Clinical trial NCT03323684: Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-cholecystectomy Analgesia
Official title: Analgesic Efficacy of Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative postoperative fentanyl consumption (total dose given in micrograms)
timeFrame: For 24 hours after surgery
Secondary outcomes:
measure: Cumulative intraoperative fentanyl consumption (total dose given in micrograms)
timeFrame: For 4 hours after start of anaesthesia
measure: Heart rate
timeFrame: For 4 hours after start of anaesthesia
measure: Mean arterial blood pressure (mmHg)
timeFrame: For 4 hours after start of anaesthesia
measure: Dermatomal distribution of the extent of the blockade will be assessed by pinprick method
timeFrame: the first one hour after surgery
measure: Postoperative pain severity will be assessed using VAS
timeFrame: For 24 hours after surgery
measure: Time for the first request to rescue analgesia (in minutes)
timeFrame: For 24 hours after surgery
measure: length of stay at PACU (in minutes)
timeFrame: For 24 hours after surgery
measure: Incidence of postoperative nausea and vomiting
timeFrame: For 24 hours after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University, Faculty of Medicine
state: DK
city: Mansourah
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Mohamed Y Makharita, MD
role: STUDY_CHAIR
References: