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
NCT number | NCT05348083 |
Other study ID # | 4412 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 15, 2021 |
Est. completion date | October 30, 2022 |
Verified date | October 2023 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Gemelli | Roma | RM |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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 |
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