Laparoscopic TAP Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain

Prostate Cancer Clinical Trial

— TAPBlock  

Official title:

Perioperative Laparoscopic Transversus Abdominis Plane Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05753046
• Other study ID #: 2022-235
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: February 19, 2024
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine the impact of a laparoscopic-guided transversus abdominis plane (TAP) block timing (at initiation or conclusion of procedure) on the postoperative pain experience in patients following robot assisted laparoscopic radical prostatectomy (RALP).

Description:

TAP block involves the use of a local anesthetic agent injected between the internal oblique and transversus abdominis muscles for the goal of pain relief. Often times these are performed under ultrasound guidance by the anesthesiology team preoperatively. The idea behind this is to provide a neurologic block to the sensory nerve fibers supplying the anterior abdominal wall, between the internal oblique and transversus abdominis muscles. More recently, this technique has been investigated in the setting of robot-assisted laparoscopic radical prostatectomy (RALP) with promising results. There is a lack of data comparing the benefits of the timing of TAP block, and whether performing this at the initiation versus conclusion of the case provides superior results This is a prospective, randomized controlled trial of subjects undergoing early versus late TAP block for the management of postoperative pain following RALP. Subjects will be recruited through physician referral from private Urology offices. Potential subjects (patients scheduled for RALP procedure) will be approached by the study doctor prior to surgery, either in the study doctor's office or in the pre-operative area. Subjects who meet all the eligibility criteria will be enrolled in the study and randomized (1:1) to receive early or late surgeon performed laparoscopic TAP block. Each patient will only receive one treatment (TAP block) either at the initiation or conclusion of his procedure. For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone either at the initiation of the procedure (immediately following placement of the robotic / laparoscopic camera port) or at the conclusion of the procedure (immediately proceeding removal of the robotic / laparoscopic camera port). Study doctors will use laparoscopic / robotic camera visual aid to confirm positioning between the internal oblique and transversus abdominis muscles for the goal of pain relief.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 94
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able to read, understand, and provide written, dated, informed consent prior to screening, complete study form(s) independently, comply with study protocol, and communicate with study personnel about clinically important information.

2. Men = 18 years of age.

3. Pathologically confirmed diagnosis of prostate cancer

4. Scheduled for routine RALP

Exclusion Criteria:

1. Chronic opioid use (daily for >3 months)

2. Weight <40 kilograms

3. ASA score of V or higher

4. Any condition that causes a lack of normal sensation to the abdomen or pelvis

5. Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation

Related Conditions & MeSH terms

• Pain, Postoperative
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Early TAP Block
For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone at the initiation of the procedure (immediately following placement of the robotic / laparoscopic camera port). The TAP block will be performed with 15 mL 2 finger breadths subcostal at the mid-clavicular line and then 15 mL at the level of the umbilicus along the mid-axillary line on each side. Laparoscopic / robotic camera will be used as a visual aid to confirm positioning between the internal oblique and transversus abdominis muscles for the goal of pain relief.
• Late TAP Block
For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone at the conclusion of the procedure (immediately proceeding removal of the robotic / laparoscopic camera port). The TAP block will be performed with 15 mL 2 finger breadths subcostal at the mid-clavicular line and then 15 mL at the level of the umbilicus along the mid-axillary line on each side. Laparoscopic / robotic camera will be used as a visual aid to confirm positioning between the internal oblique and transversus abdominis muscles for the goal of pain relief.

Locations

Country	Name	City	State
United States	Beaumont Hospital - Royal Oak	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare laparoscopic-guided TAP block timing (at initiation "early" or conclusion "late" of procedure) on the postoperative pain levels reported in patients following robot assisted laparoscopic radical prostatectomy (RALP).	Comparison of patient reported pain scales, based on a score from 0 to 10. Where 0 is no pain and 10 is the worst pain.	24 hours after RALP
Secondary	Compare the effects of TAP Block timing on total opioid consumption	Total opioid consumption will be calculated in morphine equivalent dose (MED).	7 days after RALP with TAP Block
Secondary	Compare the effects of TAP Block timing on hospital length of stay	Total number of days hospitalized from day of procedure to day of discharge home. Reported in number of days.	7 days after RALP with TAP Block
Secondary	Compare the effects of TAP Block timing on return of bowel function	When the patient reports the occurrence of the first bowel movement following the procedure. Reported in number of days.	7 days after RALP with TAP Block
Secondary	Compare the effects of TAP Block timing on postoperative nausea/vomiting	Total number of patient reported occurrences of nausea/vomiting documented in the medical record.	7 days after RALP with TAP Block
Secondary	Compare the effects of TAP Block timing on ambulation	The time in hours reported after the first recorded ambulation post procedure in the medical record.	7 days after RALP with TAP Block
Secondary	Compare the effects of TAP Block timing on readmission for pain	The time in days following discharge to readmission with the rationale for admission noted as pain.	7 days after RALP with TAP Block
Secondary	Compare the safety and tolerability of laparoscopic TAP block.	Safety and tolerability of laparoscopic TAP Block will be assessed in relation to the incidence of adverse events reported.	7 days after RALP with TAP Block