A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair
Given the accelerating opioid crisis in the United States and evidence that patients use fewer opioid tablets than prescribed, surgeons may choose to decrease prescribed quantities. The effect this may have on patient satisfaction with pain control after hospital discharge is unknown. The primary ob...
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| Veröffentlicht in: | American journal of obstetrics and gynecology 2020-10, Vol.223 (4), p.547.e1-547.e12 |
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| container_title | American journal of obstetrics and gynecology |
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| creator | Davidson, Emily R.W. Paraiso, Marie Fidela R. Walters, Mark D. Propst, Katie Ridgeway, Beri Yao, Meng Ferrando, Cecile A. |
| description | Given the accelerating opioid crisis in the United States and evidence that patients use fewer opioid tablets than prescribed, surgeons may choose to decrease prescribed quantities. The effect this may have on patient satisfaction with pain control after hospital discharge is unknown.
The primary objective of this study was to compare patient satisfaction with postoperative pain control between patients receiving a routine or reduced quantity opioid prescription after prolapse repair. Secondary objectives included a comparison of opioid-related side-effects, the number of opioid tablets used, and the number of excess tablets prescribed between these groups.
This was a single-center, unmasked, 2-arm, randomized controlled noninferiority trial of women who underwent a prolapse repair with a planned overnight hospitalization. Patients were assigned randomly to 1 of 2 study arms: routine (28 tablets of oxycodone 5 mg) or reduced (5 tablets) prescription of opioid tablets. Patients were eligible if they were at least 18 years of age and undergoing a prolapse repair with an anticipated overnight hospital stay. Exclusion criteria included a history of chronic pain, preoperative opioid use, intolerance to study medication, or a score of ≥30 on the Pain Catastrophizing Scale. In addition to their opioid prescription, all patients received multimodal pain medications at discharge. Patients were asked to complete 6 weeks of diaries to record pain and medication use. The primary outcome (patient satisfaction) was collected as part of a postoperative survey completed at patients’ routine postoperative visit 6 weeks after surgery. The sample size for noninferiority was calculated at 59 patients per group for a total of 118 patients.
One hundred eighteen patients were assigned randomly; the primary outcome was available for 116. The majority of patients were white, postmenopausal, and nonsmokers; the mean age was 62±10.4 years. The most common surgery was a hysterectomy with native tissue repair (n=71; 60%). One hundred ten patients (93%) were satisfied with postoperative pain control. Statistical analysis constructed for noninferiority showed that the difference between the groups was |
| doi_str_mv | 10.1016/j.ajog.2020.03.017 |
| format | Article |
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The primary objective of this study was to compare patient satisfaction with postoperative pain control between patients receiving a routine or reduced quantity opioid prescription after prolapse repair. Secondary objectives included a comparison of opioid-related side-effects, the number of opioid tablets used, and the number of excess tablets prescribed between these groups.
This was a single-center, unmasked, 2-arm, randomized controlled noninferiority trial of women who underwent a prolapse repair with a planned overnight hospitalization. Patients were assigned randomly to 1 of 2 study arms: routine (28 tablets of oxycodone 5 mg) or reduced (5 tablets) prescription of opioid tablets. Patients were eligible if they were at least 18 years of age and undergoing a prolapse repair with an anticipated overnight hospital stay. Exclusion criteria included a history of chronic pain, preoperative opioid use, intolerance to study medication, or a score of ≥30 on the Pain Catastrophizing Scale. In addition to their opioid prescription, all patients received multimodal pain medications at discharge. Patients were asked to complete 6 weeks of diaries to record pain and medication use. The primary outcome (patient satisfaction) was collected as part of a postoperative survey completed at patients’ routine postoperative visit 6 weeks after surgery. The sample size for noninferiority was calculated at 59 patients per group for a total of 118 patients.
One hundred eighteen patients were assigned randomly; the primary outcome was available for 116. The majority of patients were white, postmenopausal, and nonsmokers; the mean age was 62±10.4 years. The most common surgery was a hysterectomy with native tissue repair (n=71; 60%). One hundred ten patients (93%) were satisfied with postoperative pain control. Statistical analysis constructed for noninferiority showed that the difference between the groups was <15% (93% vs 93%; P=.005). Subjects in the reduced arm reported requiring an additional opioid prescription more frequently than in the routine arm (15% vs 2%; P=.01). Patients in the routine arm used more opioid tablets than the reduced arm (median, 3 [interquartile range, 0–14] vs 1 [interquartile range, 0–3]), but overall opioid utilization was low. As such, patients in the routine arm had significantly more unused opioid tablets (median, 26 [interquartile range, 15–28] vs 4 [interquartile range, 2–5]).
Patient satisfaction with pain control was noninferior in patients who received a reduced quantity of opioid tablets after prolapse repair compared with those who received a routine prescription. A large quantity of excess opioid tablets was seen in both groups. Surgeons should consider prescribing 5–10 opioid tablets after prolapse repair surgery and consider applying these findings to postoperative prescribing after other gynecologic procedures.</description><identifier>ISSN: 0002-9378</identifier><identifier>EISSN: 1097-6868</identifier><identifier>DOI: 10.1016/j.ajog.2020.03.017</identifier><identifier>PMID: 32199926</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Analgesics, Opioid - administration & dosage ; Female ; Humans ; Hysterectomy ; Middle Aged ; opioid ; Opioid Epidemic ; Oxycodone - administration & dosage ; Pain Measurement ; Pain, Postoperative - drug therapy ; Patient Satisfaction ; Practice Patterns, Physicians ; prolapse surgery ; Reconstructive Surgical Procedures ; urogynecology ; Uterine Prolapse - surgery</subject><ispartof>American journal of obstetrics and gynecology, 2020-10, Vol.223 (4), p.547.e1-547.e12</ispartof><rights>2020 Elsevier Inc.</rights><rights>Copyright © 2020 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c400t-ea9caa10ee5fbdec2d921a629a23665716de1ceea34812e409e6df5b626ac7ec3</citedby><cites>FETCH-LOGICAL-c400t-ea9caa10ee5fbdec2d921a629a23665716de1ceea34812e409e6df5b626ac7ec3</cites><orcidid>0000-0003-2842-748X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ajog.2020.03.017$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32199926$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Davidson, Emily R.W.</creatorcontrib><creatorcontrib>Paraiso, Marie Fidela R.</creatorcontrib><creatorcontrib>Walters, Mark D.</creatorcontrib><creatorcontrib>Propst, Katie</creatorcontrib><creatorcontrib>Ridgeway, Beri</creatorcontrib><creatorcontrib>Yao, Meng</creatorcontrib><creatorcontrib>Ferrando, Cecile A.</creatorcontrib><title>A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair</title><title>American journal of obstetrics and gynecology</title><addtitle>Am J Obstet Gynecol</addtitle><description>Given the accelerating opioid crisis in the United States and evidence that patients use fewer opioid tablets than prescribed, surgeons may choose to decrease prescribed quantities. The effect this may have on patient satisfaction with pain control after hospital discharge is unknown.
The primary objective of this study was to compare patient satisfaction with postoperative pain control between patients receiving a routine or reduced quantity opioid prescription after prolapse repair. Secondary objectives included a comparison of opioid-related side-effects, the number of opioid tablets used, and the number of excess tablets prescribed between these groups.
This was a single-center, unmasked, 2-arm, randomized controlled noninferiority trial of women who underwent a prolapse repair with a planned overnight hospitalization. Patients were assigned randomly to 1 of 2 study arms: routine (28 tablets of oxycodone 5 mg) or reduced (5 tablets) prescription of opioid tablets. Patients were eligible if they were at least 18 years of age and undergoing a prolapse repair with an anticipated overnight hospital stay. Exclusion criteria included a history of chronic pain, preoperative opioid use, intolerance to study medication, or a score of ≥30 on the Pain Catastrophizing Scale. In addition to their opioid prescription, all patients received multimodal pain medications at discharge. Patients were asked to complete 6 weeks of diaries to record pain and medication use. The primary outcome (patient satisfaction) was collected as part of a postoperative survey completed at patients’ routine postoperative visit 6 weeks after surgery. The sample size for noninferiority was calculated at 59 patients per group for a total of 118 patients.
