Laparoscopic Cholecystectomy Clinical Trial
Official title:
Analgesic Efficacy of Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy
Verified date | April 2018 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University | Mansourah | DK |
Egypt | Mansoura University, Faculty of Medicine | Mansourah | DK |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
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 |
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