Insignificant influence of the intertransverse process block for major breast cancer surgery: a randomized, blinded, placebo-controlled, clinical trial
IntroductionThe intertransverse process (ITP) block mimics the thoracic paravertebral block and allegedly ameliorates hemithoracic postoperative pain. However, concerning major reconstructive breast cancer surgery the modality has never been tested against placebo in a randomized clinical trial. We aimed to assess the efficacy of the multiple-injection ITP block and hypothesized that the blockade would reduce postoperative opioid consumption. MethodsWe screened 58 patients with breast cancer scheduled for unilateral subpectoral implant-based primary breast reconstruction, involving mastectomy with complete fascial dissection of the major pectoral muscle. A randomization procedure allowed for the allocation of 36 patients to receive either unilateral multiple-injection active ITP block (0.5% ropivacaine 3x10 mL) or placebo ITP block (isotonic saline 3x10 mL) at T2, T4, T6 in a prospective, blinded, clinical trial. The primary outcome was total opioid consumption within the first 24 postoperative hours. Secondary outcomes included opioid consumption at 4-hour intervals, postoperative pain, patient satisfaction with block application, time to first opioid, ambulation and discharge, opioid-related side effects, and quality of recovery. ResultsOpioid consumption within the first 24 postoperative hours showed no significant reduction when comparing the active and placebo group median (IQR): 75.0 mg (45-135) vs 62.5 mg (30-115), p=0.5, respectively. We did not find any consequential clinically relevant results of the secondary outcomes. ConclusionsFollowing major reconstructive breast cancer surgery, a preoperative multiple-injection ITP block neither reduces 24-hour opioid consumption postoperatively nor promotes substantial clinical positive outcomes.
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Bakircay Univ, Dept Anesthesiol, Fav Med, Cigli Training & Res Hosp, Izmir, TurkeyBakircay Univ, Dept Anesthesiol, Fav Med, Cigli Training & Res Hosp, Izmir, Turkey
Aygun, Hakan
Kiziloglu, Ilker
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Bakircay Univ, Dept Gen Surg, Fav Med, Cigli Training & Res Hosp, Izmir, TurkeyBakircay Univ, Dept Anesthesiol, Fav Med, Cigli Training & Res Hosp, Izmir, Turkey
Kiziloglu, Ilker
Ozturk, Nilgun Kavrut
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Univ Hlth Sci, Dept Anesthesiol, Fac Med, Antalya Training & Res Hosp, Antalya, TurkeyBakircay Univ, Dept Anesthesiol, Fav Med, Cigli Training & Res Hosp, Izmir, Turkey
Ozturk, Nilgun Kavrut
Ocal, Haydar
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Bakircay Univ, Fac Med, Dept Gen Oncol Surg, Cigli Training & Res Hosp, Izmir, TurkeyBakircay Univ, Dept Anesthesiol, Fav Med, Cigli Training & Res Hosp, Izmir, Turkey
Ocal, Haydar
Inal, Abdullah
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Bakircay Univ, Dept Gen Surg, Fav Med, Cigli Training & Res Hosp, Izmir, TurkeyBakircay Univ, Dept Anesthesiol, Fav Med, Cigli Training & Res Hosp, Izmir, Turkey
Inal, Abdullah
Kutlucan, Leyla
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Bakircay Univ, Dept Anesthesiol, Fav Med, Cigli Training & Res Hosp, Izmir, TurkeyBakircay Univ, Dept Anesthesiol, Fav Med, Cigli Training & Res Hosp, Izmir, Turkey
Kutlucan, Leyla
Gonullu, Edip
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Bakircay Univ, Fac Med, Dept Anesthesiol Algol, Cigli Training & Res Hosp, Izmir, TurkeyBakircay Univ, Dept Anesthesiol, Fav Med, Cigli Training & Res Hosp, Izmir, Turkey
Gonullu, Edip
Tulgar, Serkan
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Samsun Univ, Samsun Training & Res Hosp, Dept Anesthesiol, Fac Med, Samsun, TurkeyBakircay Univ, Dept Anesthesiol, Fav Med, Cigli Training & Res Hosp, Izmir, Turkey
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Walter Reed Army Med Ctr, Anesthesia & Operat Serv, Def & Vet Pain Management Initiat, Washington, DC 20307 USAWalter Reed Army Med Ctr, Anesthesia & Operat Serv, Def & Vet Pain Management Initiat, Washington, DC 20307 USA
Buckenmaier, Chester C., III
Kwon, Kyung H.
