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The purpose of this study is to determine the effect of decreased insufflation pressure on postoperative pain, analgesic use, and surgical safety and feasibility for laparoscopic hysterectomy.
This is a prospective, single-blinded, randomized clinical trial in which participants undergoing laparoscopic hysterectomy will be randomized in a 1:1 ratio to undergo surgery with peritoneal insufflation pressure set to 15 mmHg (standard) or 12 mmHg (comparison). Randomization was performed using computer-generated permuted blocks of four participants. All participants on the first postoperative day will be asked to rate their pain with a Visual Analog Scale (VAS). At a postoperative visit 2 weeks after surgery, all participants will be asked to complete the VAS again. The highest preoperative pain (up to 2 hours before surgery) and immediate postoperative pain, using the VAS, in the post anesthesia care unit (PACU) will be recorded. All participants will be planned for discharge from PACU. Age, body mass index, gynecologic diagnosis, medical history, and preoperative analgesia or opioid use will be extracted from the medical records by trained research staff and entered into a secure electronic database. Preoperative analgesia and opioid saw will be verified with active prescription records at the time of surgery. After surgery, analgesic doses, operative time, additional procedures performed, conversion to laparotomy or increased insufflation pressure, estimated blood loss, and length of stay will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 mmHg Insufflation Pressure | Experimental | Participants received 12 mmHg of insufflation pressure during their laparoscopic hysterectomy. |
|
| 15 mmHg Insufflation Pressure | Active Comparator | Participants received 15 mmHg of insufflation pressure during their laparoscopic hysterectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower Insufflation Pressure | Procedure | Participants underwent laparoscopic hysterectomy with an insufflation pressure that is lower than the standard insufflation pressure used in this type of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain on postoperative day 1 | All participants will be asked to rate their pain using the Visual Analog Scale (VAS) approximately 24 hours after surgery completion. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain. | 24 hours following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative pain | All participants will be asked to rate their pain using the Visual Analog Scale (VAS) upon their arrival before surgery. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain. | Within 2 hours before surgery |
| Postoperative pain while in PACU |
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Inclusion Criteria:
Exclusion Criteria:
Women who are biologically female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Health Science Center | Recruiting | Memphis | Tennessee | 38103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37348093 | Background | Rustia GM, Baracy MG Jr, Khair E, Hagglund KH, Aslam MF. Pain With Differing Insufflation Pressures During Robotic Sacrocolpopexy: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jul 1;142(1):151-159. doi: 10.1097/AOG.0000000000005231. Epub 2023 Jun 7. | |
| 28602786 | Background | Song T, Kim KH, Lee KW. The Intensity of Postlaparoscopic Shoulder Pain Is Positively Correlated with the Amount of Residual Pneumoperitoneum. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):984-989.e1. doi: 10.1016/j.jmig.2017.06.002. Epub 2017 Jun 7. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2024 | Jul 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2024 | Jul 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Standard Insufflation Pressure | Procedure | Participants underwent laparoscopic hysterectomy with a standard insufflation pressure. |
|
All participants will be asked to rate their pain using the Visual Analog Scale (VAS) while they are recovering in PACU, approximately 2 hours after surgery completion. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain. |
| Approximately 2 hours after surgery completion |
| Postoperative pain at follow-up visit | All participants will be asked to rate their pain using the Visual Analog Scale (VAS) at their 2-week postoperative follow-up visit. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain. | Approximately 2 weeks after surgery completion |
| Opioid use after discharge | All participants will be asked about the number of prescription opioid pills they took following discharge. | Within 2 weeks after surgery |
| 26955258 | Background | Kyle EB, Maheux-Lacroix S, Boutin A, Laberge PY, Lemyre M. Low vs Standard Pressures in Gynecologic Laparoscopy: a Systematic Review. JSLS. 2016 Jan-Mar;20(1):e2015.00113. doi: 10.4293/JSLS.2015.00113. |
| 27679192 | Background | Grant A, Keltz J, Huang K. Is Decreased Insufflation Pressure During Major Robotic-Assisted Gynecologic Surgery Associated With Decreased Recovery Time and Patient Reported Pain Score. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S26. doi: 10.1016/j.jmig.2015.08.075. Epub 2015 Oct 15. No abstract available. |
| 25265495 | Background | Topcu HO, Cavkaytar S, Kokanali K, Guzel AI, Islimye M, Doganay M. A prospective randomized trial of postoperative pain following different insufflation pressures during gynecologic laparoscopy. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:81-5. doi: 10.1016/j.ejogrb.2014.09.003. Epub 2014 Sep 16. |
| 25260990 | Background | Angioli R, Terranova C, Plotti F, Cafa EV, Gennari P, Ricciardi R, Aloisi A, Miranda A, Montera R, De Cicco Nardone C. Influence of pneumoperitoneum pressure on surgical field during robotic and laparoscopic surgery: a comparative study. Arch Gynecol Obstet. 2015 Apr;291(4):865-8. doi: 10.1007/s00404-014-3494-z. Epub 2014 Sep 27. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |