Clinical trial NCT02824939: Comparison of Quadratus Lumborum Block With TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy
Official title: Comparison of Ultrasound Guided Quadratus Lumborum Block With Ultrasound Guided TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2016-07-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomised controlled trial which will compare the Quadratus Lumborum (QL) Block with the Transversus Abdominis Plane (TAP) Block in terms of analgesic efficacy, ease of performance and safety when administered postoperatively in patients who undergo laparoscopic nephrectomy.

To fulfill this purpose, three groups of patients each with 32 patients, will be formed. Patients in the Transversus Abdominis Plane (TAP) group and Quadratus Lumborum (QL) group will each receive the respective blocks with 0.4 ml/kg of 0.25% Bupivacaine, after completion of surgery. The third (Control group) will not receive any blocks. After shifting patients to recovery all three groups will be put into intravenous patient controlled analgesia (PCA) Morphine as rescue analgesic regimen as per a set protocol. Morphine consumption over the first postoperative 24 hours, ease of performance of individual blocks and associated adverse events, adverse events associated with opioid use, patient recovery and satisfaction will be noted.


Eligibility criteria: Inclusion Criteria:

* patients between 18-65 years of age,
* ASA class I or II,
* undergoing elective unilateral laparoscopic nephrectomy
* under general anaesthesia

Exclusion Criteria:

Patients with any of the following:

* refusal to participate in the study
* coagulopathy/ thrombocytopenia
* localised infection at the proposed site of injection
* inability to comprehend the scoring systems to be employed or use PCA due to physical or mental problems
* known allergy to the drugs to be used (local anesthetics, opioids)
* opioid tolerance/ dependence
* renal impairment
* hepatic impairment
* known cardio-respiratory impairment
* morbid obesity/ sleep apnoea

Primary outcomes:
measure: Cumulative morphine consumption in 24 hours in milligrams
timeFrame: within the first 24 hours after surgery
Secondary outcomes:
measure: Pain scores at rest and on movement as measured by numeric rating scale (0 to 10)
timeFrame: within the first 24 hours after surgery
measure: Time to first demand of rescue analgesic in hours
timeFrame: within the first 24 hours after surgery
measure: Ease of performing the respective blocks (assessed by time required to perform the blocks in minutes and number of attempts required to perform the blocks)
timeFrame: while performing block
measure: Incidence of block related complications
timeFrame: within the first 24 hours after surgery
measure: Incidence of adverse effects related to opioid use (derrived from incidence of nausea and vomiting, sedation and respiratory depression)
timeFrame: within the first 24 hours after surgery
measure: Patient satisfaction as measured by numeric rating scale (0 to 10)
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
Study officials:
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