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Completed

NCT Number: NCT05341869

PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY

Total hysterectomy is one of the most common surgical procedure in gynecology. The laparoscopic route for the performance of hysterectomies are on the rise [1]. The laparoscopic hysterectomy (TLH) procedure has several advantages over open surgery such as better cosmetic outcomes, faster recovery earlier return to normal activities and work [1-3]. Nonetheless, postoperative pain (PP) remains an issue that scuppers these advantages [1-3].

The incidence of PP after TLH has been reported to vary from 35% to 63% [4,5]. The origin of PP after laparoscopy is multifactorial and complex such as perioperative predicaments, including pneumoperitoneum, stretching of the intraabdominal cavity, the blood left in the abdomen, and dissection of the pelvic region [6-7]. A randomized controlled trial has demonstrated that there may be more intense pain and greater analgesia requirements in the immediate postoperative period after laparoscopic surgery than after laparotomy [8]. Further inquiry to intercept the advancement and decrease the severity of PP is prominent to further improve TLH.

Women undergoing TLH experience two different pain characteristics including incisional pain and visceral pain in the first hour after the operation [6]. These pains were most intense 30 min after TLH, gradually decreasing thereafter for postoperative 72 hr [6]. High levels of acute postoperative pain (APP) are pertain with an increment risk of chronic postsurgical pain so control of these acute pains in the urgent postoperative period is vital for faster amelioration.

Many attempts have been tried to control APP after THL, such as transverse abdominal plane blocks, superior hypogastric plexus block, local anesthetic injection to the port side, and reduced port caliber [9-12]. Para-cervical bloc (PCB) is believed to block the Frankenhouser nerve plexus that supplies the visceral sensory fibers to the uterus, cervix, and top of the vagina. Only two randomized studies have assessed the effect of PCB in THL, but several limitations such as the small sample size preclude drawing conclusions on PP after TLH. Thus, the primary goal of this randomized clinical trial was to investigate if PCB at the onset of surgery, as a part of enhanced recovery protocol, could improve patient recovery after THL.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mugla Sıtkı Kocman University Education and Research Hospital, Muğla, Mentese, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-Patients undergoing total type A laparoscopic hysterectomy with or without additional surgery, such as salpingo-oophorectomy or salpingectomy

Exclusion criteria

  • age < 18 years
  • refusal to provide consent
  • inability to understand the study questionnaire
  • severe psychiatric or mental disorder
  • American Society of Anesthesiologists (ASA) physical status classification > III
  • history of regular narcotic use within 6 months of the surgery
  • conversion to laparotomy
  • operation time > 90 min
  • Additional procedures

Treatment and study plan

Para-cervical block

Procedure

Block of inferior hypogastric plexus with local anesthetic

Primary outcomes

  1. visual analog scale (VAS) pain score

    Time frame: up to 1 hour after the procedure

    1 h postoperative visual analog scale (VAS) pain score

Secondary outcomes

  1. the quality of postoperative recovery

    Time frame: Up to 24 hours after the procedure

    the quality of postoperative recovery according to the QoR-40 questionnaire scores at 24 hours after the surgical procedure

  2. faces pain scale-revised score

    Time frame: up to 2,4,6,12 hours after the procedure

    Faces pain scale-revised score is an objective method of pain assessment in which facial expressions of the patient are assessed by the investigator

Sponsors and collaborators

Lead sponsor

Erzincan Military Hospital

Other

Registry information

Official study title

PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY: A RANDOMIZED PLACEBO CONTROLLED TRIAL

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 22, 2022
Registry last updated
Feb 22, 2023

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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