NCT03244540

Regional Analgesia After Cesarean Section

Efficacy of Regional Analgesia Techniques (Quadratus Lumborum Block and Transversus Abdominis Plane Block) in Acute and Chronic Pain Treatment in Patients After Cesarean Delivery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Medical University of Lublin · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

All patients will be anaesthetized with spinal technique. Each patient will be treated with intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Total morphine consumption and time to the first demand will be noted. 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. All patients will receive PCA (patient controlled analgesia) pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit). In PACU vital signs will be monitored. Each patient will be randomly assigned to one of three groups. In the first group of patients no additional regional analgesia will be performed. In the second and the third group, ultrasound-guided transversus abdominis plane or quadratus lumborum block will be done with 0.375 % ropivacaine (0.2 ml per kg 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. 1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

Conditions

• Cesarean Section
• Pain, Postoperative
• Pain, Neuropathic

Interventions

Type	Name	Description
PROCEDURE	TAP (transversus abdominis plane block)	ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
PROCEDURE	QLB (quadratus lumborum block)	ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
DEVICE	Stimuplex Ultra 360 needle	ultrasound-guided needle will be used for QLB and TAP and regional blocks
DRUG	Ropivacaine	0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)
DRUG	Paracetamol	Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
PROCEDURE	subarachnoid anesthesia	subarachnoid anesthesia for each patients participating in the study with pencil point needle
PROCEDURE	PCA (patient controlled analgesia)	All patients will receive PCA pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit)
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	Bupivacaine	Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)

Timeline

• Start date: 2017-09-04
• Primary completion: 2018-10-29
• Completion: 2019-08-30
• First posted: 2017-08-09
• Last updated: 2020-02-18

Locations

2 sites across 1 country: Poland