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Completed

NCT Number: NCT05348083

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

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.

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Key information

Conditions

Pain, Post Operative Anesthesia, Local Cesarean Section Complications Neurologic Manifestations Obstetric Anesthesia Problems Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Gemelli

Roma, RM, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Opioid consumption at 24 h

    Time frame: 24 hours from block performance

    Total morphine consumption at 24 hours from block performance

Secondary outcomes

  1. Intensity of pain at time of block performance

    Time frame: Time of block performance, at the end of surgery

    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)

  2. Intensity of pain at 2 hours

    Time frame: 2 hours from block performance

    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)

  3. Intensity of pain at 6 hours

    Time frame: 6 hours from block performance

    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)

  4. Intensity of pain at 12 hours

    Time frame: 12 hours from block performance

    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)

  5. Intensity of pain at 24 hours

    Time frame: 24 hours from block performance

    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)

  6. Adverse events

    Time frame: Any time during the first 24 hours from block performance.

    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.

  7. Time to first opioid request

    Time frame: Any time during the first 24 hours from block performance

    Interval time between block and first opioid analgesic request

  8. Differences in hemodynamic parameters

    Time frame: Any time during the first 24 hours from block performance

    Any difference in hemodynamic parameters (non-invasive blood pressure, heart rate)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2022
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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