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

Completed

• Conditions: Pain, Post Operative; Obstetric Anesthesia Problems; Anesthesia, Local; Cesarean Section Complications
• Interventions: Procedure: ESPB

• Registration Number: NCT05348083
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Primary Completion: 2022-10-20
• Study Completion: 2022-10-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-14
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ESPB	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.

Primary Outcome Measures

Name	Time	Method
Opioid consumption at 24 h	24 hours from block performance	Total morphine consumption at 24 hours from block performance

Secondary Outcome Measures

Name	Time	Method
Intensity of pain at time of block performance	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)
Intensity of pain at 6 hours	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)
Time to first opioid request	Any time during the first 24 hours from block performance	Interval time between block and first opioid analgesic request
Differences in hemodynamic parameters	Any time during the first 24 hours from block performance	Any difference in hemodynamic parameters (non-invasive blood pressure, heart rate)
Intensity of pain at 2 hours	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)
Intensity of pain at 12 hours	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)
Intensity of pain at 24 hours	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)
Adverse events	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.

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli; 🇮🇹 Roma, RM, Italy