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

Not Applicable
Completed
Conditions
Laparoscopic Cholecystectomy
Interventions
Other: Control group (C)
Other: Transversus abdominis plane Group (TAP)
Other: Quadratus lumborum block Group (QL)
Registration Number
NCT03323684
Lead Sponsor
Mansoura University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
159
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Transversus abdominis plane Group (TAP)Paracetamol infusionSubcostal transversus abdominis plane will be performed
Transversus abdominis plane Group (TAP)Ketorolac analgesiaSubcostal transversus abdominis plane will be performed
Control group (C)Control group (C)Postoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac
Control group (C)Ketorolac analgesiaPostoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac
Transversus abdominis plane Group (TAP)Transversus abdominis plane Group (TAP)Subcostal transversus abdominis plane will be performed
Quadratus lumborum block Group (QL)Quadratus lumborum block Group (QL)Quadratus lumborum block will be performed
Quadratus lumborum block Group (QL)Ketorolac analgesiaQuadratus lumborum block will be performed
Quadratus lumborum block Group (QL)Paracetamol infusionQuadratus lumborum block will be performed
Control group (C)Paracetamol infusionPostoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac
Transversus abdominis plane Group (TAP)fentanylSubcostal transversus abdominis plane will be performed
Quadratus lumborum block Group (QL)fentanylQuadratus lumborum block will be performed
Control group (C)fentanylPostoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac
Primary Outcome Measures
NameTimeMethod
Cumulative postoperative fentanyl consumption (total dose given in micrograms)For 24 hours after surgery
Secondary Outcome Measures
NameTimeMethod
Mean arterial blood pressure (mmHg)For 4 hours after start of anaesthesia

Changes in intra-operative mean arterial blood pressure values

Dermatomal distribution of the extent of the blockade will be assessed by pinprick methodthe first one hour after surgery

Assessment of dermatomal distribution of the block for evaluating the success or failure of the block

Postoperative pain severity will be assessed using VASFor 24 hours after surgery

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

Cumulative intraoperative fentanyl consumption (total dose given in micrograms)For 4 hours after start of anaesthesia

Cumulative use of fentanyl during intra-operative period

Heart rateFor 4 hours after start of anaesthesia

Changes in intra-operative heart rate values

Time for the first request to rescue analgesia (in minutes)For 24 hours after surgery

Time for first request to rescue analgesia

length of stay at PACU (in minutes)For 24 hours after surgery
Incidence of postoperative nausea and vomitingFor 24 hours after surgery

Trial Locations

Locations (2)

Mansoura University, Faculty of Medicine

🇪🇬

Mansourah, DK, Egypt

Mansoura University

🇪🇬

Mansourah, DK, Egypt

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