One hundred eighteen patients were assigned randomly; the primary outcome was available for 116. The majority of patients were white, postmenopausal, and nonsmokers; the mean age was 62±10.4 years. The most common surgery was a hysterectomy with native tissue repair (n=71; 60%). One hundred ten patients (93%) were satisfied with postoperative pain control. Statistical analysis constructed for noninferiority showed that the difference between the groups was <15% (93% vs 93%; P=.005). Subjects in the reduced arm reported requiring an additional opioid prescription more frequently than in the routine arm (15% vs 2%; P=.01). Patients in the routine arm used more opioid tablets than the reduced arm (median, 3 [interquartile range, 0–14] vs 1 [interquartile range, 0–3]), but overall opioid utilization was low. As such, patients in the routine arm had significantly more unused opioid tablets (median, 26 [interquartile range, 15–28] vs 4 [interquartile range, 2–5]).
Patient satisfaction with pain control was noninferior in patients who received a reduced quantity of opioid tablets after prolapse repair compared with those who received a routine prescription. A large quantity of excess opioid tablets was seen in both groups. Surgeons should consider prescribing 5–10 opioid tablets after prolapse repair surgery and consider applying these findings to postoperative prescribing after other gynecologic procedures.</description><subject>Aged</subject><subject>Analgesics, Opioid - administration & dosage</subject><subject>Female</subject><subject>Humans</subject><subject>Hysterectomy</subject><subject>Middle Aged</subject><subject>opioid</subject><subject>Opioid Epidemic</subject><subject>Oxycodone - administration & dosage</subject><subject>Pain Measurement</subject><subject>Pain, Postoperative - drug therapy</subject><subject>Patient Satisfaction</subject><subject>Practice Patterns, Physicians</subject><subject>prolapse surgery</subject><subject>Reconstructive Surgical Procedures</subject><subject>urogynecology</subject><subject>Uterine Prolapse - surgery</subject><issn>0002-9378</issn><issn>1097-6868</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kEFr3DAQhUVpaLZJ_kAPRcde7I7kXdmCXkJIm8JCL8lZaKVxmcUruZIcSH59tGyaY04zo3nvDfoY-yKgFSDU931r9_FvK0FCC10Lov_AVgJ036hBDR_ZCgBko7t-OGefc94fR6nlJ3beSaG1lmrFpmuebPDxQM_ouYuhpDhNtQ0xUBgxUUxUnnhJZCceR57QL67uHzNPcSkUkMeZInk-J8wu0VwoBm7Hgqk-xcnOGatrtpQu2dlop4xXr_WCPfy8vb-5a7Z_fv2-ud42bg1QGrTaWSsAcTPuPDrptRRWSW1lp9SmF8qjcIi2Ww9C4ho0Kj9udkoq63p03QX7dsqt9_8tmIs5UHY4TTZgXLKR3SCGtZKgqlSepC7FnBOOZk50sOnJCDBHymZvjpTNkbKBzlTK1fT1NX_ZHdC_Wf5jrYIfJwHWXz4SJpMdYajcKKErxkd6L_8FzRqRZw</recordid><startdate>202010</startdate><enddate>202010</enddate><creator>Davidson, Emily R.W.</creator><creator>Paraiso, Marie Fidela R.</creator><creator>Walters, Mark D.</creator><creator>Propst, Katie</creator><creator>Ridgeway, Beri</creator><creator>Yao, Meng</creator><creator>Ferrando, Cecile A.</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-2842-748X</orcidid></search><sort><creationdate>202010</creationdate><title>A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair</title><author>Davidson, Emily R.W. ; Paraiso, Marie Fidela R. ; Walters, Mark D. ; Propst, Katie ; Ridgeway, Beri ; Yao, Meng ; Ferrando, Cecile A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c400t-ea9caa10ee5fbdec2d921a629a23665716de1ceea34812e409e6df5b626ac7ec3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>Analgesics, Opioid - administration & dosage</topic><topic>Female</topic><topic>Humans</topic><topic>Hysterectomy</topic><topic>Middle Aged</topic><topic>opioid</topic><topic>Opioid Epidemic</topic><topic>Oxycodone - administration & dosage</topic><topic>Pain Measurement</topic><topic>Pain, Postoperative - drug therapy</topic><topic>Patient Satisfaction</topic><topic>Practice Patterns, Physicians</topic><topic>prolapse surgery</topic><topic>Reconstructive Surgical Procedures</topic><topic>urogynecology</topic><topic>Uterine Prolapse - surgery</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Davidson, Emily R.W.</creatorcontrib><creatorcontrib>Paraiso, Marie Fidela R.</creatorcontrib><creatorcontrib>Walters, Mark D.</creatorcontrib><creatorcontrib>Propst, Katie</creatorcontrib><creatorcontrib>Ridgeway, Beri</creatorcontrib><creatorcontrib>Yao, Meng</creatorcontrib><creatorcontrib>Ferrando, Cecile A.