Comparison of Two Pain-treatment Techniques After Cesarean Section

NCT02804126 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2023-11-28

No results posted yet for this study

Summary

Comparison of two types of analgesia after cesarean section.

All patients will anaesthetised with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). 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 Management
  • Neuropathic Pain

Interventions

PROCEDURE

TAP (transversus abdominis plane block)

ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).

PROCEDURE

QL (quadratus lumborum block)

ultrasound-guided regional block between abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).

DRUG

Bupivacaine

In both groups (TAP\&QL) 0.25% bupivacaine will be given (0.2 mL/kg)

DEVICE

Needle

Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study

DRUG

Paracetamol

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

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

Morphine

Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)

Sponsors & Collaborators

  • Michał Borys

    lead OTHER

Principal Investigators

  • Miroslaw Czuczwar, MD, PhD · II Department of Anesthesiology and Intensive Care Medial University of Lublin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Poland

Study Locations

More Related Trials

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 NCT02804126 on ClinicalTrials.gov