Clinical Trials Directory

Trials / Completed

CompletedNCT03404908

TAP vs QLB in Patients After Cesarean Delivery

Postoperative Analgesia With Transversus Abdominis Plane Block or Quadratus Lumborum Block in Patients After Cesarian Delivery

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
105 (actual)
Sponsor
Medical University of Lublin · Academic / Other
Sex
Female
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

Comparison of two types of analgesia after cesarean section All patients will be anesthetized with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will be measured with visual-analog scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).

Detailed description

Written consent will be obtained before the cesarean section. Only subarachnoidally anesthetized patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used. At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.375 % ropivacaine) on each side. Postoperative pain will be measured with VAS (visual-analog scale) 2, 4, 8, 12 and 24 hours after the end of the operation. Paracetamol, metamizole, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day). 1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

Conditions

Interventions

TypeNameDescription
PROCEDURETAP (transversus abdominis plane block)the ultrasound-guided regional block of abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375% ropivacaine administered (0.2 mL/kg).
PROCEDUREQL (quadratus lumborum block)the ultrasound-guided regional block of abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with a distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).
DRUGRopivacaineIn both groups (TAP\&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)
DEVICENeedleUltrasound-guided, Stimuplex ultra 360 needle will be used in the study
DRUGparacetamolIntravenous paracetamol will be used (1.0 gram), up to 4 grams per day
DRUGmetamizoleIntravenous metamizole will be used (1.0 gram), up to 4 grams per day
DRUGKetoprofenIntravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
DRUGMorphineIntravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)

Timeline

Start date
2018-02-07
Primary completion
2019-01-14
Completion
2019-04-17
First posted
2018-01-19
Last updated
2023-11-24

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT03404908. Inclusion in this directory is not an endorsement.