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

Anesthesia, Local Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05348083
• Other study ID #: 4412
• Status: Completed
• Start date: December 15, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: October 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 30, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Cesarean Section Complications
• Obstetric Anesthesia Problems
• Pain, Post Operative
• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption at 24 h	Total morphine consumption at 24 hours from block performance	24 hours from block performance
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	Time to first opioid request	Interval time between block and first opioid analgesic request	Any time during the first 24 hours from block performance
Secondary	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