The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery

NCT ID: NCT03608436

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-24
• Study Completion Date: 2021-06-03

Brief Summary

Randomised controlled trial comparing the effect of low pressure pneumoperitoneum with deep neuromuscular block versus normal pressure pneumoperitoneum with moderate neuromuscular block during laparoscopic colorectal surgery on early quality of recovery.

Detailed Description

Rationale: the laparoscopic approach reduced trauma as compared to open surgery, however, the pressure used to create a PNP with sufficient surgical workspace still leads to significant tissue injury. Prior studies show that the use of low-pressure pneumoperitoneum (PNP) during laparoscopic surgery reduced postoperative pain scores, cumulative opioid consumption and improved bowel function recovery. Deep neuromuscular blockade (NMB) as compared to moderate NMB decreases the amount of intra-abdominal pressure required to achieve similar surgical conditions and enables the use of low-pressure PNP without compromising the quality of the surgical field and patient safety. Therefore, the use of deep NMB with low-pressure PNP could be a significant addition to the conventional Enhanced Recovery After Surgery (ERAS) protocols.

Objective: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and the early quality of recovery after laparoscopic colorectal surgery.

Study design: a multi-center, blinded, randomized controlled clinical trial.

Study population: adult individuals scheduled for laparoscopic colorectal surgery with a primary colonic anastomosis.

Intervention: participants will be randomly assigned in a 1:1 fashion to either the experimental group (group A): low pressure PNP (8 mmHg) with deep NMB (PTC 1-2) or the control group (group B): normal pressure PNP (12 mmHg) with moderate NMB (TOF count 1-2).

Primary endpoint: Quality of recovery score (QoR-40) 24 hours after surgery.

Secondary endpoints: QoR-40 score (day 3 and 7 after surgery), McGill pain- and RAND-36 score (1 day before and 3 months after surgery), pain scores, PONV, analgesia use, length of hospital stay, postoperative complications, surgical conditions and time to reach discharge criteria.

Conditions

Pneumoperitoneum; Neuromuscular Blockade; Surgery

Keywords

Quality of recovery; Laparoscopic surgery; Deep neuromuscular block; Low pressure pneumoperitoneum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Low pressure PNP, deep NMB

Low pressure pneumoperitoneum of 8 mmHg with deep neuromuscular block (post tetanic count of 1-2) reached by titration with continuous infusion of Rocuronium bromide.

Group Type: EXPERIMENTAL

Low pressure pneumoperitoneum

Intervention Type: PROCEDURE

Lowering intra-abdominal pressure during laparoscopic surgery

Rocuronium Bromide

Intervention Type: DRUG

Deep (PTC 1-2) versus moderate (Tof count 1-2) neuromuscular block

Normal pressure PNP, moderate NMB

Normal pressure pneumoperitoneum of 12 mmHg with moderate neuromuscular block (TOF count of 1-2) reached by titration with bolus or continuous infusion of a low dose of Rocuronium bromide.

Group Type: ACTIVE_COMPARATOR

Rocuronium Bromide

Intervention Type: DRUG

Deep (PTC 1-2) versus moderate (Tof count 1-2) neuromuscular block

Interventions

Low pressure pneumoperitoneum

Lowering intra-abdominal pressure during laparoscopic surgery

Intervention Type: PROCEDURE

Rocuronium Bromide

Deep (PTC 1-2) versus moderate (Tof count 1-2) neuromuscular block

Intervention Type: DRUG

Other Intervention Names

Low intra-abdominal pressure; Deep muscle relaxation

Eligibility Criteria

Inclusion Criteria

• Scheduled for laparoscopic colorectal surgery with a primary anastomosis
• Obtained informed consent
• Age over 18 years

Exclusion Criteria

• Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
• Primary colostomy
• Neo-adjuvant chemotherapy
• Chronic use of analgesics or psychotropic drugs
• Use of NSAIDs shorter than 5 days before surgery
• Known or suspected allergy to rocuronium of sugammadex
• Neuromuscular disease
• Indication for rapid sequence induction
• Severe liver- or renal disease (creatinine clearance <30ml/min)
• BMI >35 kg/m²
• Deficiency of vitamin K dependent clotting factors or coagulopathy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim I Albers, MD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Michiel C Warlé, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Martini general hospital

Groningen, , Netherlands

Maxima Medisch Centrum

Veldhoven, , Netherlands

Countries

Netherlands

References

Albers KI, Polat F, Panhuizen IF, Snoeck MMJ, Scheffer GJ, de Boer HD, Warle MC. The effect of low- versus normal-pressure pneumoperitoneum during laparoscopic colorectal surgery on the early quality of recovery with perioperative care according to the enhanced recovery principles (RECOVER): study protocol for a randomized controlled study. Trials. 2020 Jun 17;21(1):541. doi: 10.1186/s13063-020-04496-8.

Reference Type: DERIVED

PMID: 32552782 (View on PubMed)

Other Identifiers

NL65290.091.18

Identifier Type: -

Identifier Source: org_study_id