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>American journal of obstetrics and gynecology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Davidson, Emily R.W.</au><au>Paraiso, Marie Fidela R.</au><au>Walters, Mark D.</au><au>Propst, Katie</au><au>Ridgeway, Beri</au><au>Yao, Meng</au><au>Ferrando, Cecile A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair</atitle><jtitle>American journal of obstetrics and gynecology</jtitle><addtitle>Am J Obstet Gynecol</addtitle><date>2020-10</date><risdate>2020</risdate><volume>223</volume><issue>4</issue><spage>547.e1</spage><epage>547.e12</epage><pages>547.e1-547.e12</pages><issn>0002-9378</issn><eissn>1097-6868</eissn><abstract>Given the accelerating opioid crisis in the United States and evidence that patients use fewer opioid tablets than prescribed, surgeons may choose to decrease prescribed quantities. The effect this may have on patient satisfaction with pain control after hospital discharge is unknown.
The primary objective of this study was to compare patient satisfaction with postoperative pain control between patients receiving a routine or reduced quantity opioid prescription after prolapse repair. Secondary objectives included a comparison of opioid-related side-effects, the number of opioid tablets used, and the number of excess tablets prescribed between these groups.
This was a single-center, unmasked, 2-arm, randomized controlled noninferiority trial of women who underwent a prolapse repair with a planned overnight hospitalization. Patients were assigned randomly to 1 of 2 study arms: routine (28 tablets of oxycodone 5 mg) or reduced (5 tablets) prescription of opioid tablets. Patients were eligible if they were at least 18 years of age and undergoing a prolapse repair with an anticipated overnight hospital stay. Exclusion criteria included a history of chronic pain, preoperative opioid use, intolerance to study medication, or a score of ≥30 on the Pain Catastrophizing Scale. In addition to their opioid prescription, all patients received multimodal pain medications at discharge. Patients were asked to complete 6 weeks of diaries to record pain and medication use. The primary outcome (patient satisfaction) was collected as part of a postoperative survey completed at patients’ routine postoperative visit 6 weeks after surgery. The sample size for noninferiority was calculated at 59 patients per group for a total of 118 patients.
One hundred eighteen patients were assigned randomly; the primary outcome was available for 116. The majority of patients were white, postmenopausal, and nonsmokers; the mean age was 62±10.4 years. The most common surgery was a hysterectomy with native tissue repair (n=71; 60%). One hundred ten patients (93%) were satisfied with postoperative pain control. Statistical analysis constructed for noninferiority showed that the difference between the groups was <15% (93% vs 93%; P=.005). Subjects in the reduced arm reported requiring an additional opioid prescription more frequently than in the routine arm (15% vs 2%; P=.01). Patients in the routine arm used more opioid tablets than the reduced arm (median, 3 [interquartile range, 0–14] vs 1 [interquartile range, 0–3]), but overall opioid utilization was low. As such, patients in the routine arm had significantly more unused opioid tablets (median, 26 [interquartile range, 15–28] vs 4 [interquartile range, 2–5]).
Patient satisfaction with pain control was noninferior in patients who received a reduced quantity of opioid tablets after prolapse repair compared with those who received a routine prescription. A large quantity of excess opioid tablets was seen in both groups. Surgeons should consider prescribing 5–10 opioid tablets after prolapse repair surgery and consider applying these findings to postoperative prescribing after other gynecologic procedures.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>32199926</pmid><doi>10.1016/j.ajog.2020.03.017</doi><orcidid>https://orcid.org/0000-0003-2842-748X</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Analgesics, Opioid - administration & dosage Female Humans Hysterectomy Middle Aged opioid Opioid Epidemic Oxycodone - administration & dosage Pain Measurement Pain, Postoperative - drug therapy Patient Satisfaction Practice Patterns, Physicians prolapse surgery Reconstructive Surgical Procedures urogynecology Uterine Prolapse - surgery |
| title | A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair |
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