NCT02804126

Comparison of Two Pain-treatment Techniques After Cesarean Section

Effectiveness of Transversus Abdominis Plane Block Versus Quadratus Lumborum Technique in Patients After Cesarean Section

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Michał Borys · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Written consent will be obtained before the cesarean section. Only subarachnoidally anaesthetised 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 (0.25 % bupivacaine) on each side. Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of operation. Paracetamol, metamizol, 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

• Cesarean Section
• Pain Management
• Neuropathic Pain

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2016-06-17
• Last updated: 2023-11-28

Locations

1 site across 1 country: Poland