Clinical trial NCT05348083: Erector Spinae Plane Block (ESPB) Versus Quadratus Lumborum Block (QLB) for Postoperative Analgesia After Caesarean Section
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Post Operative
Cesarean Section Complications
Anesthesia, Local
Obstetric Anesthesia Problems
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Opioid consumption at 24 h
timeFrame: 24 hours from block performance
Secondary outcomes:
measure: Intensity of pain at time of block performance
timeFrame: Time of block performance, at the end of surgery
measure: Intensity of pain at 2 hours
timeFrame: 2 hours from block performance
measure: Intensity of pain at 6 hours
timeFrame: 6 hours from block performance
measure: Intensity of pain at 12 hours
timeFrame: 12 hours from block performance
measure: Intensity of pain at 24 hours
timeFrame: 24 hours from block performance
measure: Adverse events
timeFrame: Any time during the first 24 hours from block performance.
measure: Time to first opioid request
timeFrame: Any time during the first 24 hours from block performance
measure: Differences in hemodynamic parameters
timeFrame: Any time during the first 24 hours from block performance
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli
state: RM
Study officials:
References: