Clinical trial NCT06655298: Ultrasound Guided Erector Spinae Block Versus Quadratus Lumborum Block For Postoperative Pain ReliefFollowing Laparoscopic Nephrectomy
Official title: Ultrasound Guided Erector Spinae Block Versus Quadratus Lumborum Block For Postoperative Pain Relief After Laparoscopic Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: erector spinae block
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Patients will be randomized into two groups using a closed envelope technique in sequentially numbered opaque envelopes that will be opened before carrying out the block
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to assess the efficacy of Ultrasound guided erector spinae plane block versus quadratus lumborum block for postoperative analgesia in patient undergoing laparoscopic nephrectomy.

Detailed description: The study will be a prospective randomized single-blind study. Patients will be randomized into two groups using a closed envelope technique in sequentially numbered opaque envelopes that will be opened before carrying out the block

The study will be conducted on 56 patients, 28 patients in each group:

Group Q; (28 patients) Quadratus lumborum block group; patients will receive general anesthesia initially then bilateral QLB type III (anterior subcoastal approach) with a volume of 30 mL of bupivacaine 0.25% for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg) .

✓ Group E; (28 patients) Erector spinae plane block; patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 0.25 % for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg)

Data Collection:

Baseline:

1. Patient demographic data
2. Hemodynamics (pulse- heart rate- mean blood pressure), baseline before induction of anesthesia.

Intraoperative:

1. Hemodynamics (pulse- heart rate- mean blood pressure):

   They will be monitored and recorded 5 minutes after induction of anesthesia then every 30 min till end of the surgery.
2. Total analgesic consumption needed to reach target Entropy measurement 40-60%.
3. The anesthetic time (it is the time that starts when the anesthesia provider begins to administer the IV anesthetics and ends with tracheal extubation) and surgical time (starts with skin incision and ends with last suture and putting dressings on).
4. The time taken to perform the block.
5. Number of patients needed ephedrine and/or atropine and total amount of their administration will be recorded.
6. Recovery time (time since anesthetics discontinuation till reaching score 9 of Alderete's criteria).

Postoperative:

1. Time of first call for rescue analgesia.
2. Number of patients requested analgesia postoperative.
3. Visual analogue scale (VAS) on admission to post-anesthetic care unit (PACU), every 30 minutes for next 2 hours, every 2 hours for next 6 hours and every 4 hours for the rest of the 24 hours postoperatively.

   * Discharge from PACU will be according to Postanesthesia Discharge Scoring System\[14\](Appendix3).
4. Hemodynamics (pulse- heart rate- mean blood pressure)

   They will be assessed as follow:

   • On admission to post-anesthetic care unit (PACU) then every 30 minutes at 30, 60, 90, 120 minutes then every 2 hours for next 6 hours then every 6 hours for remaining 24 hours.
5. Vomiting, nausea and starting time of intestinal movements.
6. Duration of the block (from the injection time of local anesthetic till complete return of sensation).

Eligibility criteria: Inclusion Criteria:

* ASA I, II, III scheduled for laparoscopic nepheroctomy

Exclusion Criteria:

* patient refusal bleeding disorders neurological and psychological diseases

Primary outcomes:
measure: analgesia
timeFrame: 1 year
Secondary outcomes:
measure: time
timeFrame: 1 year
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University
Study officials:
affiliation: lectuerer of anathesia
name: Asmaa mohamed H Sedky
role: STUDY_DIRECTOR
References: