TAP vs QLB in Patients After Cesarean Delivery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404908
• Other study ID #: KE-0254/238/2017
• Status: Completed
• Phase: Phase 4
• Start date: February 7, 2018
• Est. completion date: April 17, 2019

Study information

• Verified date: November 2023
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 17, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• obtained consent
• singleton pregnancy
• subarachnoid anesthesia

Exclusion Criteria:

• coagulopathy
• allergy to local anesthetics
• depression, antidepressant drugs treatment
• epilepsy
• usage of painkiller before surgery
• addiction to alcohol or recreational drugs

Related Conditions & MeSH terms

• Cesarean Section
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• TAP (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).
• QL (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).

Drug:
• Ropivacaine
In both groups (TAP&QLB) 0.375% ropivacaine 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
• metamizole
Intravenous metamizole will be used (1.0 gram), up to 4 grams per day
• Ketoprofen
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
• Morphine
Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)

Locations

Country	Name	City	State
Poland	II Department of Anesthesia and Intensive Care, Medical University of Lublin	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Acute pain measured with VAS (visual-analogue scale). VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.	up to 24 hours after the surgery
Secondary	Neuropathic pain	Neuropathic pain occurrence assessed with Neuropathic Pain Symptom Inventory (NPSI) 10 descriptive variables, each one from 0 to 10. 0 means no pain. 10 very high chance of occurrence of neuropathic pain.	6 months from the surgery