Trans-incisional vs Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 10 - 21 |
| Updated: | 11/17/2018 |
| Start Date: | June 2015 |
| End Date: | October 2019 |
Trans-incisional Rectus Sheath Block Versus Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy: A Prospective, Randomized Study
This is a prospective, double-blinded, randomized controlled study comparing the efficacy of
trans-incisional rectus sheath block to laparoscopic guided rectus sheath block for pediatric
single-incision laparoscopic cholecystectomy (SILC). umbilical hernia repair in children.
Patients aged 10-21 years old undergoing SILC for cholelithiasis, cholecystitis, or biliary
dyskinesia will be screened for study inclusion. Eligible patients and their
parents/guardians will be approached and, if agreeable, consented for the study
pre-operatively. Patients will be randomized to receive either trans-incisional rectus sheath
block or intra-operative rectus sheath block under direct laparoscopic visualization. Both
will be done by the attending pediatric surgeon. The patient, patient guardians, select
research team members, and PACU staff will be blinded to the method of analgesic
administration.
trans-incisional rectus sheath block to laparoscopic guided rectus sheath block for pediatric
single-incision laparoscopic cholecystectomy (SILC). umbilical hernia repair in children.
Patients aged 10-21 years old undergoing SILC for cholelithiasis, cholecystitis, or biliary
dyskinesia will be screened for study inclusion. Eligible patients and their
parents/guardians will be approached and, if agreeable, consented for the study
pre-operatively. Patients will be randomized to receive either trans-incisional rectus sheath
block or intra-operative rectus sheath block under direct laparoscopic visualization. Both
will be done by the attending pediatric surgeon. The patient, patient guardians, select
research team members, and PACU staff will be blinded to the method of analgesic
administration.
Regional anesthesia has been increasingly utilized for providing post-operative analgesia for
a number of surgical procedures in children. Rectus sheath block and local anesthetic
infiltration of the surgical site are two common modes for providing post-operative
analgesia. Studies comparing the two modes have shown ultrasound-guided rectus sheath block
to improve immediate pain scores and reduce use of post-operative analgesia in pediatric
patients undergoing umbilical hernia repair. However, these studies have compared
pre-incisional ultrasound-guided rectus sheath block to post-operative local anesthetic
infiltration as a subcutaneous and/or intradermal injection. Also, to our knowledge, there
are no studies evaluating the use or efficacy of laparoscopic guided rectus sheath block for
pediatric single-incision laparoscopic surgery. Single-incision surgery involves performing
abdominal operations though a single, small incision, usually located at the umbilicus.
The purpose of this study is to compare the efficacy of trans-incisional rectus sheath block
to intra-operative infiltration of the rectus sheath under direct laparoscopic visualization
via an intra-abdominal approach for providing post-operative analgesia following
single-incision laparoscopic cholecystectomy (SILC) in children.
The investigators propose a prospective study where pediatric patients who are undergoing
single-incision laparoscopic cholecystectomy will be randomized pre-operatively to receive
either a trans-incisional rectus sheath block after facial closure but prior to skin closure
or intra-operative infiltration of the rectus sheath under direct laparoscopic visualization
after cholecystectomy. The primary outcome is the post-operative pain rating based on the
Wong-Baker Faces Pain Rating Scale (WBFPRS) following SILC. Additional outcomes measured will
include: operative times, the use of intravenous/oral opioid and/or non-opioid medication in
the post-operative period, duration of analgesia following surgery based on time to first
rescue analgesic, intra-operative hemodynamic changes, post-operative hemodynamic changes,
incidence of side-effects, and complications. Patients/patient guardians will receive a sheet
to document post-operative WBFPRS scores, oral opioid and non-opioid medication
administration once discharged to home for a total of 5 days.
a number of surgical procedures in children. Rectus sheath block and local anesthetic
infiltration of the surgical site are two common modes for providing post-operative
analgesia. Studies comparing the two modes have shown ultrasound-guided rectus sheath block
to improve immediate pain scores and reduce use of post-operative analgesia in pediatric
patients undergoing umbilical hernia repair. However, these studies have compared
pre-incisional ultrasound-guided rectus sheath block to post-operative local anesthetic
infiltration as a subcutaneous and/or intradermal injection. Also, to our knowledge, there
are no studies evaluating the use or efficacy of laparoscopic guided rectus sheath block for
pediatric single-incision laparoscopic surgery. Single-incision surgery involves performing
abdominal operations though a single, small incision, usually located at the umbilicus.
The purpose of this study is to compare the efficacy of trans-incisional rectus sheath block
to intra-operative infiltration of the rectus sheath under direct laparoscopic visualization
via an intra-abdominal approach for providing post-operative analgesia following
single-incision laparoscopic cholecystectomy (SILC) in children.
The investigators propose a prospective study where pediatric patients who are undergoing
single-incision laparoscopic cholecystectomy will be randomized pre-operatively to receive
either a trans-incisional rectus sheath block after facial closure but prior to skin closure
or intra-operative infiltration of the rectus sheath under direct laparoscopic visualization
after cholecystectomy. The primary outcome is the post-operative pain rating based on the
Wong-Baker Faces Pain Rating Scale (WBFPRS) following SILC. Additional outcomes measured will
include: operative times, the use of intravenous/oral opioid and/or non-opioid medication in
the post-operative period, duration of analgesia following surgery based on time to first
rescue analgesic, intra-operative hemodynamic changes, post-operative hemodynamic changes,
incidence of side-effects, and complications. Patients/patient guardians will receive a sheet
to document post-operative WBFPRS scores, oral opioid and non-opioid medication
administration once discharged to home for a total of 5 days.
Inclusion Criteria:
- Patients aged 10-21 years old undergoing single-incision laparoscopic cholecystectomy
Exclusion Criteria:
- Patients with choledocolithiasis, gallstone pancreatitis, or sickle cell disease
- Allergy to bupivacaine
- Concurrent surgical procedure
- Developmental delay or neurologic diagnosis that would interfere with post- operative
pain score assessment
- Chronic pain medication use, chronic pain disorder or complex regional pain syndrome
- Anesthesiologist classification of III or greater
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