Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy

NCT06508814 | Recruiting

• 1 other identifier: 24-09977-FB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Preoperative pain

  Within 2 hours before surgery

• Postoperative pain while in PACU

  Approximately 2 hours after surgery completion

• Postoperative pain at follow-up visit

  Approximately 2 weeks after surgery completion

• Opioid use after discharge

  Within 2 weeks after surgery

Study Arms (2)

12 mmHg Insufflation Pressure

EXPERIMENTAL

Participants received 12 mmHg of insufflation pressure during their laparoscopic hysterectomy.

Procedure: Lower Insufflation Pressure

15 mmHg Insufflation Pressure

ACTIVE COMPARATOR

Participants received 15 mmHg of insufflation pressure during their laparoscopic hysterectomy.

Procedure: Standard Insufflation Pressure

Interventions

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.

12 mmHg Insufflation Pressure

Standard Insufflation Pressure PROCEDURE

Participants underwent laparoscopic hysterectomy with a standard insufflation pressure.

15 mmHg Insufflation Pressure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Women who are biologically female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 to 80
• BMI 55.0 or less
• Laparoscopic hysterectomy surgery planned

You may not qualify if:

• Women younger than 18 or older than 80 years of age
• BMI over 55.0
• Laparoscopic hysterectomy surgery not planned

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38103, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 37348093 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.

  PMID: 28602786 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.

  PMID: 26955258 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.

  PMID: 27679192 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.

  PMID: 25265495 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.

  PMID: 25260990 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: June 10, 2024
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)