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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02586454
Other study ID # NMRR-15-919-25992
Secondary ID
Status Completed
Phase N/A
First received October 23, 2015
Last updated June 18, 2017
Start date November 2015
Est. completion date January 2017

Study information

Verified date June 2017
Source Kuala Lumpur General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients who have undergone laparotomies often require multimodal postoperative pain regimes. In recent years, abdominal wall blocks have been included to become part of this in order to overcome side effects of systemic opioids and complications from epidural analgesia.

Borglum popularised a new approach on abdominal wall blocks by introducing the transmuscular quadratus lumborum (QL) block. Transmuscular QL block is thought to be effective against somatic and visceral pain as local anaesthetic tends to spread from the site of injection to thoracic paravertebral spaces where the sympathetic chain lies.

The objective of this study is to evaluate the analgesic efficacy of transmuscular QL block in patients undergoing total abdominal hysterectomy (TAH) by measuring cumulative opioid consumption, pain score at rest and on movement 24 hours after TAH. Our hypothesis is patients given transmuscular QL block will have lower cumulative opioid consumption.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

1. ASA I or II

2. Patient's weight > 50kg

3. Elective TAH

Exclusion Criteria:

1. Body mass index (BMI) > 35 kg/m2

2. Any contraindications to peripheral nerve blocks i.e. local skin infection, coagulopathy, allergy to LA

3. Inability to use patient controlled analgesia

4. Patient on antiplatelet, anticoagulant or on regular use of opioids, paracetamol, nonsteroidal anti-inflammatory drugs or tramadol for chronic condition

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transmuscular quadratus lumborum block

Drug:
morphine

ropivacaine


Locations

Country Name City State
Malaysia Hospital Kuala Lumpur Kuala Lumpur

Sponsors (1)

Lead Sponsor Collaborator
Kuala Lumpur General Hospital

Country where clinical trial is conducted

Malaysia, 

References & Publications (6)

Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27. Review. — View Citation

Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18. — View Citation

Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. — View Citation

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

Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative morphine consumption in mg for 24 hours 24 hours after total abdominal hysterectomy
Primary Pain score at rest and movement using visual analogue scale 1 to 10 24 hours after total abdominal hysterectomy
Secondary Complications related to the transmuscular QL block Complications related to transmuscular QL block: Haematoma at site of injection,infection at site of injection Complications related to PCAM:Nausea, vomiting, pruritus, sedation 24 hours after total abdominal hysterectomy
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