Regional Analgesia After Cesarean Section

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244540
• Other study ID #: KE-0254/127/2017
• Status: Completed
• Phase: Phase 4
• Start date: September 4, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: February 2020
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 30, 2019
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Neuralgia
• Pain, Neuropathic
• Pain, Postoperative

Intervention

Procedure:
• TAP (transversus abdominis plane block)
ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
• 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)
• 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
• 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
• Ketoprofen
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
• Bupivacaine
Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)

Locations

Country	Name	City	State
Poland	Szpital Specjalistyczny PRO-FAMILIA w Rzeszowie	Rzeszów
Poland	Szpital Kliniczny Dzieciatka Jezus	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

References & Publications (2)

Kadam VR. Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. — View Citation

Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain measured with VAS	Acute pain measured with VAS (visual-analogue scale)	up to 24 hours after surgery
Secondary	Neuropathic pain assessed with NPSI	Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)	6 months from the surgery
Secondary	Morphine consumption	Total morphine consumption	up to 24 hours after surgery