Skip to content

Trans-incisional vs Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy

Trans-incisional Rectus Sheath Block Versus Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy: A Prospective, Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02494336
Enrollment
48
Registered
2015-07-10
Start date
2015-06-30
Completion date
2019-10-31
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Brief summary

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 Post anesthesia care unit (PACU) staff will be blinded to the method of analgesic administration.

Detailed description

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.

Interventions

PROCEDURETrans-incisional rectus sheath block

After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.

PROCEDURELaparoscopic guided rectus sheath block

After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.

DRUGRopivacaine

Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.

Sponsors

Johns Hopkins All Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post Operative Pain Rating5 daysUsing the Wong-Baker FACES Pain Rating Scale (WBFPRS). The WBFPRS is a visual pain rating scale in which the participant looks at pictures of faces depicting levels of pain and chooses the one that most closely resembles their own pain. The scale ranges from 0 no hurt to 10 Hurts Worst.

Secondary

MeasureTime frameDescription
Use of Post-operative Intravenous/Oral Opioid and Non-opioid5 daysAmount of postoperative intravenous/oral opioid and non-opioid medications received by patient. This is being recorded as Morphine milligram equivalents (MME)/kilogram(kg) for days 1-5.
Time to First Rescue Analgesic1 dayAmount of time in minutes until the first analgesic is given postoperatively.
Operative Time1 dayOperative time is measured as the time between X and Y. Reported in minutes.
Number of Participants With Complications30 daysNumber of participants with complications such as infection, bleeding, intravascular injection, bowel puncture.
Total Number of Complications30 daysTotal number of complications such as infection, bleeding, intravascular injection, bowel puncture.
Number of Participants With Side Effects5 daysNumber of participants with side effects such as nausea, vomiting, allergic reactions.

Countries

United States

Participant flow

Participants by arm

ArmCount
Trans-incisional Rectus Sheath Block
rectus sheath block under direct visualization through the umbilical incision by the attending surgeon Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision. Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
24
Laparoscopic Guided Rectus Sheath Block
rectus sheath block under direct laparoscopic visualization by the attending surgeon Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon. Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
24
Total48

Baseline characteristics

CharacteristicLaparoscopic Guided Rectus Sheath BlockTotalTrans-incisional Rectus Sheath Block
Age, Continuous14.83 years
STANDARD_DEVIATION 4
15.33 years
STANDARD_DEVIATION 3.06
15.83 years
STANDARD_DEVIATION 1.63
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
24 Participants48 Participants24 Participants
Sex: Female, Male
Female
20 Participants38 Participants18 Participants
Sex: Female, Male
Male
4 Participants10 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 24
other
Total, other adverse events
0 / 240 / 24
serious
Total, serious adverse events
2 / 241 / 24

Outcome results

Primary

Post Operative Pain Rating

Using the Wong-Baker FACES Pain Rating Scale (WBFPRS). The WBFPRS is a visual pain rating scale in which the participant looks at pictures of faces depicting levels of pain and chooses the one that most closely resembles their own pain. The scale ranges from 0 no hurt to 10 Hurts Worst.

Time frame: 5 days

ArmMeasureValue (MEAN)Dispersion
Trans-incisional Rectus Sheath BlockPost Operative Pain Rating4.03 score on a scaleStandard Deviation 1.46
Laparoscopic Guided Rectus Sheath BlockPost Operative Pain Rating4.03 score on a scaleStandard Deviation 1.16
Secondary

Number of Participants With Complications

Number of participants with complications such as infection, bleeding, intravascular injection, bowel puncture.

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Trans-incisional Rectus Sheath BlockNumber of Participants With Complications0 Participants
Laparoscopic Guided Rectus Sheath BlockNumber of Participants With Complications0 Participants
Secondary

Number of Participants With Side Effects

Number of participants with side effects such as nausea, vomiting, allergic reactions.

Time frame: 5 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Trans-incisional Rectus Sheath BlockNumber of Participants With Side Effects0 Participants
Laparoscopic Guided Rectus Sheath BlockNumber of Participants With Side Effects0 Participants
Secondary

Operative Time

Operative time is measured as the time between X and Y. Reported in minutes.

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Trans-incisional Rectus Sheath BlockOperative Time62 minutesStandard Deviation 27
Laparoscopic Guided Rectus Sheath BlockOperative Time60 minutesStandard Deviation 19
Secondary

Time to First Rescue Analgesic

Amount of time in minutes until the first analgesic is given postoperatively.

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Trans-incisional Rectus Sheath BlockTime to First Rescue Analgesic14.4 minutesStandard Deviation 11.3
Laparoscopic Guided Rectus Sheath BlockTime to First Rescue Analgesic17.9 minutesStandard Deviation 16.8
Secondary

Total Number of Complications

Total number of complications such as infection, bleeding, intravascular injection, bowel puncture.

Time frame: 30 days

ArmMeasureValue (NUMBER)
Trans-incisional Rectus Sheath BlockTotal Number of Complications0 complications
Laparoscopic Guided Rectus Sheath BlockTotal Number of Complications0 complications
Secondary

Use of Post-operative Intravenous/Oral Opioid and Non-opioid

Amount of postoperative intravenous/oral opioid and non-opioid medications received by patient. This is being recorded as Morphine milligram equivalents (MME)/kilogram(kg) for days 1-5.

Time frame: 5 days

ArmMeasureValue (MEAN)Dispersion
Trans-incisional Rectus Sheath BlockUse of Post-operative Intravenous/Oral Opioid and Non-opioid0.49 MME/kgStandard Deviation 0.32
Laparoscopic Guided Rectus Sheath BlockUse of Post-operative Intravenous/Oral Opioid and Non-opioid056 MME/kgStandard Deviation 0.42

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026