An interventional study of Quadratus lumborum block Group (QL) and Transversus abdominis plane Group (TAP) in Laparoscopic Cholecystectomy, sponsored by Mansoura University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-05-01.
Sponsored by Mansoura University · Not applicable, Interventional, and Basic science
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.
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.
Mansoura University is the lead sponsor of 1,115 studies on the registry; 184 are open to participants now.
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Exclusion Criteria:
Quadratus lumborum block will be performed
Other: Quadratus lumborum block Group (QL) · Drug: Paracetamol infusion · Drug: Ketorolac analgesia · Drug: fentanyl
Subcostal transversus abdominis plane will be performed
Other: Transversus abdominis plane Group (TAP) · Drug: Paracetamol infusion · Drug: Ketorolac analgesia · Drug: fentanyl
Postoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac
Other: Control group (C) · Drug: Paracetamol infusion · Drug: Ketorolac analgesia · Drug: fentanyl
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
20 mL of 0.375% isobaric bupivacaine for each side using ultrasound after induction of general anesthesia and 15 minutes before start of surgery
No intervention will be done
Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.
In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.
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.
Cumulative postoperative fentanyl consumption (total dose given in micrograms)
Time frame: For 24 hours after surgery
Cumulative intraoperative fentanyl consumption (total dose given in micrograms)
Cumulative use of fentanyl during intra-operative period
Time frame: For 4 hours after start of anaesthesia
Heart rate
Changes in intra-operative heart rate values
Time frame: For 4 hours after start of anaesthesia
Mean arterial blood pressure (mmHg)
Changes in intra-operative mean arterial blood pressure values
Time frame: For 4 hours after start of anaesthesia
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
Time frame: the first one hour after surgery
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
Time frame: For 24 hours after surgery
Time for the first request to rescue analgesia (in minutes)
Time for first request to rescue analgesia
Time frame: For 24 hours after surgery
length of stay at PACU (in minutes)
Time frame: For 24 hours after surgery
Incidence of postoperative nausea and vomiting
Time frame: For 24 hours after surgery
Plan to share: Undecided
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