TAP vs QLB in Patients After Cesarean Delivery

Phase 4

Completed

• Conditions: Cesarean Section; Postoperative Pain
• Interventions: Procedure: TAP (transversus abdominis plane block); Procedure: QL (quadratus lumborum block); Drug: Ropivacaine; Device: Needle; Drug: paracetamol; Drug: metamizole; Drug: Ketoprofen; Drug: Morphine

• Registration Number: NCT03404908
• Lead Sponsor: Medical University of Lublin

Brief 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.

Study Timeline

• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-19
• Study Start: 2018-02-07
• Primary Completion: 2019-01-14
• Study Completion: 2019-04-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

• obtained consent
• singleton pregnancy
• subarachnoid anesthesia

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP	Needle	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
QLB	Needle	Ultrasound-guided quadratus lumborum block at the end of cesarean section
TAP	TAP (transversus abdominis plane block)	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
QLB	QL (quadratus lumborum block)	Ultrasound-guided quadratus lumborum block at the end of cesarean section
QLB	Morphine	Ultrasound-guided quadratus lumborum block at the end of cesarean section
TAP	metamizole	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
TAP	Ropivacaine	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
TAP	paracetamol	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
TAP	Morphine	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
TAP	Ketoprofen	Ultrasound-guided transversus abdominis plane block at the end of cesarean section
QLB	Ropivacaine	Ultrasound-guided quadratus lumborum block at the end of cesarean section
QLB	paracetamol	Ultrasound-guided quadratus lumborum block at the end of cesarean section
QLB	Ketoprofen	Ultrasound-guided quadratus lumborum block at the end of cesarean section
QLB	metamizole	Ultrasound-guided quadratus lumborum block at the end of cesarean section

Primary Outcome Measures

Name	Time	Method
Postoperative pain	up to 24 hours after the surgery	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.

Secondary Outcome Measures

Name	Time	Method
Neuropathic pain	6 months from the surgery	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.

Trial Locations

Locations (1)

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