Comparison of Two Pain-treatment Techniques After Cesarean Section

Phase 4

Completed

• Conditions: Cesarean Section; Neuropathic Pain; Pain Management
• Interventions: Procedure: TAP (transversus abdominis plane block); Procedure: QL (quadratus lumborum block); Drug: Bupivacaine; Device: Needle; Drug: Paracetamol; Drug: Metamizol; Drug: Ketoprofen; Drug: Morphine

• Registration Number: NCT02804126
• Lead Sponsor: Michał Borys

Brief 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.

Study Timeline

• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Study Start: 2017-06-01
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 232

Inclusion Criteria

• obtained consent
• singleton pregnancy
• subarachnoid anaesthesia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP (transversus abdominis plane)	TAP (transversus abdominis plane block)	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
QL (quadratus lumborum)	QL (quadratus lumborum block)	Ultrasound-guided quadratus lumborum block at the end of cesarean section
TAP (transversus abdominis plane)	Needle	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
QL (quadratus lumborum)	Needle	Ultrasound-guided quadratus lumborum block at the end of cesarean section
TAP (transversus abdominis plane)	Bupivacaine	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
TAP (transversus abdominis plane)	Ketoprofen	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
TAP (transversus abdominis plane)	Paracetamol	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
TAP (transversus abdominis plane)	Metamizol	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
QL (quadratus lumborum)	Metamizol	Ultrasound-guided quadratus lumborum block at the end of cesarean section
TAP (transversus abdominis plane)	Morphine	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
QL (quadratus lumborum)	Bupivacaine	Ultrasound-guided quadratus lumborum block at the end of cesarean section
QL (quadratus lumborum)	Paracetamol	Ultrasound-guided quadratus lumborum block at the end of cesarean section
QL (quadratus lumborum)	Ketoprofen	Ultrasound-guided quadratus lumborum block at the end of cesarean section
QL (quadratus lumborum)	Morphine	Ultrasound-guided quadratus lumborum block at the end of cesarean section

Primary Outcome Measures

Name	Time	Method
Postoperative pain measured with VAS	up to 24 hours after surgery	Acute pain measured with VAS (visual-analogue scale).

Secondary Outcome Measures

Name	Time	Method
Neuropathic pain assessed with NPSI	6 months from the surgery	Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)

Trial Locations

Locations (1)

II Department of Anesthesia and Intensive Care; 🇵🇱 Lublin, Poland