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Completed

NCT Number: NCT03323684

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University, Al Mansurah, DK, Egypt

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quadratus lumborum block Group (QL)

Other

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)

Other

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)

Other

No intervention will be done

Paracetamol infusion

Drug

Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.

Ketorolac analgesia

Drug

In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.

Fentanyl

Drug

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.

Primary outcomes

  1. Cumulative postoperative fentanyl consumption (total dose given in micrograms)

    Time frame: For 24 hours after surgery

Secondary outcomes

  1. Cumulative intraoperative fentanyl consumption (total dose given in micrograms)

    Time frame: For 4 hours after start of anaesthesia

    Cumulative use of fentanyl during intra-operative period

  2. Heart rate

    Time frame: For 4 hours after start of anaesthesia

    Changes in intra-operative heart rate values

  3. Mean arterial blood pressure (mmHg)

    Time frame: For 4 hours after start of anaesthesia

    Changes in intra-operative mean arterial blood pressure values

  4. Dermatomal distribution of the extent of the blockade will be assessed by pinprick method

    Time frame: the first one hour after surgery

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

  5. Postoperative pain severity will be assessed using VAS

    Time frame: For 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

  6. Time for the first request to rescue analgesia (in minutes)

    Time frame: For 24 hours after surgery

    Time for first request to rescue analgesia

  7. length of stay at PACU (in minutes)

    Time frame: For 24 hours after surgery

  8. Incidence of postoperative nausea and vomiting

    Time frame: For 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 27, 2017
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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