Carlo Saccardi1, Salvatore Gizzo1, Amerigo Vitagliano2, Marco Noventa1, Massimo Micaglio3, Matteo Parotto4, Mauro Fiorese5, Pietro Litta1. 1. Department of Woman and Child Health, University of Padua, Giustiniani 3, 35128, Padua, Italy. 2. Department of Woman and Child Health, University of Padua, Giustiniani 3, 35128, Padua, Italy. amerigovitagliano.md@gmail.com. 3. Department of Anesthesia and Intensive Care, Careggi University Hospital, Florence, Italy. 4. Department of Anesthesia, Toronto General Hospital, University of Toronto, Toronto, ON, Canada. 5. Dipartimento Materno Infantile U.O.C. di Ostetricia e Ginecologia, U.L.S.S. N. 4 Alto Vicentino, Thiene, Italy.
Abstract
BACKGROUND: A proportion of patients undergoing laparoscopic gynecological surgery experiences excessive post-operative pain, which results in high rescue analgesic treatment and prolonged hospitalization. The aim of our study was to evaluate the efficacy of intraoperative topical ropivacaine in the control of post-operative pain in the first 48 h after operative laparoscopy for benign adnexal or uterine pathologies . METHODS: We conducted a prospective, randomized, double-blind, placebo-controlled clinical trial. Patients received a standard dose of topical ropivacaine (injected at the three portal sites and atomized in the abdominal cavity) or placebo. The primary outcome was the evaluation of post-operative pain intensity 6 h after surgery. Secondary outcomes included the intensity of pain during the 48 h after surgery, shoulder tip pain and the request for rescue analgesics during the first 48 h after surgery, time to discharge from recovery room, time to mobilizing on the ward and time to return to daily activities. Patients were divided in two groups (Group_A: benign adnexal pathologies; Group_B: benign uterine diseases) and assigned to Subgroup_1 (receiving ropivacaine) and Subgroup_2 (receiving placebo). RESULTS:A total of 187 women were included: 93 in Group_A and 94 inGroup_B. Forty-seven patients entered Subgroup_A1, 46 Subgroup_A2, 48 Subgroup_B1 and 46 Subgroup_B2. Subgroup_A1 experienced lower post-operative pain at 4 (p = 0.008) and 6 h (p = 0.001) as well as a faster return to daily activities (p = 0.01) in comparison with Subgroup_A2. Both Subgroup_A1 and Subgroup_B1 showed lower shoulder tip pain (respectively, p = 0.032 and p = 0.001) as well as shorter time to mobilizing on the ward after surgery (respectively, p = 0.001 and p = 0.01). The remaining variables analysis did not show significant results. CONCLUSIONS: Combined topical analgesia with ropivacaine could represent a new safe and effective tool in the control of post-operative pain in gynecological laparoscopic surgery. Given the greater benefits for adnexal surgery, this strategy may be more suitable for this class of patients.
RCT Entities:
BACKGROUND: A proportion of patients undergoing laparoscopic gynecological surgery experiences excessive post-operative pain, which results in high rescue analgesic treatment and prolonged hospitalization. The aim of our study was to evaluate the efficacy of intraoperative topical ropivacaine in the control of post-operative pain in the first 48 h after operative laparoscopy for benign adnexal or uterine pathologies . METHODS: We conducted a prospective, randomized, double-blind, placebo-controlled clinical trial. Patients received a standard dose of topical ropivacaine (injected at the three portal sites and atomized in the abdominal cavity) or placebo. The primary outcome was the evaluation of post-operative pain intensity 6 h after surgery. Secondary outcomes included the intensity of pain during the 48 h after surgery, shoulder tip pain and the request for rescue analgesics during the first 48 h after surgery, time to discharge from recovery room, time to mobilizing on the ward and time to return to daily activities. Patients were divided in two groups (Group_A: benign adnexal pathologies; Group_B: benign uterine diseases) and assigned to Subgroup_1 (receiving ropivacaine) and Subgroup_2 (receiving placebo). RESULTS: A total of 187 women were included: 93 in Group_A and 94 in Group_B. Forty-seven patients entered Subgroup_A1, 46 Subgroup_A2, 48 Subgroup_B1 and 46 Subgroup_B2. Subgroup_A1 experienced lower post-operative pain at 4 (p = 0.008) and 6 h (p = 0.001) as well as a faster return to daily activities (p = 0.01) in comparison with Subgroup_A2. Both Subgroup_A1 and Subgroup_B1 showed lower shoulder tip pain (respectively, p = 0.032 and p = 0.001) as well as shorter time to mobilizing on the ward after surgery (respectively, p = 0.001 and p = 0.01). The remaining variables analysis did not show significant results. CONCLUSIONS: Combined topical analgesia with ropivacaine could represent a new safe and effective tool in the control of post-operative pain in gynecological laparoscopic surgery. Given the greater benefits for adnexal surgery, this strategy may be more suitable for this class of patients.
Authors: Perla Ekstein; Amir Szold; Boaz Sagie; Nachum Werbin; Joseph M Klausner; Avi A Weinbroum Journal: Ann Surg Date: 2006-01 Impact factor: 12.969
Authors: Carlo Saccardi; Amerigo Vitagliano; Matteo Marchetti; Alice Lo Turco; Sofia Tosatto; Michela Palumbo; Luciana Serena De Lorenzo; Salvatore Giovanni Vitale; Marco Scioscia; Marco Noventa Journal: Diagnostics (Basel) Date: 2020-04-27
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