Nerve Blocks vs Local Injections for Post-op Pain Prevention in Laparoscopic Cholecystectomy in Children
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 8 - 17 |
| Updated: | 5/5/2018 |
| Start Date: | January 6, 2017 |
| End Date: | January 2021 |
Transversus Abdominis Plane Block vs. Local Wound Infiltration for Elective Laparoscopic Cholecystectomy in Children and Adolescents: A Prospective Randomized-Controlled Trial
The objective of this study is to compare transversus abdominis plane (TAP) blocks to local
wound infiltration (LWI) in terms of postoperative pain control in pediatric patients
undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be
superior to LWI for postoperative pain control resulting in decreased use of opioid /
narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative
period. The rationale is that determining the effect of analgesia in this pediatric
population is important to optimize clinical care.
wound infiltration (LWI) in terms of postoperative pain control in pediatric patients
undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be
superior to LWI for postoperative pain control resulting in decreased use of opioid /
narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative
period. The rationale is that determining the effect of analgesia in this pediatric
population is important to optimize clinical care.
In this study, patients ages 8 through 17 years scheduled for elective laparoscopic
cholecystectomy will be invited to participate. Those having da Vinci cholecystectomy
procedures will also be eligible. The da Vinci System is a minimally invasive option
utilizing robotic technology. Once randomized, the patient will undergo either ultrasound
guided bilateral TAP blocks or LWI at the beginning of the surgical procedure. Prospective
data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will
be collected for both groups. Due to the nature of the study, it will not be possible to
blind the investigators to the randomly selected method of injecting local anesthesia;
however the personnel involved in the post-anesthetic and post-operative assessment will be
blinded to the intervention, as well as the subjects themselves.
cholecystectomy will be invited to participate. Those having da Vinci cholecystectomy
procedures will also be eligible. The da Vinci System is a minimally invasive option
utilizing robotic technology. Once randomized, the patient will undergo either ultrasound
guided bilateral TAP blocks or LWI at the beginning of the surgical procedure. Prospective
data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will
be collected for both groups. Due to the nature of the study, it will not be possible to
blind the investigators to the randomly selected method of injecting local anesthesia;
however the personnel involved in the post-anesthetic and post-operative assessment will be
blinded to the intervention, as well as the subjects themselves.
Inclusion Criteria:
1. 8-17 yrs of age at date of enrollment.
2. Elective laparoscopic or da Vinci cholecystectomy scheduled for any diagnostic reason.
Exclusion Criteria:
1. Chronic pain or chronic use of narcotic or other prescription pain medications.
2. Use of pain medication within 24 hours before surgery
3. Prior major abdominal surgery
4. Evidence of acute inflammation
5. Patients with acute cholecystitis
6. Bleeding / coagulation disorder
7. Seizure disorder
8. Renal dysfunction
9. Infection at injection sites for TAP block or trocar placement
10. Contraindication to LWI or TAP block procedure, as determined by surgeon or
anesthesiologist performing the procedure (including, but not limited to, previous
incision distorting anatomy or inability to visualize anatomical planes)
11. Any known allergy to medications used in this study
12. Patient unable to verbalize pain score or independently assess pain level
13. Unstable patient in need of emergent intervention at surgeon discretion
14. Patients who are known to be pregnant
15. Patients who are currently prisoners
16. Children in custody of the state
17. Subjects will a BMI >/= 50
18. Investigator discretion for any other reason
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