Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-cholecystectomy Analgesia

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Analgesic Efficacy of Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03323684
• Other study ID #: MD/17.09.09
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: March 15, 2018

Study information

• Verified date: April 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In laparoscopic cholecystectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain) due to trocar insertion sites, visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after laparoscopic cholecystectomy may predict development of chronic pain (e.g., postlaparoscopic cholecystectomy syndrome). Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

Recently, the uses of peripheral axial blocks that deliver local anesthetic into the transversus abdominis fascial plane have become popular for operations that involve incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been shown to reduce perioperative opioid use in elective abdominal surgery, including open appendicectomy, laparotomy, and laparoscopic cholecystectomy. However, the efficacy of the TAP block is reportedly only reliable in providing analgesia below the umbilicus. The ultrasound-guided subcostal transversus abdominis (STA) block is a recently described variation on the TAP block which produces reliable supraumbilical analgesia. Deposition of local anesthetic in this plane has shown to block dermatomes T6 to T10 with an occasional spread to T12. This variant will be discussed in our study.

Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic cholecystectomy has not been investigated before and it is the variant that will be discussed in our study.

Description:

The aim of this study is to compare the analgesic efficacy of ultrasound guided posterior quadratus lumborum block and subcostal transversus abdominis plane block in laparoscopic cholecystectomy. The primary outcome will be assessment of postoperative opioid analgesic requirements. The secondary outcomes will include assessing intraoperative analgesic requirements, stress of trocar insertion and insufflation, postoperative visual analogue scale (VAS), length of stay at post-anesthesia care unit (PACU), time of first request to analgesia, incidence of nausea, and vomiting.

The study will hypothesize that quadratus lumborum block will be more superior than or equal to transversus abdominis block because it could cover all the dermatome segments from caudally L1 to cranially till T6 segments as the drug is expected to travel from the QL to the higher paravertebral spaces.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: March 15, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• American Physical Status I or II

Exclusion Criteria:

• Patient refusal.

• Hematological diseases

• bleeding disorders.

• Coagulation abnormality.

• Psychiatric diseases.

• Local skin infection

• sepsis at site of the block.

• Known intolerance to the study drugs.

• Body Mass Index > 40 Kg/m2.

• Emergency laparoscopic cholecystectomy

• if laparoscopic procedure converted to open.

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Other:
• Quadratus lumborum block Group (QL)
20 mL of 0.375% isobaric bupivacaine for each side deposited at the posterior aspect of the quadratus lumborum muscle (QLB type 2) using ultrasound after induction of general anesthesia and 15 minutes before start of surgery
• Transversus abdominis plane Group (TAP)
20 mL of 0.375% isobaric bupivacaine for each side using ultrasound after induction of general anesthesia and 15 minutes before start of surgery
• Control group (C)
No intervention will be done

Drug:
• Paracetamol infusion
Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.
• Ketorolac analgesia
In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.
• fentanyl
With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, Fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Postoperatively, Fentanyl boluses (20 micrograms) will be given if VAS is more than 3 and it might be repeated after 30 minutes until VAS is = 3.

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansourah	DK
Egypt	Mansoura University, Faculty of Medicine	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative postoperative fentanyl consumption (total dose given in micrograms)		For 24 hours after surgery
Secondary	Cumulative intraoperative fentanyl consumption (total dose given in micrograms)	Cumulative use of fentanyl during intra-operative period	For 4 hours after start of anaesthesia
Secondary	Heart rate	Changes in intra-operative heart rate values	For 4 hours after start of anaesthesia
Secondary	Mean arterial blood pressure (mmHg)	Changes in intra-operative mean arterial blood pressure values	For 4 hours after start of anaesthesia
Secondary	Dermatomal distribution of the extent of the blockade will be assessed by pinprick method	Assessment of dermatomal distribution of the block for evaluating the success or failure of the block	the first one hour after surgery
Secondary	Postoperative pain severity will be assessed using VAS	The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain	For 24 hours after surgery
Secondary	Time for the first request to rescue analgesia (in minutes)	Time for first request to rescue analgesia	For 24 hours after surgery
Secondary	length of stay at PACU (in minutes)		For 24 hours after surgery
Secondary	Incidence of postoperative nausea and vomiting		For 24 hours after surgery