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Walter Reed Army Med Ctr, Anesthesia & Operat Serv, Def & Vet Pain Management Initiat, Washington, DC 20307 USAWalter Reed Army Med Ctr, Anesthesia & Operat Serv, Def & Vet Pain Management Initiat, Washington, DC 20307 USA
Kwon, Kyung H.
Howard, Robin S.
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Walter Reed Army Med Ctr, Dept Clin Invest, Div Biostat, Washington, DC 20307 USAWalter Reed Army Med Ctr, Anesthesia & Operat Serv, Def & Vet Pain Management Initiat, Washington, DC 20307 USA
Howard, Robin S.
McKnight, Geselle M.
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Walter Reed Army Med Ctr, Anesthesia & Operat Serv, Def & Vet Pain Management Initiat, Washington, DC 20307 USAWalter Reed Army Med Ctr, Anesthesia & Operat Serv, Def & Vet Pain Management Initiat, Washington, DC 20307 USA
McKnight, Geselle M.
Shriver, Craig D.
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Walter Reed Army Med Ctr, Clin Breast Care Project, Washington, DC 20307 USA
US Mil Canc Inst, Clin Trials Grp, Washington, DC USAWalter Reed Army Med Ctr, Anesthesia & Operat Serv, Def & Vet Pain Management Initiat, Washington, DC 20307 USA
Shriver, Craig D.
Fritz, William T.
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Conemaugh Mem Med Ctr, Dept Anesthesiol, Johnstown, PA USAWalter Reed Army Med Ctr, Anesthesia & Operat Serv, Def & Vet Pain Management Initiat, Washington, DC 20307 USA
Fritz, William T.
Garguilo, Gerard A.
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Conemaugh Mem Med Ctr, Johnstown Breast Ctr, Johnstown, PA USAWalter Reed Army Med Ctr, Anesthesia & Operat Serv, Def & Vet Pain Management Initiat, Washington, DC 20307 USA
Garguilo, Gerard A.
Joltes, Kristin H.
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Conemaugh Mem Med Ctr, Acute Pain Serv, Johnstown, PA USAWalter Reed Army Med Ctr, Anesthesia & Operat Serv, Def & Vet Pain Management Initiat, Washington, DC 20307 USA
Joltes, Kristin H.
Stojadinovic, Alexander
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Walter Reed Army Med Ctr, Clin Breast Care Project, Washington, DC 20307 USA
US Mil Canc Inst, Clin Trials Grp, Washington, DC USAWalter Reed Army Med Ctr, Anesthesia & Operat Serv, Def & Vet Pain Management Initiat, Washington, DC 20307 USA
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Univ Oklahoma, Hlth Sci Ctr, Dept Otorhinolaryngol, Oklahoma City, OK 73190 USAUniv Oklahoma, Hlth Sci Ctr, Dept Otorhinolaryngol, Oklahoma City, OK 73190 USA
Nease, CJ
Krempl, GA
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Univ Oklahoma, Hlth Sci Ctr, Dept Otorhinolaryngol, Oklahoma City, OK 73190 USAUniv Oklahoma, Hlth Sci Ctr, Dept Otorhinolaryngol, Oklahoma City, OK 73190 USA
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Islamic Azad Univ, Pharmaceut Branch, Tehran, IranUniv Tehran Med Sci, Digest Dis Res Ctr, Tehran, Iran
Mohammadi, Maryam
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Elahi, Elham
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Chaharmahali, Meghedi
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Safarnavadeh, Tahereh
Abdollahi, Mohammad
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Univ Tehran Med Sci, Fac Pharm, Tehran, Iran
Univ Tehran Med Sci, Pharmaceut Sci Res Ctr, Tehran, IranUniv Tehran Med Sci, Digest Dis Res Ctr, Tehran, Iran