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It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic conditions on postoperative pain relief.
Postoperative pain management is an important component of patient care and satisfaction after surgery. Although contemporary changes such as a shift to minimally invasive approaches and an introduction of the enhanced recovery after surgery (ERAS) program have resulted in improved outcomes, a large number of patients undergoing surgery have still inadequate pain control. Paracervical block is a single-injection of anesthetic around the cervix at a depth of about 1 cm, diffusing anesthetic into the second to fourth sacral nerve roots passing through Frankenhäuser plexus. Moreover, recent randomized trials demonstrated that patients who underwent vaginal hysterectomy and received a paracervical block had lower postoperative pain in the first 3-6 hours compared with placebo.
However, it remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic conditions on postoperative pain relief.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracervical block with 5% bupivacaine | Experimental | The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix. |
|
| Paracervical block with normal saline | Placebo Comparator | The paracervical injection with 10 mL of normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracervical block | Device | The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine or normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain". | at 6-hour after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of pills/injections requested | Narcotic and non-narcotic use were measured by number of pills/injections requested within 24-hour after surgery. | Within 24-hour after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taejong Song, M.D., Ph.D. | Contact | +821040358405 | taejong.song@gmail.com | |
| Su Yaen Kim, M.D. | Contact | +82220012036 | suyeon0819.kim@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Taejong Song, M.D., Ph.D. | Kangbuk Samsung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Suspended | Seoul | 03181 | South Korea | ||
| Kangbuk Samsung Hospital |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 31, 2020 | |
| Unrelease | Jan 18, 2021 | |
| Release | Jan 18, 2021 | |
| Reset | Feb 5, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 31, 2020 | Jan 18, 2021 | |||
| Jan 18, 2021 |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000773 | Anesthesia, Obstetrical |
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
| D000577 | Amides |
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|
|
| 5% bupivacaine | Drug | The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix. |
|
|
| Normal saline | Drug | The paracervical injection with 10 mL of normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix. |
|
|
| Recruiting |
| Seoul |
| 110-746 |
| South Korea |
|
| Wonju Severance Christian Hospital | Recruiting | Wŏnju | South Korea |
|
| Feb 5, 2021 |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009930 |
| Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |