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

NCT05348083 | Completed

• 1 other identifier: 4412
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Post Operative; Cesarean Section Complications; Anesthesia, Local; Obstetric Anesthesia Problems

Outcome Measures

Primary Outcomes (1)

• Opioid consumption at 24 h

  Total morphine consumption at 24 hours from block performance

  24 hours from block performance

Secondary Outcomes (8)

• Intensity of pain at time of block performance

  Time of block performance, at the end of surgery

• Intensity of pain at 2 hours

  2 hours from block performance

• Intensity of pain at 6 hours

  6 hours from block performance

• Intensity of pain at 12 hours

  12 hours from block performance

• Intensity of pain at 24 hours

  24 hours from block performance

Study Arms (2)

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

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.

Interventions

ESPB PROCEDURE

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.

ESPB

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli

Roma, RM, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Anesthesiologist

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: April 27, 2022
• Study Start: December 15, 2021
• Primary Completion: October 20, 2022
• Study Completion: October 30, 2022
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)