Pain, Postoperative Clinical Trial
Official title:
Pilot Study: Rectus Sheath Blocks for Improving Abdominal Surgery Conditions: A Prospective Randomized Double-Blind Placebo Controlled Study
The purpose of this study is to show that the use of preoperative rectus sheath blocks can ultimately alleviate the need for using nondepolarizing muscle relaxants during certain abdominal procedures.
The patients in the active group will be taken to the operating room and standard american
society of anesthesiologists monitors will be applied. After induction of general anesthesia,
the ultrasonographic anatomy of the umbilical region will be studied in each patient. The
probe will be adjusted until optimum view of both rectus abdominis muscles, their sheaths and
surrounding structures are identified. Once the umbilical region anatomy has been identified
the puncture sites will be determined. The puncture sites will be aseptically prepped, the
ultrasound probed will be covered with a sterile tegaderm, and sterile ultrasound gel will be
used on the field. A 21-g EchoStim echogenic needle will be used. The needle will be inserted
in the long axis parallel to the ultrasound probe. The needle will be advanced carefully
until the needle tip is seen between the posterior aspect of the rectus muscle and its
sheath. After a confirmed negative aspiration, 15 ml of 0.25% bupivacaine will be inserted in
2 ml increments, aspirating in between.
The placebo group will have the exact same procedure performed except 15 ml of normal saline
will be injected in each rectus sheath instead of 0.25% bupivacaine. For all patients, when
the block has been completed the surgery team will then prep the patient and proceed with the
planned operation. The surgery staff and anesthesia providers taking care of the patient in
the operating room will be unaware of the patient's group. At this point, all patients will
be treated exactly the same. For intubation purposes, all patients will only receive
succinylcholine. After intubation, elimination of the succinylcholine dose will be determined
using a twitch monitor on the ulnar nerve. If at any point during the surgery, the surgery
team needs more muscle relaxation then the anesthesia staff will give appropriate
medications.
The first step will be to administer propofol 50mg IV, if hemodynamics allow, and to verify
that the patient has 1.0-1.2 minimum alveolar concentration (MAC) of volatile anesthetic. If
the patient is not at 1.0 MAC, then the volatile anesthetic should be increased. If this does
not provide sufficient relaxation, then a nondepolarizing muscle relaxant will be given in
10mg increments titrated to a train of four of 2 twitches at the ulnar nerve. All patients
will receive ofirmev and fentanyl in the operating room for pain control. Ofirmev 1000mg will
be given pre-incision to each patient and 1.5 mcg/kg loading dose of fentanyl will be given
to each patient. Fentanyl will be redosed in 50mcg increments for a 20% increase in blood
pressure or heart rate above preinduction values that is sustained for 5 minutes despite an
adequate depth of anesthesia, defined as 1 MAC or greater.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05480111 -
The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy
|
Phase 4 | |
Completed |
NCT06129305 -
Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
|
||
Completed |
NCT04401826 -
Micro-surgical Treatment of Gummy Smile
|
N/A | |
Recruiting |
NCT04020133 -
the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction.
|
N/A | |
Completed |
NCT03023462 -
Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
|
N/A | |
Completed |
NCT03546738 -
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery
|
N/A | |
Completed |
NCT03652103 -
Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy
|
Phase 4 | |
Terminated |
NCT03261193 -
ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain
|
Phase 3 | |
Withdrawn |
NCT03528343 -
Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
|
Phase 1/Phase 2 | |
Completed |
NCT02525133 -
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
|
Phase 3 | |
Completed |
NCT03244540 -
Regional Analgesia After Cesarean Section
|
Phase 4 | |
Enrolling by invitation |
NCT05316168 -
Post Operative Pain Management for ACL Reconstruction
|
Phase 3 | |
Recruiting |
NCT04130464 -
Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
|
Phase 4 | |
Enrolling by invitation |
NCT04574791 -
Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
|
N/A | |
Completed |
NCT04073069 -
Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults
|
Phase 4 | |
Completed |
NCT04526236 -
Influence of Aging on Perioperative Methadone Dosing
|
Phase 4 | |
Recruiting |
NCT05351229 -
Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery
|
Phase 4 | |
Enrolling by invitation |
NCT05543109 -
Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block
|
N/A | |
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04919317 -
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
|
Phase 2 |