Clinical trial NCT02409498: Use of Pre-Emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery
Official title: A Randomized Controlled Trial of Use of Pre-emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pudendal nerve block
vaginal reconstructive surgery
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2015-04-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the effectiveness of perineal pain control via injection of a local anesthetic to numb the pudendal nerve. The medication which is commonly used for this block is called marcaine. This is called a pudendal block it has been used in obstetrical and gynecologic surgeries for several decades. The goal of this study is to reduce the amount of pain medications taken post operatively after pelvic reconstructive surgery. Subjects undergoing pelvic reconstructive surgery will be recruited during the pre-op visit. Subjects will be asked about their pain level in the PACU and also asked to document their pain score days 1 and 2 post op. They will also be asked to keep a medication log for 14 days post op.

Detailed description: Subjects will have a through physical exam with evolution of the pelvis support using the POP-Q (pelvic organ prolapse quantification) system. All subjects will need to sign informed consent pre-approved by the IRB. The subjects, surgeons, and anesthesiologist will all be blinded to the injected material. The OR Scrub nurse will given the envelope at the start of each case and asked to draw the material into a syringe. All subjects will receive general anesthesia. Subjects will be randomized to receive preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine or normal saline to each side. The allocation schedule is computer generated using random-numbers table concealed in opaque envelops. Once the patient receives general anesthesia she will be positioned appropriately in dorsal lithotomy with padded Allan stir ups. 10 ml of Bupivacaine will be injected on either side using the Iowa trumpet pudendal needle drive to direct and guide appropriate position. Aspiration was attempted for every injection to decrease the chance of intravascular infusion.

At the completion of the surgery the subjects will be brought to the PACU for care. Patients are assessed immediately upon arrival to the PACU. The patients are asked their pain level using the VAS pain scale/ modified surgical pain scale at hours 1 and 2 post op. All patients are given a prescription for Vicoprofen 7.5/200mg at their pre-op visit and asked to have it filled prior to their surgery. Patients have the option to go home the same day of surgery as long as their pain is well controlled and they are clinically stable for discharge. Continued pain management and pain scale assessment will be done at 4 hours, and post op day 1 and 2. A medication log will be kept for 2 weeks post op, detailing the number of pain medications taken during that period.

Eligibility criteria: Inclusion Criteria:

* The ability to read and understand English
* Be at least 18 years old
* Symptomatic Stage 2 prolapse

Exclusion Criteria:

* Intolerance to local anesthetics or narcotics
* History of major psychiatric disorder or chronic pain syndrome
* History of substance abuse or current narcotic use

Primary outcomes:
measure: VAS pain scale
timeFrame: up to 2 weeks
Secondary outcomes:
measure: post operative analgesic consumption
timeFrame: up to 2 weeks
measure: adverse effect of the pudendal block
timeFrame: up to 2 weeks
measure: Length of hospital stay
timeFrame: up to 2 weeks
measure: Medical or surgical complications
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mamta Mamik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katz J, Kavanagh BP, Sandler AN, Nierenberg H, Boylan JF, Friedlander M, Shaw BF. Preemptive analgesia. Clinical evidence of neuroplasticity contributing to postoperative pain. Anesthesiology. 1992 Sep;77(3):439-46. doi: 10.1097/00000542-199209000-00006.
citation: Ke RW, Portera SG, Bagous W, Lincoln SR. A randomized, double-blinded trial of preemptive analgesia in laparoscopy. Obstet Gynecol. 1998 Dec;92(6):972-5. doi: 10.1016/s0029-7844(98)00303-2.
citation: Schierup L, Schmidt JF, Torp Jensen A, Rye BA. Pudendal block in vaginal deliveries. Mepivacaine with and without epinephrine. Acta Obstet Gynecol Scand. 1988;67(3):195-7. doi: 10.3109/00016348809004200.