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NCT Number: NCT06508814

Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee Health Science Center

Memphis, Tennessee, 38103, United States

Location status: Recruiting

Location contact

Alex Samborski, MD

SUB_INVESTIGATOR

Amira Wohabrebbi, PhD

CONTACT

[email protected]

901-545-7453

Annette Hickerson, RN

CONTACT

[email protected]

901-448-4784

Daniel Amran, BS

SUB_INVESTIGATOR

Emma Ryan, BS

SUB_INVESTIGATOR

Jenny Stapel, MD

SUB_INVESTIGATOR

John O Schorge, MD

PRINCIPAL_INVESTIGATOR

Riley Short, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Standard Insufflation Pressure

Procedure

Participants underwent laparoscopic hysterectomy with a standard insufflation pressure.

Primary outcomes

  1. Pain on postoperative day 1

    Time frame: 24 hours following surgery

    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.

Secondary outcomes

  1. Preoperative pain

    Time frame: Within 2 hours before surgery

    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.

  2. Postoperative pain while in PACU

    Time frame: Approximately 2 hours after surgery completion

    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.

  3. Postoperative pain at follow-up visit

    Time frame: Approximately 2 weeks after surgery completion

    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.

  4. Opioid use after discharge

    Time frame: Within 2 weeks after surgery

    All participants will be asked about the number of prescription opioid pills they took following discharge.

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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