Regional Analgesia After Cesarean Section

Phase 4

Completed

• Conditions: Pain, Postoperative; Pain, Neuropathic; Cesarean Section
• Interventions: Procedure: TAP (transversus abdominis plane block); Drug: Paracetamol; Procedure: QLB (quadratus lumborum block); Procedure: subarachnoid anesthesia; Device: Stimuplex Ultra 360 needle; Drug: Ropivacaine; Drug: Ketoprofen; Procedure: PCA (patient controlled analgesia); Drug: Metamizol; Drug: Bupivacaine

• Registration Number: NCT03244540
• Lead Sponsor: Medical University of Lublin

Brief 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.

Study Timeline

• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-09
• Study Start: 2017-09-04
• Primary Completion: 2018-10-29
• Study Completion: 2019-08-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-16
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

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

Inclusion Criteria

• obtained consent
• singleton pregnancy
• subarachnoid anaesthesia

Exclusion Criteria

• coagulopathy
• allergy to morphine and 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
PCA	subarachnoid anesthesia	Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
TAP	TAP (transversus abdominis plane block)	Subarchnoid anesthesia with bupivacaine 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 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
PCA	Paracetamol	Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
TAP	Stimuplex Ultra 360 needle	Subarchnoid anesthesia with bupivacaine 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 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
TAP	Ropivacaine	Subarchnoid anesthesia with bupivacaine 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 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
TAP	subarachnoid anesthesia	Subarchnoid anesthesia with bupivacaine 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 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
TAP	PCA (patient controlled analgesia)	Subarchnoid anesthesia with bupivacaine 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 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
PCA	Ketoprofen	Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
PCA	PCA (patient controlled analgesia)	Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
QLB	QLB (quadratus lumborum block)	Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
QLB	Stimuplex Ultra 360 needle	Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
QLB	PCA (patient controlled analgesia)	Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
TAP	Metamizol	Subarchnoid anesthesia with bupivacaine 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 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
TAP	Bupivacaine	Subarchnoid anesthesia with bupivacaine 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 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
QLB	Metamizol	Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
QLB	subarachnoid anesthesia	Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
PCA	Metamizol	Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
PCA	Bupivacaine	Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
TAP	Paracetamol	Subarchnoid anesthesia with bupivacaine 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 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
TAP	Ketoprofen	Subarchnoid anesthesia with bupivacaine 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 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
QLB	Paracetamol	Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
QLB	Ropivacaine	Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
QLB	Ketoprofen	Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
QLB	Bupivacaine	Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU

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)
Morphine consumption	up to 24 hours after surgery	Total morphine consumption

Trial Locations

Locations (2)

Szpital Specjalistyczny PRO-FAMILIA w Rzeszowie; 🇵🇱 Rzeszów, Poland

Szpital Kliniczny Dzieciątka Jezus; 🇵🇱 Warszawa, Poland