Bupivacaine Hydrochloride 0.25% Injection Solution
Drug10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
Other names: Bupivacaine
NCT Number: NCT03283436
The goal of this study is to assess the efficacy of a superior hypogastric plexus block (SHPB) for pain relief following a laparoscopic hysterectomy.
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Notify Me18 year and older
Female
Interventional
Phase 4
Brigham & Women's Hospital, Boston, Massachusetts, United States
The objective of this study is to assess the efficacy of a SHPB for pain relief following laparoscopic hysterectomy. The superior hypogastric plexus lies in the presacral space and supplies autonomic innervation to the central pelvis. This plexus is suspected to play a role in postoperative pain following a hysterectomy. The investigators hypothesize that a SHPB using the anesthetic bupivacaine will reduce patients' pain scores and opioid consumption following a laparoscopic hysterectomy. Intraoperative and immediate postoperative opioid consumption will be collected from the Medication Administration Record by the nursing staff. The nursing staff will also be asked to complete a recovery worksheet that details the Visual Analog Scale pain score and opioid administration on admission to the recovery unit and every postoperative hour until six hours or the patient is discharged. Patients will also be asked to complete a daily diary for one week following the procedure, which details their pain level and daily opioid consumption. Patients will be followed for thirty days after surgery to assess for the occurrence of any postoperative complications. Detailed patient and procedure characteristics including age, race, body mass index, parity, surgical history, surgery indication, procedure type, and surgical approach will also be collected.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
Other names: Bupivacaine
Time frame: Admission to recovery unit and every hour after for 2 hours
The primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours.
Time frame: Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery
Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.
Time frame: Discharge to 1 week after surgery, assessed up to 1 week after surgery
Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.
Jon I. Einarsson
Other
Superior Hypogastric Plexus Block During Laparoscopic Hysterectomy: a Randomized Controlled Trial.
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