Regional Analgesia After Cesarean Section

Medical University of Lublin

Status and phase: Completed; Phase 4

Conditions: Cesarean Section; Pain, Postoperative; Pain, Neuropathic

Treatments: Procedure: QLB (quadratus lumborum block); Procedure: TAP (transversus abdominis plane block); Drug: Metamizol; Drug: Paracetamol; Procedure: subarachnoid anesthesia; Drug: Ketoprofen; Drug: Bupivacaine; Device: Stimuplex Ultra 360 needle; Procedure: PCA (patient controlled analgesia); Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03244540

KE-0254/127/2017

Details and patient eligibility

About

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).

Full 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.

Enrollment: 105 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups

PCA

Experimental group

Description:

Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU

Treatment:

Drug: Ketoprofen

Drug: Bupivacaine

Procedure: subarachnoid anesthesia

Procedure: PCA (patient controlled analgesia)

Drug: Metamizol

Drug: Paracetamol

TAP

Experimental group

Description:

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

Treatment:

Procedure: TAP (transversus abdominis plane block)

Drug: Ketoprofen

Device: Stimuplex Ultra 360 needle

Drug: Bupivacaine

Procedure: subarachnoid anesthesia

Procedure: PCA (patient controlled analgesia)

Drug: Metamizol

Drug: Ropivacaine

Drug: Paracetamol

QLB

Experimental group

Description:

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

Treatment:

Drug: Ketoprofen

Device: Stimuplex Ultra 360 needle

Drug: Bupivacaine

Procedure: subarachnoid anesthesia

Procedure: QLB (quadratus lumborum block)

Procedure: PCA (patient controlled analgesia)

Drug: Metamizol

Drug: Ropivacaine

Drug: Paracetamol