Regional Analgesia After Cesarean Section

NCT03244540 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-02-18

No results posted yet for this study

Summary

All patients will be anaesthetized with spinal technique. Each patient will be treated with intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Total morphine consumption and time to the first demand will be noted. 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).

Conditions

  • Cesarean Section
  • Pain, Postoperative
  • Pain, Neuropathic

Interventions

PROCEDURE

TAP (transversus abdominis plane block)

ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain

PROCEDURE

QLB (quadratus lumborum block)

ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain

DEVICE

Stimuplex Ultra 360 needle

ultrasound-guided needle will be used for QLB and TAP and regional blocks

DRUG

Ropivacaine

0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)

DRUG

Paracetamol

Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

PROCEDURE

subarachnoid anesthesia

subarachnoid anesthesia for each patients participating in the study with pencil point needle

PROCEDURE

PCA (patient controlled analgesia)

All patients will receive PCA pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit)

DRUG

Metamizol

Intravenous metamizol will be used (1.0 gram), up to 4 grams per day

DRUG

Ketoprofen

Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day

DRUG

Bupivacaine

Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)

Sponsors & Collaborators

  • Medical University of Lublin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-04
Primary Completion
2018-10-29
Completion
2019-08-30

Countries

  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03244540 on ClinicalTrials.gov