;
• Patient refusal.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ESPB; A prospective cohort of 25 patients ASA 2 (according to American Society of Anesthesiologists physical status classification) with normal singleton pregnancy, scheduled for elective caesarean section under spinal anesthesia without intrathecal morphine, who underwent bilateral echo-guided ESPB at T9 level at the end of surgery.	Procedure: ESPB; Echo-guided bilateral ESPB performed at T9 level at the end of surgery with a mixture of ropivacaine 0.375% and epinephrine 5 mcg/mL 20 mL each side.
p-QLB; A historical cohort of 25 patients ASA 2 (according to American Society of Anesthesiologists physical status classification) with normal singleton pregnancy, scheduled for elective caesarean section under spinal anesthesia without intrathecal morphine, who underwent bilateral echo-guided p-QLB at the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption at 24 h	Total morphine consumption at 24 hours from block performance	24 hours from block performance

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of pain at time of block performance	NRS (Numeric Rating Scale) for pain at rest and on movement at time of block performance. NRS is an 11-point numeric scale ranging from 0 (= no pain) to 10 (=extreme pain)	Time of block performance, at the end of surgery
Intensity of pain at 2 hours	NRS (Numeric Rating Scale) for pain at rest and on movement at 2 hours from block performance. NRS is an 11-point numeric scale ranging from 0 (= no pain) to 10 (=extreme pain)	2 hours from block performance
Intensity of pain at 6 hours	NRS (Numeric Rating Scale) for pain at rest and on movement at 6 hours from block performance. NRS is an 11-point numeric scale ranging from 0 (= no pain) to 10 (=extreme pain)	6 hours from block performance
Intensity of pain at 12 hours	NRS (Numeric Rating Scale) for pain at rest and on movement at 12 hours from block performance. NRS is an 11-point numeric scale ranging from 0 (= no pain) to 10 (=extreme pain)	12 hours from block performance
Intensity of pain at 24 hours	NRS (Numeric Rating Scale) for pain at rest and on movement at 24 hours from block performance. NRS is an 11-point numeric scale ranging from 0 (= no pain) to 10 (=extreme pain)	24 hours from block performance
Adverse events	Any adverse events, like sedation, itching, nausea, and other complications, particularly signs of local anesthetic toxicity, the occurrence or persistence of motor weakness at the lower extremities after spinal anesthesia recovery.	Any time during the first 24 hours from block performance.
Time to first opioid request	Interval time between block and first opioid analgesic request	Any time during the first 24 hours from block performance
Differences in hemodynamic parameters	Any difference in hemodynamic parameters (non-invasive blood pressure, heart rate)	Any time during the first 24 hours from block performance

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): October 20, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 14, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 4412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No