BACKGROUND: To assess whether patient comfort could be increased by adding procedural sedation and analgesia (PSAA) to periprostatic nerve block (PNB) in patients undergoing transrectal ultrasound-guided prostatic biopsy (TRUS-PB). METHODS: This was a prospective, randomized (1:2) trial comparing PNB with the combination of PSAA+PNB in patients undergoing TRUS-PB. PNB was achieved by using lidocaine gel and lidocaine and bipuvacaine infiltration. PSAA-treated patients received midazolam and remifentanil. All biopsies were standardized and performed in a fully equipped endourology suite. PSAA was delivered by an anesthesiology nurse in the presence and availability of an anesthesiologist. An orally administered numeric scale of 0-10 was used to assess the patient's pain, and a visual scale of 0-4 was used to quantify their satisfaction. Pain and satisfaction scores were compared between the groups. RESULTS: Data on 331 patients were analyzed: 235 received PNB, and 96 receivedPSAA+PNB. Distribution within the groups by age, prostate-specific antigen serum levels, prostate volume, and number of cores obtained was similar. Airway insertion was required in 4 of 96 patients in PSAA+PNB arm (4%), with no other complications related to sedation. The average pain level was significantly lower in the PSAA+PNB group than it was in the PNB group (0.88 versus 1.31; p = 0.008). The satisfaction level was high (3.5) and alike in the two groups; however, significantly more patients reported a perfect score of 4 in the PSAA+PNB arm (p = 0.03). CONCLUSIONS:PSAA with midazolam and remifentanil used as an adjunct to the standard PNB is safe and effective during TRUS-PB. Patients undergoing PSAA in addition to PNB experienced significantly less pain and higher satisfaction scores than did those given PNB alone.
RCT Entities:
BACKGROUND: To assess whether patient comfort could be increased by adding procedural sedation and analgesia (PSAA) to periprostatic nerve block (PNB) in patients undergoing transrectal ultrasound-guided prostatic biopsy (TRUS-PB). METHODS: This was a prospective, randomized (1:2) trial comparing PNB with the combination of PSAA+PNB in patients undergoing TRUS-PB. PNB was achieved by using lidocaine gel and lidocaine and bipuvacaine infiltration. PSAA-treated patients received midazolam and remifentanil. All biopsies were standardized and performed in a fully equipped endourology suite. PSAA was delivered by an anesthesiology nurse in the presence and availability of an anesthesiologist. An orally administered numeric scale of 0-10 was used to assess the patient's pain, and a visual scale of 0-4 was used to quantify their satisfaction. Pain and satisfaction scores were compared between the groups. RESULTS: Data on 331 patients were analyzed: 235 received PNB, and 96 received PSAA+PNB. Distribution within the groups by age, prostate-specific antigen serum levels, prostate volume, and number of cores obtained was similar. Airway insertion was required in 4 of 96 patients in PSAA+PNB arm (4%), with no other complications related to sedation. The average pain level was significantly lower in the PSAA+PNB group than it was in the PNB group (0.88 versus 1.31; p = 0.008). The satisfaction level was high (3.5) and alike in the two groups; however, significantly more patients reported a perfect score of 4 in the PSAA+PNB arm (p = 0.03). CONCLUSIONS:PSAA with midazolam and remifentanil used as an adjunct to the standard PNB is safe and effective during TRUS-PB. Patients undergoing PSAA in addition to PNB experienced significantly less pain and higher satisfaction scores than did those given PNB alone.